Project budding

We have learned about the negative impact caused by intestinal flora imbalance in our Clinical

Medicine Apprenticeship,and the association between the intestinal flora and systemic diseases.Further learning about the treatment for gut flora imbalance makes us learned about flora transplantation,which is the trerapeutic strategy that invloves transplanting faecal preparations from healthy gut populations to patients with gut flora disorders. However there is a significant psychological barriers to be overcome for patients undergoing faecal flora transplantation.Moreover,standardisation and homogenisation of faecal flora preparations is difficult, which limits its further widespread use.

It is the time that one student's yoghurt piqued our interest during the group discussion. "Probiotics" are a frequent component of yoghurt and health supplements, and many product descriptions boast that the added probiotics and prebiotics can promote digestion and maintain intestinal stability. However, the probiotic component in food is not enough to address the imbalance of intestinal flora, as the number and function of probiotics are limited. Therefore, "Gut Guard", a project programme based on engineered probiotic strains, was born.

Explore and interview

In the process of commercialisation exploration, we first took basic research as a starting point, and through systematic study of award-winning business plan cases in the past years and many in-depth industry research materials, we comprehensively grasped the business logic, market trends and the core elements of successful projects, and laid a solid cognitive foundation for the follow-up work. On top of that, we fully integrated the ideas and insights of the team members through multiple forms of collaboration, such as offline group meetings and online real-time communication, to gradually clarify the core direction of the business plan, and ultimately established a preliminary overall framework and medium- and long-term development plan.

In addition, we also explored the actual needs of the market through field research and took the initiative to carry out in-depth exchanges with other outstanding innovation and entrepreneurship teams. This series of practice has given us a more intuitive and profound preliminary knowledge of the suitability of mainstream entrepreneurial models in the industry, the core resources required for project promotion, and the challenges we may face in the future, such as market competition and operational risks, which further provides practical support for the feasibility of the business plan on the ground.

After completing the initial knowledge of the innovation and entrepreneurship field, in order to further explore the market feasibility and potential of our product, we conducted targeted interviews with the medical industry, and had in-depth exchanges with a number of professional doctors and patients, obtaining valuable feedback.

In the doctor interviews, doctors with different professional backgrounds provided differentiated key suggestions from their respective fields. One of the doctors focused on the core of product development, combined with clinical needs and the current market situation, clearly explained the core conditions and key technical indicators that the current market urgently needs products should have, and gave specific guidance on how to verify the practicality of the product through scientific methods in the process of product promotion, which provided important references to the optimisation of the product development path. Another doctor focused on the field of intestinal health, highlighting the importance of intestinal probiotics in clinical application, and introducing in detail the standard process, key nodes and data evaluation requirements for the conduct of clinical trials of this type of products, which laid a cognitive foundation for the subsequent conduct of compliance trials of our products.

In addition to the physician group, we also communicated with a representative of the target patient group. After clearly explaining the core functions, application scenarios and advantages of our product, we patiently answered his questions about the use of the product, safety and effect expectations. At the end of the communication, the patient clearly expressed his interest in our product and his preference, which directly reflected the acceptance of the product by the target users and provided strong market support for the successful launch of the product in the future.

After optimising the experiment accordingly, we conducted further interviews. We interviewed Mr Liu Jinghong, General Manager and Founder of Jinghong Health Products Ltd, a "China Preferred Brand".

Mr Liu Jinghong gave us a lot of advice on how to manage a good team, how to build a good corporate culture and how to make a good product. In his opinion, a good product consists of three aspects, i.e. technology, formulation and packaging appearance. Doing a good job on a product is not an easy task, and it requires strong multi-team collaboration behind it. In terms of technology, there is a need for an advanced technical team, with the technical team as a foundation, in order to develop a good formula, and only a good formula is not enough, the third element is also very important, that is, excellent product packaging design. Do a product, is a process from the inside out, and from the outside in. Not only the appearance of the design, this aspect also includes the design of the corporate culture and the design of the product background story, a good product not only need to have its shell and connotation, but also need to have a soul, need to have the corresponding story and corporate culture content as support. He said if we want to lead a team or start a business in the future, we need to focus on the corporate culture and the story behind it. We Chinese can use more Chinese style, after all, that is our speciality. In addition, the content of product brochures should be written in a sensible way. For example, Jinghong's brochures will include appropriate references, and this kind of rigour and seriousness is something that can be directly differentiated from the practices of many companies.

Dialogue with Manager Liu let us gain a lot, we not only learned how to do a good product, how to improve our project, but also understand how to do a good business. We realised what kind of ability and quality a good entrepreneur should have. We also benefited from Manager Liu's emphasis on intellectual property protection. We would like to express our sincere gratitude to Manager Liu. Mr Liu received us warmly and was very happy to share his experience and knowledge with us, and invited us to visit his offline shop, which gave us a deeper understanding of how a healthcare company should survive and grow in China. At the shop, Manager Liu introduced us to the location of the shop, how to make a profit, and explained some of the laws and regulations of the healthcare market in China. Manager Liu further introduced us to the types, differences and characteristics of the products that Jinghong carries. Through the knowledge imparted by Manager Liu, we were able to further refine our thoughts about the subsequent transformation of the project. Innovation and change, it seems not difficult to say, but not easy to do; however, as long as we persevere and find the right way, it seems not so difficult.

When we were leaving, Manager Liu also gave us some company products for us to experience, and encouraged us to insist on studying hard and making progress, and strive for good results in this year's competition. Whether it is in the production of the most basic promotional materials or in the learning of Chinese business model, we all think that Manager Liu has taught us a lot of things. After finishing the interview with Manager Liu, our field trip and research on entrepreneurship came to an end. We wrote a business plan and hope to explore more deeply in entreprene.

1 Theme and Vision

1.1 Theme Statement

The theme concept of the team is "Digestive Health, Whole Body Health", which aims to break the traditional perception that the digestive system only undertakes the function of nutrient digestion and absorption, and to reveal the key position of the digestive system as the core hub of the body's physiological function regulation. The aim is to enhance people's knowledge of gastrointestinal health and improve their health.

1.1.1 Theme Connotation

From the point of view of physiological mechanisms, the digestive system is the primary interface for material exchange between the human body and the external environment. While processing a large amount of food substrate daily, it also needs to maintain the integrity of the intestinal mucosal barrier, the dynamic balance of the intestinal flora, and the stability of the immune defence. Its state of health not only directly determines the efficiency of nutrient decomposition and conversion (e.g. carbohydrates, proteins, fats, vitamins and minerals), but also through multi-organ interaction pathways such as the "intestinal-cerebral axis", "intestinal-hepatic axis" and "intestinal-lung axis". Through the "intestine-brain axis", "intestine-liver axis", "intestine-lung axis" and other multi-organ interaction pathways, it has a systematic impact on the functional homeostasis of various systems in the whole body.

From the perspective of modern medicine, the core of digestive health can be summarised as "three-dimensional balance": first, the balance of intestinal flora, i.e. the proportion of beneficial bacteria (e.g. Lactobacillus, Bifidobacterium) and harmful bacteria (e.g. Staphylococcus, Pseudomonas) is coordinated and the homeostasis of the metabolites of the flora (e.g. short-chain fatty acids, tryptophan metabolites, TMAO) is achieved. Secondly, the intestinal mucosal barrier balance, including the integrity and synergy of the physical barrier, also known as the mechanical barrier (tight junctions of epithelial cells), the chemical barrier (mucus layer, antimicrobial peptides), the microbial barrier (mucosal flora and intestinal luminal flora), and the immune barrier (intestinal-associated lymphoid tissues); and thirdly, digestive metabolism balance, which refers to the orderly and efficient secretion of digestive enzymes, gastrointestinal dynamics regulation, and the process of nutrient absorption and transit. These three balances are interrelated and interact with each other to form the basis of digestive health, and any imbalance in any one of these dimensions may trigger a "butterfly effect", which can be transmitted to the whole body system to induce health problems.

1.1.2 The importance of digestive health to general health

Nutritional supply: The digestive system is the "processing plant" and "transfer station" for human nutritional intake. After the food is chewed in the mouth and initially digested in the stomach, it is broken down by digestive enzymes such as pancreatic fluid and intestinal fluid into small molecules such as glucose, amino acids and fatty acids, and then enters into the blood circulation through the transporter of the epithelial cells of the small intestinal villi to provide energy and synthetic raw materials for the tissues and organs of the whole body. If the function of digestive system is impaired (such as the reduction of absorption area of intestinal mucosa caused by chronic enteritis, insufficient secretion of digestive enzymes caused by pancreatic insufficiency, etc.), it will directly trigger nutritional absorption disorders, leading to anaemia, osteoporosis, immune deficiency and other systemic nutritional diseases, and in serious cases, it even affects children's growth and development and the maintenance of organ function in adults.

Immune defence: The intestine is the largest immune organ in the human body, and the gut-associated lymphoid tissue (GALT) accounts for more than 70% of the total number of immune cells in the whole body, including T-cells, B-cells, macrophages, dendritic cells and other immune cells, as well as immune molecules such as secretory immunoglobulin A (sIgA). A healthy digestive system, through the dual regulation of "immune tolerance" and "immune defence", can not only identify and remove pathogenic bacteria, toxins and other harmful substances, but also avoid excessive immune responses (e.g., allergies, inflammation) to food antigens and beneficial flora. When the intestinal mucosal barrier is compromised (e.g., increased intestinal permeability, i.e., "leaky gut"), endotoxins (e.g., the lipopolysaccharide LPS) in the gut enter the blood circulation and activate the systemic inflammatory response system, inducing a chronic low-grade inflammatory state. This chronic inflammation is the common pathological basis of many chronic diseases such as obesity, type 2 diabetes, cardiovascular disease, and autoimmune diseases (e.g., rheumatoid arthritis), highlighting the central role of digestive health in maintaining systemic immune homeostasis.

Metabolic regulation: Intestinal flora, as the "second genome of the human body", is closely related to the metabolic health of the human body. Beneficial bacteria can produce short-chain fatty acids (SCFAs) through fermentation of dietary fibre, of which butyric acid is the main source of energy for colonic epithelial cells, and can promote the repair of intestinal mucous membranes; propionic acid can be used in the liver through the blood circulation to inhibit gluconeogenesis and regulate the level of blood glucose; and acetic acid can be used in the adipose tissue to inhibit the synthesis of fat. In addition, the intestinal flora also participates in the hepatic and intestinal cycles of bile acids, and through the dehydroxylation and dehydrogenation of primary bile acids, secondary bile acids are generated, which in turn regulate hepatic fat metabolism and cholesterol synthesis. When the intestinal flora is imbalanced (e.g. increase of harmful bacteria and decrease of beneficial bacteria), the production of SCFAs decreases and the metabolism of secondary bile acids is disturbed, which will lead to a significant increase in the risk of metabolic diseases, such as insulin resistance, dyslipidemia, NAFLD, etc., and even lead to obesity and its related complications.

Neural regulation: The "gut-brain axis" is an important pathway connecting the digestive system and the central nervous system, and it can achieve two-way regulation through the three major pathways of nerves, endocrine and immunity. Intestinal flora can affect the central nervous system function through metabolites (such as SCFAs, tryptophan metabolite 5-hydroxytryptophan precursor): for example, 5-hydroxytryptophan, as an important neurotransmitter, not only participates in the regulation of gastrointestinal dynamics, but also enters into the brain through the blood circulation, affecting the mood, sleep and cognitive function; SCFAs can pass through the blood-brain barrier, regulate the activity of microglia, inhibit neuroinflammation, and have a positive effect on the development of Alzheimer's disease, Parkinson's disease, and other diseases. Alzheimer's disease, Parkinson's disease and other neurodegenerative diseases have potential protective effects. When the intestinal flora is imbalanced, the regulation of the "gut-brain axis" is disturbed, which may induce anxiety, depression and other psychosomatic problems, as well as irritable bowel syndrome (IBS) and other "psychosomatic disorders", which reflects the important impact of digestive health on the health of the nervous system.

1.1.3 Correlation between digestive health and systemic health

Intestinal-liver axis: as the largest metabolic organ in the body, the liver is directly connected to the intestinal tract through the portal vein system, and nutrients, bacterial metabolites, and endotoxins in the intestinal tract need to be processed by entering the liver through the portal vein. In a healthy state, the liver can remove harmful substances from the intestinal tract through detoxification, and at the same time provide the intestinal tract with digestive aids such as bile acids; however, when there is an imbalance in the intestinal flora (e.g., an increase in the number of harmful bacteria leads to an increase in the production of endotoxin) or the intestinal mucosal barrier is impaired (an increase in endotoxin entry into the bloodstream), excessive endotoxin activates an inflammatory response in the liver, which induces damage to the hepatocytes and hepatic fibrosis, and in the long term can lead to liver cirrhosis and liver failure. , and liver failure. In addition, bile acid metabolism disorders involved in intestinal flora can lead to increased fat synthesis in the liver, inducing non-alcoholic fatty liver disease (NAFLD), and further development of NAFLD can lead to non-alcoholic steatohepatitis (NASH), hepatocellular carcinoma and other serious liver diseases, resulting in a vicious cycle of "intestinal imbalance - liver damage".

Intestinal-lung axis: Although the intestines and lungs are anatomically distant from each other, they are closely related through migration of immune cells, cytokine signalling and diffusion of flora metabolites. When the intestinal flora is imbalanced, the inflammatory factors produced in the intestines will enter the blood circulation and activate the immune cells in the lungs, inducing chronic inflammation in the lungs; at the same time, some metabolites of the intestinal flora can reach the lungs through the bloodstream, destroying the barrier of the lung mucous membranes, and increasing the risk of lung infections (e.g., pneumonia). In addition, the occurrence of respiratory diseases, such as allergic asthma, is also closely related to the abnormalities of immune tolerance caused by the imbalance of intestinal flora: insufficient diversity of intestinal flora in childhood leads to the over-activation of Th2-type immune responses and increases the probability of asthmaClinical studies have shown that symptom severity and lung function in asthma patients can be improved by regulating gut flora (e.g., probiotic supplementation), confirming the strong link between digestive health and lung health.

[ T. Y. Cui, J. R. Liu, B. Lv, et al. Research progress on the relationship between intestinal flora and immune regulation and childhood asthma[J]. Chinese Family Medicine,2022,25(8):1021-1026. DOI:10.12114/j.issn.1007-9572.2021.01.045.].

Gut-skin axis: As the largest surface barrier of the human body, the health of the skin is closely related to the function of the intestinal tract, which is reflected in the mechanism of "enterogenic dermatoses" (e.g. acne, psoriasis). When the intestinal flora is imbalanced, intestinal permeability increases, endotoxins and food antigens enter the blood circulation and activate systemic inflammatory responses, leading to abnormal proliferation of keratinocytes and sebaceous gland secretion disorders, which in turn induce acne; at the same time, metabolic disorders of the intestinal flora can lead to inadequate absorption of B vitamins (e.g., vitamins B2 and B6), which are key nutrients for skin mucosal repair, and their deficiency can exacerbate Skin inflammation. In addition, gut flora can influence the skin's immune defences by regulating the immune system: for example, SCFAs produced by beneficial bacteria can suppress skin inflammation, whereas endotoxins produced by harmful bacteria can trigger skin allergies, further demonstrating the intrinsic link between digestive health and skin health.

Intestinal-Cardiovascular Axis: The occurrence of cardiovascular diseases is closely related to intestinal health, and the core mechanism lies in the role of intestinal flora metabolites in regulating the cardiovascular system. Intestinal flora can metabolise choline and phosphatidylcholine from food into trimethylamine (TMA), which is oxidised by the liver to produce trimethylamine N-oxide (TMAO) [ WANG Z N, WILSON TANG W H, BUFFA J A, et al. Prognostic value of choline and betaine depends on intestinal microbiota-generated metabolite trimethylamine-N-oxide[J]. Eur Heart J, 2014, 35(14): 904-910. ].TMAO promotes vascular endothelial cell damage, atherosclerotic plaque formation, and increases the risk of hypertension, coronary heart disease, myocardial infarction, and stroke. Clinical studies have shown that the proportion of TMA-producing harmful bacteria in the intestinal flora of patients with cardiovascular disease is significantly higher than that of healthy people, and that the level of TMAO in the blood is positively correlated with the severity of cardiovascular disease. In addition, chronic low-grade inflammation caused by imbalance of intestinal flora will further aggravate the vascular inflammatory response and accelerate the process of atherosclerosis; whereas SCFAs produced by beneficial bacteria can play a protective role in the cardiovascular system by dilating blood vessels, lowering blood pressure and inhibiting inflammation. Therefore, maintaining digestive health (especially the balance of intestinal flora) has become an important new target for the prevention and adjuvant treatment of cardiovascular diseases.

1.2 Vision Complement

1.2.1 Social impact of long-term development

Reduce the incidence of digestive diseases and reduce the burden of public health: China is a country with high incidence of digestive diseases, this project is based on metabolically engineered probiotic capsules, targeting the clinical pain point of perioperative intestinal flora imbalance, and will subsequently gradually expand to the adjuvant intervention in the associated fields of chronic digestive diseases (e.g., IBS, inflammatory bowel disease), and metabolic diseases (e.g., obesity, type 2 diabetes mellitus). Through long-term promotion and application, it is expected to reduce the incidence of diseases related to intestinal flora imbalance in the target population by 15%-20%, reduce the number of outpatient visits related to digestive diseases by 10%-15%, alleviate the status quo of China's strained healthcare resources, and reduce the pressure on the operation of the public health system.

Enhance the digestive health literacy of the whole population and promote the popularity of healthy lifestyles: At present, there is a common misunderstanding among the residents of China about digestive health, which is "focusing on treatment but not on prevention" and "focusing on symptoms but not on the mechanism", such as ignoring the influence of dietary structure on intestinal flora, delaying intervention by simply attributing symptoms such as "constipation" and "diarrhoea" to "fire", and destroying intestinal flora by abusing antibiotics. For example, ignoring the influence of dietary structure on intestinal flora, delaying intervention by simply attributing symptoms such as "constipation" and "diarrhoea" to "fire", and destroying the intestinal flora by abusing antibiotics, and so on. In the process of product promotion, the project will simultaneously carry out digestive health education. Through cooperation with community health service centres, hospital gastroenterology departments and health management institutions, the project will produce easy-to-understand scientific content (such as brochures, short videos, and live broadcasting courses) to popularize scientific knowledge of the "balance of intestinal flora", "intestinal-whole-body axis", etc., and promote the use of the product in a variety of ways. axis" and other scientific knowledge to guide residents to establish the concept of "prevention first, scientific intervention" in digestive health management. It is expected that within five years of implementation, the digestive health literacy rate of the covered population will increase to more than 60%, the rate of antibiotic abuse will decrease by 10%, and the rate of dietary fibre intake will increase by 15%, thus reducing the risk of digestive diseases at source.

Contribute to the "Healthy China 2030" strategy [https://www.gov.cn/zhengce/2016-10/25/content_5124174.htm] and promote the prevention and control of chronic diseases: The "Healthy China 2030" plan outline clearly proposes that the "Healthy China 2030" strategy should be implemented. The outline of the "Healthy China 2030" plan clearly puts forward "the implementation of a comprehensive strategy for the prevention and control of chronic diseases, and the reduction of premature mortality from major chronic diseases", and digestive health is an important link in the prevention and control of chronic diseases - as mentioned earlier, the imbalance of intestinal flora is associated with obesity, type 2 diabetes, cardiovascular diseases, non-cancer diseases, and other chronic diseases. type diabetes, cardiovascular disease, non-alcoholic fatty liver disease and other chronic diseases. The metabolically engineered probiotic capsules of this project can not only directly improve digestive health, but also provide a new means of prevention and adjuvant treatment of chronic diseases by regulating the metabolism of intestinal flora and inhibiting chronic inflammation. For example, in obese people, the product can suppress appetite and promote fat decomposition by increasing the production of SCFAs; in type 2 diabetes patients, it can assist in lowering blood sugar by improving insulin resistance. The project plans to cooperate with primary healthcare institutions and incorporate the product into the health management programme for people with high risk of chronic diseases. It is expected that within 10 years of the project implementation, the growth rate of obesity, type 2 diabetes and other metabolic diseases will be reduced by 10-20% in the covered areas, which will provide a strong support for the achievement of the strategic goal of "Healthy China 2030".

Promote the integration of traditional Chinese medicine and modern biotechnology, inheritance and innovation of national medicine: China's traditional Chinese medicine contains a wealth of "intestinal conditioning" wisdom, Chinese medicine often said that "the spleen is the foundation of the day after tomorrow, the source of qi and blood biochemistry", which emphasises the importance of the spleen and stomach function on the health of the whole body; Chinese medicine also has a number of traditional Chinese medicines, which are used in the treatment of obesity and diabetes. In Chinese medicine, there are many formulas to regulate the intestinal function by strengthening the spleen, benefiting the qi, drying dampness and harmonising the stomach. In the subsequent research and development process, this project will draw on the concept of "overall regulation" of Chinese medicine, combined with modern metabolic engineering technology, screening the active ingredients of traditional Chinese medicine with the effect of intestinal flora regulation, and incorporate them into the optimisation of the formula of the probiotic capsule, so as to achieve the integration and innovation of "traditional theory + modern technology". "The integration of traditional theory and modern technology. Through the implementation of the project, not only can we develop probiotic products that are more in line with the intestinal characteristics of the Chinese population, but also promote the modernisation of the interpretation of the theory of traditional Chinese medicine, provide a new path for the inheritance and innovation of the national medicine, and enhance China's cultural discourse and technological competitiveness in the field of probiotic bacteria in the world.

1.2.2 Industry position for long-term development

Become a technology leader in the field of intestinal microecology intervention: Currently, the global probiotic market is dominated by traditional probiotics (e.g., single-strain or mixed-strain preparations), and there are pain points such as "unclear mechanism of action, poor targeting, and unstable effect" in the products. The core advantage of this project is to adopt metabolic engineering technology to genetically modify Lactobacillus, introducing key components such as p16090 promoter (responding to intestinal bile acid expression), OLE1 gene (synthesising oleic acid to inhibit harmful bacteria), accA gene (enhancing the expression of oleic acid), and DEFB4A gene (inhibiting inflammatory response), so as to realise the "intelligent response" and "stable effect" of the probiotic bacteria. Intelligent response" and "multi-functional synergy" - in the intestinal specific environment (such as the presence of bile acids) to accurately activate the action, and at the same time to play the inhibition of harmful bacteria, immune regulation, anti-inflammatory multiple efficacy, the technical level is in the international leading position. The technology is in a leading position in the international arena. The project plans to continuously optimise genetic elements, screen for better strains and expand indications through sustained R&D investment (annual R&D expenses account for more than 15% of revenue). It is expected that the project will apply for relevant invention patents within 3-5 years of project implementation, so as to form a complete technological system covering strain modification, dosage form development and clinical application, and become a global leader in the field of intestinal micro-ecological intervention. Become a global technology benchmark in the field of intestinal microecology intervention.

Create a benchmark brand in the field of segmentation, leading the market consumption upgrade: China's probiotic market size has exceeded 80 billion yuan, but the market product homogenisation is serious, and most of the products focus on the basic functions of "laxative", "regulating immunity", etc., and there is a lack of specialised products for the specific groups of people. There is a lack of specialised products for specific groups. The project will initially focus on the market segment of perioperative intestinal flora imbalance, and then gradually expand to chronic digestive diseases and metabolic diseases, forming a "specialised and precise" product matrix. In terms of brand building, the project will take "clinical evidence" as the core, and carry out multi-centre, randomised controlled clinical trials (RCTs) to verify the effectiveness and safety of the products in different populations and accumulate evidence-based medical evidence; at the same time, it will establish cooperation with the gastroenterology department and the surgery department of tertiary hospitals, and promote the products to enter the clinical recommendation catalogue, so as to establish a "clinical-grade probiotic" brand. Meanwhile, we will establish cooperation with the departments of gastroenterology and surgery of tertiary hospitals to promote the product into the clinical recommended catalogue and establish the brand image of "clinical grade probiotics". It is expected that within 5 years of the implementation of the project, the share of the product in the perioperative probiotic market will reach more than 30%, becoming the first brand in the segment; within 10 years of the implementation of the project, it will become one of the top brands in the domestic probiotic market, and will promote the consumer upgrading of the industry from a "mass market product" to a "precise and evidence-based product". To promote the industry from "mass products" to "precise and evidence-based products".

Constructing a collaborative innovation platform of "industry, academia, research and medicine" to promote the formulation of industry standards: The healthy development of the probiotic industry requires the synergy of the whole chain of "basic research - technology research and development - clinical application - standard formulation". This project will build an "industry-university-research-medicine" collaborative innovation platform by combining Lanzhou University (basic research), biopharmaceutical companies (technology transformation), tertiary hospitals (clinical verification) and industry associations (standard setting). At the basic research level, we will carry out research on the association mechanism between intestinal flora and systemic health to provide theoretical support for product development; at the technology transfer level, we will optimise probiotic fermentation process and preparation technology (e.g., enteric coating technology to improve probiotic intestinal survival rate) to reduce production costs; at the clinical application level, we will carry out real-world studies (RWS) to accumulate data on the application of the products to a wide range of people; at the standard-setting level, we will participate in the formulation of the "Metabolism" standard and the "Metabolism" standard. standardisation level, participate in the formulation of industry standards such as the Code of Practice for Quality Management of Metabolically Engineered Probiotics Production and Guidelines for Clinical Application of Probiotics to standardise the development of the industry. It is expected that within 5 years of the project implementation, the platform will become a national innovation platform for intestinal microecology intervention; within 10 years of the implementation, it will lead or participate in the formulation of relevant international standards in the field of probiotics, so as to enhance China's right to formulate rules in the global probiotic industry. 1.2.3 Objectives of the project in promoting the cause of universal digestive health.

Primary goal (1-3 years): Focus on clinical pain points and establish the foundation of product effectiveness.

Core tasks: Complete preclinical studies (e.g., safety evaluation, in vitro efficacy validation) and Phase I/II clinical trials of metabolically engineered probiotic capsules to validate the safety and efficacy of the product in perioperative patients (e.g., reduce the incidence of postoperative intestinal infections and improve the diversity of intestinal flora); at the same time, establish co-operation with 3-5 tertiary hospitals to carry out pilot clinical applications of the product and accumulate preliminary clinical data; In addition, develop a digestive health management manual for perioperative patients and carry out a small-scale science education (covering 100,000 people).

Milestones: the product has obtained clinical trial approval from NMPA and completed Phase I/II clinical trials, proving the effectiveness of the product in regulating perioperative intestinal flora (e.g., shortening the recovery time of postoperative intestinal flora by 20% and reducing the incidence of infections by 15%); the cumulative number of patients in the pilot hospitals has reached more than 500; and the digestive health awareness rate of the population covered by popular education has increased to more than 30%. to more than 30%.

Intermediate target (4-8 years): Expand application scenarios and build a health management system.

Core tasks: complete the phase III clinical trials of the product, obtain the drug approval number and achieve industrial production; expand the application scenarios of the product from the perioperative period to the fields of chronic digestive diseases (e.g., IBS, inflammatory bowel disease), metabolic diseases (e.g., obesity, type 2 diabetes), etc., and develop 2-3 sub-products; collaborate with more than 100 hospitals and more than 200 community health service centres to establish the "Digestive Health Screening - Digestive Health Management System". Cooperate with more than 100 hospitals and 200 community health service centres to establish a whole-process management system of "digestive health screening-intervention-follow-up"; carry out large-scale science education activities (covering 10 million people), and promote the inclusion of digestive health management in primary healthcare services.

Milestones: the product achieves annual sales of 500 million to 1 billion yuan, and its market share in perioperative and chronic digestive disease probiotics reaches 30% and 20% or more, respectively; establish a digestive health management network covering 30 provinces across the country, with a cumulative total of more than 1 million people served; the digestive health literacy rate of the population covered by popular science education is raised to 60% or more, the rate of antibiotic abuse is lowered by 10%, and the rate of dietary Fibre intake rate will be increased by 15%.

Ultimate goal (9-15 years): to lead the development of the industry and achieve digestive health for all.

Core mission: to become a global technology leader and brand leader in the field of intestinal microecology intervention, with products exported to countries along the "Belt and Road" as well as the European and American markets; to build a universal digestive health service system integrating "prevention-intervention-treatment-rehabilitation" and to incorporate the management of digestive health into the national basic public healthcare system. We will incorporate digestive health management into the national basic public health service programme; promote the formulation of the world's leading digestive health-related standards and guidelines, and lead the industry to develop in the direction of "precision, evidence-based and intelligence"; and ultimately achieve a significant improvement in the digestive health literacy of the whole population and a significant reduction in the incidence rate of digestive diseases, so as to contribute to the "Healthy China" campaign. Ultimately, we will achieve a significant improvement in the digestive health literacy of the entire population and a significant reduction in the incidence rate of digestive diseases, providing important support for the realisation of the strategic goal of "Healthy China".

Achievements: the share of our products in the global probiotic market will be among the top ten, and the export value will account for more than 30% of the total sales; the knowledge rate of digestive health literacy of the whole population will be increased to more than 80%, the incidence rate of chronic digestive diseases will be reduced by 20-25%, and the growth rate of the incidence rate of metabolic diseases will be reduced by 20-25%; the technological discourse and the right to formulate rules in the field of global digestive health will be significantly enhanced, and we will become an important contributor to the development of the cause of global digestive health. China's technological discourse and rule-making power in the field of global digestive health has significantly increased, becoming an important contributor to the development of global digestive health.

2 Project Background

2.1 Historical development of the industry

The development of the digestive health industry reflects the interaction of medical advances, changes in the disease spectrum and the evolution of health concepts. The development of China's gastroenterology profession has gone through an arduous process from scratch, from weak to strong. Before the founding of New China, there was basically no professional discipline of gastroenterology in China, and the diagnosis and treatment of digestive diseases lacked systematicity and specialisation. After the founding of the People's Republic of China, the development of gastroenterology has gone through three distinct phases: the founding period from the early period of the founding of the People's Republic of China to the Cultural Revolution, the low-tide period at the time of the Cultural Revolution, and the developmental period from 1978 onwards to the present time [ Pan Guozong. Gastroenterology in China at the turn of the century[J]. Chinese Journal of Gastroenterology,2000,(03):46-50.J].

Founding period (from the early period of the founding of the People's Republic of China to the Cultural Revolution): the core task was to build a basic diagnostic and therapeutic framework. With the initial establishment of the modern medical system, gastroenterology was gradually separated from internal medicine and began to form a professional diagnostic and treatment team. At this time, the focus of the industry was concentrated on "solving urgent medical needs" - targeting highly prevalent infectious diseases such as cholera and typhoid fever, and taking therapeutic drugs as the core products, through the large-scale supply of antibiotics, rehydration preparations, etc., to quickly control the spread of the epidemic. At this stage, the industry was dominated by a handful of state-owned pharmaceutical companies, with "treating diseases" as the only goal of medical treatment, and the concept of "prevention" had not yet entered the public's consciousness, and primary healthcare's ability to intervene in digestive diseases was virtually non-existent.

Low period (Cultural Revolution period): Industry development was stagnant, but there were still local breakthroughs in technology application. Subject to the overall social environment, the construction of disciplines and scientific research progress slowed down, but the clinical demand for "more accurate diagnosis" drove the initial exploration of the device field. Gastroenteroscopy, capsule endoscopy and other screening equipment began to be applied on a small scale, and minimally invasive interventional techniques were tried to be used in the treatment of peptic ulcers, bleeding and other diseases, which not only filled the gaps in diagnostic and therapeutic means at that time, but also more importantly allowed the awareness of early detection of diseases to begin to germinate in some hospitals, which contributed to the transformation of the industry into a "combination of prevention and treatment". "Combination of prevention and treatment" transformation for the subsequent industry to lay the groundwork. At this time, the industry was dominated by leading equipment companies and large general hospitals, while primary healthcare institutions still found it difficult to carry out standardised screening and treatment of digestive diseases due to a lack of resources.

Development period (1978-present): The industry entered the stage of rapid development of "diversification and precision". After the reform and opening up, changes in dietary structure brought about by economic upgrading and mental stress triggered by the accelerated pace of life combined to drive a fundamental shift in the spectrum of digestive diseases - infectious diseases associated with "poverty and poor hygiene" gradually faded away, and diseases caused by "high-fat, high-protein diets" gradually faded away. Instead, infectious diseases associated with "poverty and poor hygiene" have gradually faded out, while "diseases of affluence" (e.g., gastroesophageal reflux, fatty liver, colorectal cancer) and functional gastrointestinal disorders (e.g., irritable bowel syndrome) triggered by "high-fat, high-protein diets, sedentary lifestyles, and mental anxiety" have become the mainstream. This change has directly pushed the industry to shift from "treatment-oriented" to "both prevention and treatment", and the product form has expanded from a single drug to "probiotics, digestive enzymes, dietary fibre" and other At the same time, digital tools such as intestinal flora testing, AI-assisted diagnosis, and remote management have been integrated into the diagnosis and treatment process to achieve the synergy of "in-hospital diagnosis and treatment + out-of-hospital management".

Stage	Time	Market/Product	Policies ＆Events	Patterns ＆ Impacts
Treatment-oriented	Early National Period to the Cultural Revolution	Therapeutic drug-based	Construction of Modern Diagnosis and Treatment System	Pharmaceutical companies dominate, focusing on treatment but not prevention
Instruments and Screening	during the Cultural Revolution	Gastroenteroscopy, Capsule Endoscopy, Minimally Invasive Intervention	Promotion of primary speciality construction	Leading equipment companies and general hospitals dominate, awareness of screening is emerging
Prevention and numbers	1978 onwards to the present	Probiotics / Digestive Enzymes / Dietary Fibre; Gut Flora Testing, AI Assisted Diagnosis, Remote Management	Healthy China 2030; OTC and Consumer Grade Penetration Increase	In-hospital and out-of-hospital synergy, new forces account for an increased proportion

At the same time, people's awareness of gastrointestinal health is also increasing, and their spending power in this area is also rising. In terms of consumer awareness and market landscape, the industry has undergone three key transformations:

Traditional tonic stage (1980s): Health demand remained at the level of "basic nutritional supplementation". Restricted by the economic level and health awareness, consumers' understanding of digestive health was only "relief of gastrointestinal discomfort", and the market was dominated by natural nutrients such as honey and jujubes, with a single product category and a lack of scientific efficacy verification system. At this time, local brands are just starting out, the regulatory system is in the initial stage of establishment, the market order is based on "quality compliance" as the minimum requirements, and has not yet formed a differentiated competitive landscape.

Nutrition and basic probiotics stage (1990s): health needs escalated to "targeted nutritional supplementation". With the improvement of national living standards, consumers began to pay attention to the role of vitamins, minerals and other basic nutrients to support the digestive function, and at the same time, the concept of probiotics was introduced from abroad, and basic probiotic products (e.g., single-strain yoghurt, ordinary live bacteria preparations) began to enter the market. Foreign-funded enterprises quickly seized the market by virtue of technological advantages and brand influence, while local enterprises participated in the competition through imitation and low-priced strategy to promote the rapid expansion of the market scale. However, at this time, the products mostly stayed at the level of "broad-spectrum conditioning" and lacked the targeted design for specific populations and scenarios, and the focus of the competition was concentrated on the "price and channel". The focus of competition is concentrated on "price and channels" rather than "efficacy and technology".

Functional segmentation and digital management stage (2000s to present): Health demand has entered the stage of "personalisation and precision". Consumers' perception of digestive health is no longer limited to "symptom relief", but rather the pursuit of "long-term maintenance of intestinal micro-ecological balance", which drives the development of products in the direction of functional segmentation - targeting Constipation, diarrhoea, irritable bowel syndrome and other specific problems of probiotic preparations, combined with digestive enzymes and dietary fibre compound formula products continue to emerge. At the same time, policy support for the health industry has increased, the penetration of OTC channels and consumer health platforms has moved digestive health products from "medical scenarios" to "daily consumption scenarios", and the application of digital tools (e.g., intestinal flora testing APP, AI health consulting) has further enabled the development of digestive health products. The application of digital tools (e.g. intestinal flora testing APP, AI health consulting) further realises the whole-process management of "testing-intervention-follow-up", and the industry pattern has gradually shifted from "dominated by foreign investors" to "competition between local new forces and foreign investors". The industry landscape has gradually shifted from "foreign domination" to "local new forces competing with foreign ones", and new enterprises are continuously increasing their market share by virtue of their accurate grasp of local consumers' needs and digital service capabilities.

Stage	Duration	Category	Regulation and Channels	Pattern and Impact
Traditional Tonic	1980s	Honey, dates, goji berries and other supplements	Gradual establishment of regulatory system	Local brands start with a single category
Nutrition & Basic Probiotics	1990s	Vitamins/minerals, basic probiotics	Influx of foreign and local enterprises	Competition intensifies as market expands
Functional Segmentation & Number Management	2000s to present	Probiotics, digestive enzymes, and other categories have increased	Policy support for health industry	Deepening segmentation and rise of digital services

2.2 Development Trend Forecast

2.2.1 Policy guidance and regulatory environment

The influence of policies on the digestive health industry is shifting from "macro-guidance" to "fine specification and precise support", forming a multi-level policy system of "national strategic leadership, local practice, and industry standard improvement". The formation of a multi-level policy system of "national strategy leadership, local practice landing, industry standard improvement", for the development of the industry to delineate a clear direction and boundaries.

At the national level, the core logic of the policy is to "incorporate digestive health into the national chronic disease prevention and control system", and to promote the industry to "standardisation and high quality" through top-level design. The introduction of the "Guidelines for Establishing Price Items for Digestive Healthcare Services (Trial)" is not a simple price adjustment, but the establishment of a "clear classification, reasonable pricing" through the mapping and consolidation of the current price items into 150 items, 69 items for additional charges, and 16 items for extensions [ https://www.nhsa.gov.cn/art/2025/8/21/art_14_17652.html ]. "This not only avoids the confusion of pricing of digestive medical services in different regions and hospitals, reduces the burden on patients, but also provides a clear price basis for medical institutions to carry out innovative services such as intestinal flora testing and microecological intervention, and encourages medical institutions to develop innovative services such as intestinal flora testing and microecological intervention. This not only avoids the confusion of pricing for digestive medical services in different regions and hospitals, but also reduces the burden on patients, and provides a clear price basis for medical institutions to carry out innovative services such as intestinal flora testing and microecological intervention, which encourages hospitals to incorporate more innovative technologies into clinical pathways. At the same time, the "Healthy China 2030" planning outline clearly put forward the microecological balance is the key path of chronic disease prevention and control and immunity enhancement, intestinal health has been mentioned at the national strategic level. Previously, the "13th Five-Year Plan" national key research and development programme has carried out research related to the health functions of probiotics, laying a solid foundation for the development of the intestinal microecology industry. These policies have created a favourable development environment for the digestive health industry.

At the local level, the policy focuses on the "landedness and universality", activating regional market demand through specific projects. Take Harbin City's free testing programme for digestive tumours and the "four highs" as an example, which provides colorectal cancer (faecal DNA methylation), gastric cancer (Helicobacter pylori) and the "four highs" for residents aged 45-64 years old [ ]. http://www.hlj.xinhuanet.com/20250912/03226da9ff884adfadbdde33700a8523/c.html]. The value of this type of project lies not only in the "early detection and treatment" of diseases, but also in the cultivation of public awareness of digestive health screening - through the provision of free non-invasive screening services such as faecal DNA methylation testing and H. pylori testing, the public will be able to "check their gut health regularly". Through the provision of free non-invasive screening services such as faecal DNA methylation testing and H. pylori testing, "regular intestinal health check" has become a habit for residents, which in turn drives the demand for subsequent health intervention products. At the same time, through cooperation with enterprises, local governments combine testing services with product interventions (e.g., probiotics, nutritional preparations) to form a closed loop of "testing-assessment-intervention", which not only creates stable market demand for enterprises, but also transforms the policy dividend into a real benefit for the health of the entire population.

In the future, there will be two major trends in the regulatory environment: first, the gradual improvement of the classification and regulatory system - for probiotics, intestinal flora testing and other products, to clarify the classification criteria of "medical-grade" and "consumer-grade", to avoid enterprises from "medical-grade" and "consumer-grade" products. The first trend is the gradual improvement of the classification and regulation system - clarifying the classification standards of "medical grade" and "consumer grade" for products such as probiotics and intestinal flora tests, so as to prevent enterprises from "confusing the concepts and exaggerating the efficacy". Establishment of "clinical data filing system" and "adverse reaction monitoring system" to protect consumers' rights and interests and promote the industry from "barbaric growth" to "healthy and orderly development". orderly development".

2.2.2 Changes in consumer demand

The change of consumer demand is the core driving force to promote the transformation of the digestive health industry from "scale expansion" to "quality improvement", and the current change of demand presents three major features, namely "upgrading of concepts, improvement of standards and segmentation of scenes". "The current changes in demand show three major characteristics, which profoundly affect the industry's product design and market strategy.

The popularity of the concept of "prevention first" has completely reconstructed consumers' cognitive framework of digestive health. In the past, consumers' concern for digestive health mostly started with the "appearance of symptoms" (such as stomach pain and diarrhoea), and the demand at this time was "quick relief of discomfort"; now, with the deepening of the knowledge of the "association between intestinal microecology and systemic health", consumers have become more and more aware of the importance of preventive health. Now, with the deepening awareness of "the link between intestinal microecology and systemic health", consumers are beginning to regard digestive health as "the foundation of systemic health", and the demand has shifted from "passive treatment" to "active prevention". --They are no longer satisfied with "solving the current problem", but hope to avoid the risk of chronic diseases (e.g. fatty liver, cardiovascular disease) in the future through long-term and continuous intervention (e.g. daily probiotic supplementation, regular intestinal flora testing). This shift in philosophy has pushed the market from "symptom-oriented products" (e.g. anti-diarrhoeal drugs, stomach pills) to "long-term management products" (e.g. daily probiotics, dietary fibre supplements), and has also required companies to provide "test-assessment-intervention-follow-up" (e.g. daily probiotics, regular testing of intestinal flora). Meanwhile, companies are also required to provide a full-cycle service of "test-assessment-intervention-follow-up" rather than a single product.

Consumers' demand for "effectiveness and safety" has forced the industry to shift from "marketing-driven" to "research-driven". In the past, some companies seized the market through exaggerated publicity (e.g. "cure constipation", "boost immunity") and low-priced promotions, which led consumers to question the effectiveness of the products; nowadays, consumers are more concerned about the "scientific basis" when choosing digestive health products. Nowadays, when choosing digestive health products, consumers are more concerned about the "scientific basis", i.e. whether there is clinical research data to support the efficacy of the product, whether the survival rate of the strain has been verified by a third party, and whether there are potential side effects. This change in demand has led to the gradual elimination of products with "no clinical validation and ambiguous efficacy" from the market, while products with clear scientific research endorsement (e.g., university co-operation in R&D, certification by authoritative organisations), and quantifiable effects (e.g., "improves regularity of defecation in 7 days") have been eliminated from the market. Products with clear scientific backing (e.g., research and development by universities, certification by authorities) and quantifiable effects (e.g., "improves bowel regularity in 7 days", "reduces the proportion of harmful intestinal bacteria") are more popular. Meanwhile, consumers' preference for "natural and additive-free" products has also pushed companies to reduce preservatives, sweeteners and other ingredients in their formulations, and shift to safer natural ingredients and processes.

Personalisation and diversification of demand have pushed the market into the stage of "precise segmentation". The demand for digestive health products is significantly different among different groups of people due to differences in age, living habits, and health conditions: white-collar women in first- and second-tier cities face the problems of "sedentary lifestyle, takeaway diets, and high mental stress", and demand is focused on "convenient and efficient" products. The demand focuses on "convenient and efficient" product forms (e.g. ready-to-drink probiotics, portable capsules), as well as the synergistic effect of the products on the skin condition and endocrine system; the elderly group, due to the decline of intestinal function, needs mild products for constipation and irritable bowel syndrome, and has high demands on the convenience of the products (e.g. easy to swallow, no need for refrigeration); the maternal group is concerned about the effect of the products on the fetal intestinal tract. Pregnant women, on the other hand, are concerned about the impact of the product on the intestinal health of the foetus, and prefer probiotic preparations that are antibiotic-free and have been proven to be safe during pregnancy. This segmented demand not only gives rise to more targeted products, but also pushes companies to shift from "mass production" to "flexible customisation", and enhance user stickiness by providing personalised health solutions (e.g. recommending exclusive strains based on the results of intestinal flora tests).

2.2.3 Technological innovation and product upgrading

Technological innovation is the core driving force for the development of the digestive health industry. At present, the industry is undergoing transformation and upgrading from traditional products to high-tech content products. In the field of probiotics, technological innovation mainly focuses on improving the survival rate and colonisation efficiency of bacterial strains. For example, GUTX has developed the "Dual-Compartment Fresh" technology, which ensures that the probiotics maintain the best active state before drinking through the powder-liquid separation design, and the probiotics are quickly awakened and enter the intestinal tract in the freshest state through one-click mixing. http://www.chinadevelopment.com.cn/zxsd/2025/0818/ 1956669.shtml].

Formulation innovation is also an important direction: BEE+ Stomach Shield adopts the "three-stage golden stomach formula" formed by Manuka honey, curcumin and sea buckthorn, which eliminates the cause of disease, anti-inflammatory repair and consolidation of protection as the underlying logic, to achieve the long-term maintenance of the gastrointestinal barrier in the whole chain. The product also uses patented ultra-micron import technology to micronise ingredients such as curcumin, which can be rapidly absorbed without physical digestion and improve bioavailability.

Advances in diagnostic and monitoring technology have also provided new opportunities for industry development. The free digestive tumour testing programme in Harbin City uses faecal DNA methylation testing to assess the risk of colorectal cancer and progressive adenomas through faecal testing. This non-invasive testing technology is simple to operate and suitable for early screening of large-scale asymptomatic people, helping to achieve early detection and treatment of digestive system diseases.

In the future, with the in-depth integration of artificial intelligence and big data technologies, the digestive health industry will enter the era of "personalised and precise management", where AI-driven intestinal biological research and development platforms can analyse massive amounts of intestinal flora data to quickly screen out the optimal strains of bacteria for specific diseases (e.g., obesity, type 2 diabetes), and big data can integrate the user's diet, exercise, sleep, etc., to provide the best possible results. Big data can integrate the user's diet, exercise, sleep and other habits data to build a personalised intestinal health model and dynamically adjust the intervention programme. This "technology + data" model will completely change the traditional product logic of "a thousand people on one side", provide consumers with "tailor-made" digestive health solutions, and promote the industry from "product sales" to "product sales". From "product sales" to "health service" transformation.

3 Product Overview

3.1 Product Overview

3.1.1 Core Positioning

This product is a medical-grade metabolically engineered probiotic capsule that deeply integrates synthetic biology technology and clinical medical needs. Its core positioning focuses on "perioperative digestive micro-ecological balance expert", aiming to break through the limitations of traditional digestive health products, such as "generalised conditioning and weak scene adaptation". It aims to break through the limitations of traditional digestive health products of "generalised conditioning and weak adaptability to scenarios", and accurately solve the imbalance of intestinal flora of perioperative people due to special factors such as surgical trauma, use of antibiotics, and fasting stress, etc., and at the same time, it provides layered solutions for people with different health needs - not only to satisfy the "reduce It not only meets the medical needs of perioperative patients to "reduce the risk of complications and accelerate the recovery of intestinal function", but also covers the consumer needs of middle-aged and young people with subhealthy intestines for "daily maintenance and prevention of potential intestinal problems", and ultimately builds a product positioning system of "entry in the medical scenario and extension in the consumer scenario". Eventually, it will build a product positioning system of "medical scene entry and consumer scene extension" to fill the gap of intestinal health management products in the clinical field for the special physiological state of surgery.

3.1.2 Technical basis and core components

The product takes Lactobacillus as the chassis strain, and constructs the technical architecture of "precise response, functional synergy, safety and control" through systematic genetic engineering modification, and the design of the four key functional components does not work in isolation, but forms a mutually supportive technological closed loop:

p16090 promoter: as a "precise positioning switch", its core value is to realise the "spatial and temporal specificity" of the strain's action - it is only activated in the bile salt environment in the intestine. Its core value is to achieve the "spatio-temporal specificity" of the strain's action - activating only in the bile salts environment of the intestine, avoiding the activation of the strain in the oesophagus, stomach and other non-target sites, which not only reduces the metabolic burden of the non-essential sites and the potential side effects, but also ensures that the strain focuses on the core scenario of perioperative intestinal disorders, solving the problem of the traditional probiotic bacteria, "ambiguous site of action and dispersed active ingredients";

OLE1 gene and accA gene: constitute the "twin engines of harmful bacteria inhibition", OLE1 gene is responsible for the synthesis of oleic acid, a key bacterial inhibitor, while accA gene significantly improves the synthesis efficiency and secretion of oleic acid through enhanced metabolic pathway regulation, forming a "synthesis-enhanced" synergistic mechanism, targeting the perioperative intestinal disorders. The synergistic mechanism of "synthesis-enhancement" can achieve targeted inhibition of the perioperative overgrowth of harmful bacteria in the intestinal tract, rather than indiscriminate regulation of the intestinal flora;

DEFB4A gene: It undertakes the function of "immune repair and mucosal protection". During the perioperative period, the intestinal tract not only faces the imbalance of bacterial flora, but also accompanied by the damage of mucosal barrier and inflammatory reaction, this gene can regulate the activity of gut-associated lymphatic tissues (GALT), reduce the level of inflammatory factors, and simultaneously inhibit harmful bacteria at the same time. By regulating the activity of intestinal lymphoid tissue (GALT) and reducing the level of inflammatory factors, the gene can simultaneously repair the physical and immune barriers of the intestinal tract while "inhibiting harmful bacteria", forming a dual intervention of "bacterial regulation + tissue repair", avoiding the limitation of traditional products that "only regulate the bacterial flora, but do not repair the damage".

In addition, the safety design of strains is carried out throughout the whole process of technology development, from the screening of chassis strains (selecting Lactobacillus strains with high homology and proven safety in human body), to the source of gene components (giving priority to the use of human intestinal commensal bacteria with homologous gene fragments), to the controllability of expression control (to ensure that the intensity of gene expression is suitable for the intestinal environment, to avoid the accumulation of excessive metabolite products), have gone through several rounds of safety assessment. This ensures the compliant application of the product in medical scenarios.

3.1.3 Applicable Population and Scenarios

The classification of the product's population and scenarios is not based on simple demographic classification, but is stratified by combining the "intensity of health needs + physiological state specificity + scenario use logic":

(1) Core target group: perioperative patients

Focusing on gastrointestinal surgery, major orthopedic surgery, and oncology surgery, the intestinal microecology of this group is facing a "triple impact" - the stress caused by surgical trauma will destroy the integrity of the intestinal mucosal barrier, and the use of antibiotics will indiscriminately kill harmful bacteria and beneficial bacteria, and preoperative fasting will kill harmful bacteria and beneficial bacteria. The use of antibiotics will indiscriminately kill harmful bacteria and beneficial bacteria, and preoperative fasting will lead to a lack of nutrient supply to the intestinal flora, and the superposition of the three makes the incidence of intestinal bacterial imbalance significantly higher, which in turn induces postoperative infections, intestinal paralysis, nutrient absorption disorders and other complications. The core value of the product for this group of people lies in the full-cycle intervention of "optimising the bacterial structure before surgery, maintaining the bacterial homeostasis during surgery and accelerating the recovery of the bacterial flora after surgery", which is suitable for the clinical "accelerated recovery in perioperative period (ERAS)" system, and it has become an innovative auxiliary tool for the doctors in the It has become an innovative aid for doctors in the management of intestinal tract.

(2) Expanding the target population

Middle-aged and elderly patients with chronic digestive diseases (e.g. irritable bowel syndrome (IBS), inflammatory bowel disease (IBD)): the imbalance of intestinal flora in this group of people has the characteristics of "long-term and recurring", and the product can continuously regulate the metabolism of bacterial flora, inhibit chronic low-grade inflammation, and provide "non-drug intervention supplementation" for the management of diseases, and reduce the need for traditional intestinal management. The product can provide "non-pharmacological intervention" for disease management by continuously regulating bacterial metabolism and inhibiting chronic low-grade inflammation, reducing the dependence on traditional medication and the side effects of long-term medication;

Young and middle-aged intestinal sub-healthy people: this group of people due to irregular diet, work pressure, sedentary habits, often bloating, constipation, intestinal sensitivity and other problems, and some people have potential surgical needs (such as physical examination found that intestinal polyps need to be resected at an elective stage), the product can be taken on a daily basis to maintain the balance of intestinal flora, not only to alleviate the symptoms of sub-health at the moment, and also for the possible future surgery in advance of the reserves of intestinal health. The product can be taken daily to maintain the balance of intestinal flora, not only to relieve the symptoms of sub-health, but also to reserve intestinal health in advance for possible future surgeries.

3.2.2 Collaborative services on the medical side

The product is not an isolated medical support tool, but through deep synergy with the medical system, it is integrated into the clinical diagnosis and treatment process, forming a closed loop of value on the medical side of "product+service+data":

Clinical Support Services: Enabling Medical Practice

Provide full-process clinical support for partner hospitals (with the gastroenterology and surgery departments of tertiary hospitals as the core) - carry out preoperative training on the application of the product, make clear the screening criteria for applicable patients (e.g., exclude contraindications such as severe immune deficiencies, intestinal obstruction, etc.), and the key points of the timing of the administration and the control of the dosage; provide free bacterial colony detection equipment and technical support during the operation. Provide free bacterial flora testing equipment and technical support during the operation to help doctors monitor the dynamic changes of patients' intestinal flora in real time; jointly carry out clinical research after the operation, collect data on the correlation between the product and the incidence of postoperative complications, length of hospitalisation and quality of recovery, publish academic papers and formulate consensus on the clinical application of the product, upgrading the product from a "single product" to a "clinical research tool", and enhancing doctors' confidence in the product. This upgrades the product from a "single product" to a "clinical research tool" and enhances doctors' trust and willingness to use the product.

Data sharing service: help medical decision-making. Build a "regional intestinal microecology database", integrate the information provided by the partner hospitals on the type of surgery, pre-operative and post-operative bacterial flora data, and the effect of product use, etc., and analyse the intestinal health trends in the region (e.g., the types of common bacterial imbalance in patients of gastrointestinal surgery in a certain region, and the correlation between the high incidence of post-operative infections and bacterial flora characteristics), and provide data support for hospitals to optimize the clinical pathway. Provide data support for the optimisation of clinical pathways - for example, to assist doctors in formulating a standardised pre-operative bowel management plan for common flora imbalance problems in certain types of surgical patients, to reduce fluctuations in the management effect due to differences in individual experience, and at the same time to accumulate clinical data for the subsequent iteration of the product (e.g., optimising the formulation of the strains for specific types of surgeries).

3.2.3 Public welfare and education services

The service system of the product not only covers the direct users, but also extends to the field of public health, achieving synergy between commercial value and social value through "public welfare empowering health equity and education popularising health awareness":

(1) Public health services: solving the pain points of intestinal health of disadvantaged groups

The "Beneficial Bowel Journey" public welfare project is not a simple product donation, but a public welfare ecology of "detection-intervention-empowerment" - through the mobile micro-ecological diagnostic and treatment vehicle, to provide healthcare services for children, pregnant women, the elderly, the elderly, the elderly, the elderly, the disabled, the elderly, the elderly, the disabled and the disabled. Through the mobile micro-ecological diagnostic vehicle, the project provides free intestinal flora testing and product interventions for children, pregnant women and the elderly with chronic diseases, and at the same time provides customised guidance to address the health pain points of different groups (e.g., designing an intestinal care programme adapted to the diet of the canteen for children in boarding schools, and providing advice on the maintenance of the flora during pregnancy and prevention of intestinal health in preterm babies); setting up demonstration stations of digestive health in villages, which not only provide product pick-up and health consultation services, but also help optimise the local agricultural cultivation structure. In addition to providing product collection and health consultation services, the company also helps optimise crop selection (such as promoting high oleic acid crops) in accordance with the local planting structure of agricultural products, so as to improve intestinal health from the source of nutritional intake, thus realising the dual value of "health public welfare and industrial support".

(2) Education and popularisation services: building a national intestinal health awareness system.

The education service focuses on "layered popularisation of science and scenario-based dissemination", avoiding the problem of "one-way instillation and boring content" of traditional popularisation of science: for the public, through the series of contents of "Intestinal Adventure" (short videos, meta-universe games), we will provide the public with a series of educational services. For the public, through the "Intestinal Adventure" series of contents (short videos, meta-universe games), the abstract knowledge of intestinal microecology is transformed into perceptible scenes; for the campus, the "Intestinal Health Credit System" is not purely curriculum teaching, but through three-dimensional folding pages, bacterial strain cultivation experiments, and other interactive forms, so that students can understand the correlation between intestinal function and health in practice, and at the same time, the family sharing tasks are incorporated into the credit system, promoting the "intestinal health" and "intestinal health". At the same time, family sharing tasks are incorporated into the credit system to promote the dissemination of health knowledge through "one student leads one family". For medical and healthcare practitioners, the Probiotics Evidence-Based Education Centre provides continuing education courses that cover not only product knowledge, but also cutting-edge research, clinical application case studies, and case studies in the field of intestinal microecology. For medical and health practitioners, the Centre provides continuing education courses that not only cover product knowledge, but also include cutting-edge research and clinical application case studies in the field of intestinal microecology, helping practitioners to update their knowledge system and enhance their professional ability in intestinal health management.

3.3 Product Characterisation

3.3.1 Technical differentiation: precision and multifunctional synergy

(1) Targeted technology breakthrough

The core limitation of traditional probiotics lies in the "lack of specificity" - after entering the human body, the strains may start to metabolise in non-target areas such as the oesophagus and stomach, resulting in an insufficient number of effective strains in the intestinal tract, and causing discomfort in non-essential areas (e.g., bloating due to overpopulation of bacteria in the stomach). The p16090 promoter can be used in a variety of ways, including) The p16090 promoter design of this product is essentially an "intestinal localisation system" for the strain, which is activated and expressed only in the intestinal bile salts environment, ensuring that the strain's energy and metabolites are focused on the intestinal imbalance, which not only improves the efficiency of action, but also reduces potential side effects, especially suitable for perioperative patients with sensitive digestive system. (2) Multi-effective and synergistic intervention

(2) Multi-synergistic intervention logic

The functional design of the product is not a simple superimposition of "anti-bacterial + anti-inflammatory" effects, but a "progressive intervention" based on the pathological mechanism of perioperative intestinal damage - first through the OLE1 gene and the accA gene. Firstly, through the OLE1 gene and accA gene to synthesize and strengthen oleic acid, it can rapidly inhibit the overpopulation of harmful bacteria due to the use of antibiotics, and curb the deterioration of the imbalance of bacterial flora; secondly, through the DEFB4A gene to regulate intestinal immune response, repair the mucous barrier damaged by surgical trauma, and reduce the risk of systemic inflammation caused by the entry of endotoxin into the bloodstream; lastly, the bacterial strain, after colonization of the intestinal tract, can regulate the structure of the intestinal flora and promote the beneficial bacterial Finally, after colonisation in the intestinal tract, the strain can regulate the intestinal flora structure through metabolites and promote the proliferation of beneficial bacteria, forming a complete intervention chain of "inhibition-repair-reconstruction", which is more in line with the complexity of intestinal problems in perioperative period compared with the "single-function intervention" of traditional products.

3.3.2 Scenario Differentiation: Focusing on Medical Gap Areas

The intestinal environment of the perioperative population is fundamentally different from that of the general population - preoperative fasting leads to a lack of nutrients in the intestinal flora, intraoperative traumatic stress leads to intestinal mucosal ischemia, and the use of postoperative antibiotics disrupts the balance of the bacterial flora, these special physiological conditions make it difficult for traditional probiotics to survive and their effects are diminished. The product is optimized for these pain points from dosage form to formulation: enteric coating technology ensures that the survival rate of the strain is increased when it passes through the gastric acid environment, so as to avoid being killed by the gastric acid; antibiotic-resistant gene modification allows the strain to maintain its activity during the postoperative antibiotic treatment, so that it is not inhibited by the drugs; at the same time, the product's dosage regimen is designed to be bound to the surgical process in depth (e.g., the product is taken 3 days before the surgery to optimize the bacterial flora in advance and the dosage is adjusted according to the recovery of the intestinal function after surgery). At the same time, the product's dosage programme is designed to be deeply tied to the surgical process (e.g. start taking the product 3 days before surgery to optimize the bacterial flora in advance, and adjust the dosage after surgery according to the recovery of intestinal function), so that the product becomes an integral part of the clinical diagnostic and treatment process rather than an "additional health product".

Linkage and integration of medical and consumer scenarios

The product breaks through the boundaries of "medical products are only for clinical use and consumer products are only for daily use", and builds a scenario linkage mechanism - perioperative patients can gradually transition from medical-grade dosage to consumer-grade daily maintenance dosage according to the intestinal recovery during the post-operative recovery period, realising "post-operative recovery - daily maintenance dosage". During the post-operative recovery period, peri-operative patients can gradually switch from medical-grade dosage to consumer-grade daily maintenance dosage according to their intestinal recovery condition to achieve a seamless transition from "post-operative recovery to daily prevention"; and if consumer-grade users need to undergo surgery, they can rely on the intestinal health data they have accumulated over a long period of time to provide reference for doctors to formulate a pre-operative intestinal management plan to reduce the time and risk of pre-operative preparation. This kind of scenario linkage not only enhances user stickiness, but also makes the product become a "long-term partner" of the user's whole life cycle intestinal health management.

3.3.3 Value Differentiation: Dual Driving of Medical and Social Value

(1) Multi-dimensional embodiment of medical value

The value of the product to the medical system not only lies in "reducing postoperative complications", but also in optimising the allocation of medical resources - by reducing postoperative infections, intestinal paralysis and other complications, it can shorten the length of hospital stay of the patients and alleviate the pressure on hospital beds; at the same time, it can reduce the costs of secondary treatments caused by complications, and reduce the burden on medical insurance funds and individual medical care. At the same time, it reduces patients' secondary treatment costs due to complications, alleviating the burden on the health insurance fund and individual medical care; in addition, the intestinal microecology data accumulated by the product can help hospitals build "perioperative intestinal health management standards", enhance the homogeneity of regional medical services, and promote the transition from "empirical medical care" to "precision medical care". and promote the transition from "empirical medicine" to "precision medicine".

(2) Deep extension of social value

The social value of the product goes beyond the scope of traditional commercial products, and is reflected at three levels: firstly, it promotes the popularisation of digestive health knowledge, and improves the public's misconceptions of "focusing on treatment rather than prevention" and "focusing on symptoms rather than mechanisms" through public welfare and education services, so as to enhance the digestive health literacy of the whole population; secondly, it is to improve the quality of digestive health of the whole population. The second is to help "Healthy China 2030" chronic disease prevention and control strategy, through the regulation of intestinal flora metabolism, to provide a new path for the prevention of obesity, type 2 diabetes and other chronic diseases, to reduce the pressure of chronic diseases on the public health system; the third is to promote the integration of traditional Chinese medicine and modern biotechnology, drawing on the "holistic management" of traditional Chinese medicine. Thirdly, we will promote the integration of Chinese medicine and modern biotechnology, and optimize the product formula based on the concept of "holistic management" of Chinese medicine, so that the theory of Chinese medicine can be verified and inherited in modern technology, and provide a "traditional + modern" integration paradigm for the innovation of national medicine, so as to enhance China's technological discourse and cultural influence in the field of probiotic bacteria in the world. Influence.

3.4 SWOT Analysis

3.4.1 Strengths

(A) High technological barriers and significant differentiation

(1) Systematic and complete technical structure

The technological advantage of the product is not the innovation of a single gene element, but the construction of a complete technological system of "target identification - functional design - safety control - scene adaptation". From the "precise positioning" of p16090 promoter, to the "bacteriostatic reinforcement" of OLE1 and accA genes, to the "immune repair" of DEFB4A gene, the technical modules form a logical closed loop. The design of each module is based on the physiological characteristics of the perioperative intestinal tract - for example, optimising the promoter response threshold for changes in bile salt concentration in the intestinal tract before and after surgery, and adjusting the efficiency of oleic acid synthesis according to the types of harmful bacteria commonly found in the perioperative period. This systematic design makes the technology difficult to be fragmented and copied, forming deep technical barriers and avoiding rapid catch-up by peers through single technology imitation.

(2) Deep coupling of clinical needs and technology design

The technology development of the product is not "technology oriented", but takes clinical pain points as the starting point -- through in-depth communication with surgeons and gastroenterologists in tertiary hospitals, the core needs of perioperative intestinal management are clarified (e.g., "fast inhibition of harmful bacteria, avoid systemic side effects, and adapt antibiotic therapy"), and then design a targeted technical solution. For example, traditional probiotics are unable to tolerate antibiotics, making it difficult to play a role during post-operative antibiotic treatment, and the product solves this practical clinical problem through antibiotic-resistant gene modification; at the same time, the technical design takes full account of the convenience of clinical use, such as capsule dosage form adapted to the patient's postoperative swallowing ability, and the taking programme is synchronised with the surgical process, reducing the operating costs of healthcare personnel. This "clinical demand-driven technology development" model makes the product more acceptable when entering the medical scene, forming a positive "technology-clinical" cycle.

(B) Collaboration between industry, academia, research and medicine with sufficient resource support

(1) Multi-body synergistic innovation ecology

The collaborative innovation platform of "universities (Lanzhou University) + enterprises (biopharmaceutical companies) + hospitals (tertiary hospitals) + industry associations" built by the product is not a simple form of cooperation, but the formation of an ecological system with a clear division of labour and shared benefits: universities are responsible for Universities are responsible for basic research (e.g. the association mechanism between intestinal flora and systemic health, functional verification of genetic elements), which provides theoretical support for product R&D; enterprises are responsible for technological transformation (e.g. optimisation of fermentation process, development of dosage form, large-scale production), which solves the problem of "laboratory technology to industrialisation"; hospitals carry out clinical verification (e.g. Phase Ⅰ/Ⅱ/Ⅲ clinical trials, real-world clinical trials, and real-world clinical trials). Hospitals carry out clinical validation (such as Ⅰ / Ⅱ / Ⅲ clinical trials, real-world studies) to provide clinical evidence for the effectiveness and safety of the products; industry associations participate in the formulation of standards and promote the products to comply with industry norms. This multi-body synergy model integrates the resources of the whole chain of basic research, technology transformation, clinical application, and standard formulation, avoiding the resource shortcomings of a single body in R&D, production, and validation, and accelerating the process of product commercialisation.

(2) Dual support of clinical and academic endorsement

The resource advantage of the product not only lies in the "cooperation", but also in the "high quality of cooperation" - the joint Lanzhou University in the field of microbiology, synthetic biology has a deep research accumulation, providing academic endorsement for the product technology development. The joint tertiary hospitals (e.g. the National Clinical Medical Center for Digestive Diseases of Peking Union Medical College and West China, which we plan to cooperate with) are authoritative institutions in the field of gastroenterology in China, and the clinical trial data they carry out have high credibility, which can significantly enhance the recognition of the product in the medical community; at the same time, by publishing academic papers and formulating clinical guidelines jointly with these institutions, the product can be transformed from a "commercial product" to a "commercial product". At the same time, by jointly publishing academic papers with these organisations and formulating clinical guidelines, the product can be upgraded from a "commercial product" to an "academically-recognised clinical tool", which will further strengthen its market competitiveness, especially in terms of entering the hospital prescription system and gaining support from the medical insurance policy.

(C) Double benefits of policy and market demand

(1) Accurate matching of policy orientation

The development direction of the product and a number of national policies to form a deep fit, not simply "rubbing the policy hot spots" - "Healthy China 2030" programme will be Chronic disease prevention and control" and "micro-ecological balance" as a key direction, the product through the regulation of intestinal flora to prevent chronic diseases, assisting in perioperative rehabilitation, a direct response to this policy demand; the National Health Protection Bureau issued the "digestive system medical service price project The "Guidelines for Establishing Projects" issued by the National Healthcare Security Bureau regulates the price of digestive system medical services, which provides a price policy basis for the product to enter the medical service system; the free digestive system tumour testing project carried out by the local government not only raises the public's attention to intestinal health, but also creates a "testing-intervention" scenario for the product. This precise match of "policy demand - product value" gives the product a natural advantage in market promotion and policy support, and reduces the risk of policy uncertainty.

(2) Structural dividend of market demand

The growth of the global and domestic digestive health market is not a simple scale expansion, but a structural change of "consumption upgrade + release of medical needs" - on the one hand, the public's knowledge of intestinal health has been upgraded from "solving constipation and diarrhoea" to "solving the problem of constipation and diarrhoea". On the one hand, the public's perception of intestinal health has upgraded from "solving constipation and diarrhoea" to "related to systemic health and prevention of chronic diseases", and they are willing to pay a premium for "accurate and effective" products; on the other hand, with the development of surgical technology and the increase in the volume of surgeries, the immediate medical needs of perioperative intestinal management have become increasingly prominent. On the other hand, with the development of surgical technology and the growth of surgical volume, perioperative intestinal management has become an increasingly prominent medical need, and traditional products are unable to meet this niche demand, creating a gap in the market. The product accurately cuts into this "high demand, low competition" market segment, not only can rely on the rigid demand of the medical scene to quickly achieve commercialisation, but also expand the market space with the trend of consumer upgrading, forming a market pattern of "rigid medical needs to protect the base, and consumer upgrading to promote growth". The market pattern of "medical rigid demand to protect the base, consumption upgrade to promote growth" is formed.

3.4.2 Weaknesses

(i) High R&D and production costs

(1) Long-term and continuous R&D investment

Product R&D is not a "one-time investment", but requires continuous investment in capital and manpower - in the technology R&D stage, it is necessary to continuously optimise genetic elements (e.g., improve promoter response sensitivity, enhance bacterial strain colonisation ability), and carry out multiple rounds of safety and efficacy validation; in the clinical stage, phase I/II/III clinical validation is required. In the clinical stage, phase I/II/III clinical trials are long and costly, and need to cope with possible problems such as unsatisfactory trial data and protocol adjustments; after the market launch, it is necessary to carry out real-world studies and iterate product formulations based on clinical feedback. This "full life-cycle R&D investment" model makes enterprises face greater financial pressure in the short term, and there is uncertainty in the results of R&D. If the progress of subsequent R&D is not as expected, it may lead to difficulties in recovering the initial investment.

(2) Structural pressure on production costs

The high production cost of the product is not simply "expensive raw materials", but from the structural pressure brought by the technical characteristics -- First, the fermentation process of metabolically engineered bacteria is complex, and requires strict control of the fermentation environment (e.g., temperature, pH value, oxygen concentration) to ensure strain The fermentation process of metabolically engineered bacteria is complex, requiring strict control of the fermentation environment (e.g. temperature, pH, oxygen concentration) to ensure the stability of strain activity and gene expression, and the cost of equipment investment and energy consumption is higher than that of the standardised fermentation of traditional probiotics, R&D amortisation) are highly apportioned, further pushing up production costs. This structural cost pressure makes the product pricing higher than ordinary probiotics, which may limit the purchase of some price-sensitive consumers and affect the market penetration rate.

(ii) Consumer trust and lack of market education

(1) Trust barrier of genetic engineering technology

Consumers' knowledge of "metabolically engineered bacteria" has a natural threshold and is influenced by the one-sided perception that "genetic technology is unsafe", which makes them prone to concerns such as "whether there are potential risks in long-term consumption" and "whether genetically engineered strains will affect the stability of one's intestinal flora". "Whether genetically engineered strains will affect the stability of one's own intestinal flora" and other concerns. This barrier of trust cannot be broken simply by "promoting product safety", but requires long-term market education - both in terms of explaining the principles of the technology in layman's terms (e.g., "Genetic modification only allows strains to have a more precise ability to act) and in terms of changing its safety. action ability, will not change its safety"), but also through clinical data, authority certification (such as the State Drug Administration approval, industry associations recommended) to strengthen the trust, and this process requires a lot of time and resources invested in the short term may affect the product market acceptance.

(2) Brand awareness from zero to build

Products as innovative products, the lack of mature brand "cognitive accumulation" - compared to Kohansen, Kotobio and other brands that have been in the market for many years of ploughing, consumers have a low degree of understanding of the product, the need for "brand concept, technical advantages, product value" and other basic levels of cognitive construction. The construction of brand awareness is not simple advertising, but through "clinical cases, professional recommendations, word of mouth" and other multi-dimensional force, for example, let the patients who have used the product to share the rehabilitation experience, let the doctor in the academic conference to introduce the effect of the product's clinical application, which requires long-term accumulation, it is difficult to form a brand influence in the short term, the market competition is very low. All these require long-term accumulation, and it is difficult to form brand influence in the short term, which may put us at a disadvantage in the market competition.

(iii) Uncertainty in regulatory policy

(1) Ambiguity of regulatory classification

The domestic regulatory system for "metabolically engineered probiotics" is not yet fully mature, and the product is in the regulatory ambiguity of "medical product - food" - if it is managed as a medical product, it needs to go through a strict drug approval process (e.g. NMPA drug registration), with a long cycle and high requirements. If the product is managed as a medical product, it needs to go through a strict drug approval process (e.g., NMPA drug registration), which is long and demanding; if it is managed as a food product, although the approval process is simple, it is impossible to claim medical efficacy, which restricts the promotion of the product in medical scenarios. The ambiguity of this regulatory classification makes enterprises face uncertainty in product development, registration and promotion, for example, if the initial research and development is conducted according to food standards, and if the regulatory policy is adjusted to require the approval of drugs, it may lead to wastage of the initial investment; at the same time, there may be discrepancies in the classification of products in different regions and by different regulatory authorities, which may increase the cost of compliance and the risk of operation of the enterprises.

(2) Dynamic changes in regulatory standards

Synthetic biology, intestinal microecology is an emerging field, the regulatory policy may be adjusted with the development of technology and industry practice -- for example, in the future, more stringent safety verification standards for metabolically engineered bacteria may be introduced (e.g., increase long-term toxicity tests, environmental risk assessment), or higher requirements for clinical data on products (e.g., more centres are required.), larger sample size clinical trials). Such dynamic changes in regulatory standards may lead to the need to continuously adjust the R&D and validation programmes, prolonging the marketing cycle and increasing R&D costs; if the company fails to follow up on the policy changes in a timely manner, it may also face compliance penalties, which may affect the marketing of its products.

3.4.3 Opportunities

(I) Industry growth and market segment expansion

(1) Deep penetration of health demand upgrade

The upgrading of public awareness of intestinal health does not remain at the "conceptual level", but is gradually transformed into "scenario-based and personalised" consumer behaviour - from "general concern for intestinal health" to "targeting specific groups (including the elderly)". From "general concern for intestinal health" to "precise demand for specific groups of people (e.g. perioperative and chronic disease patients)", from "passive purchase of products" to "active search for health solutions". from "passively buying products" to "actively seeking health solutions". This demand escalation creates market segmentation opportunities for products: "high-value, high-demand" segments such as perioperative intestinal management and assisted intestinal interventions for chronic diseases currently have less competition, and products can quickly capture market share by virtue of their technological and scenario advantages; at the same time, the escalation of demand also pushes consumers to be more willing to provide products with "high value and high demand" for "At the same time, demand escalation also drives consumers to be more willing to pay a premium for products with clinical evidence and technological innovation, providing a market foundation for high pricing of products.

(2) Demonstration of demand for medical scenarios

With the popularity of the concept of "accelerated perioperative recovery (ERAS)" in domestic hospitals, perioperative bowel management has been upgraded from an "optional part" to a "necessary part". -- Physicians' demand for "reducing postoperative complications and shortening hospital stay" has become increasingly urgent, while traditional bowel management tools (e.g., common probiotics, dietary fibre supplementation) have limited effects, creating a gap in medical demand. As an innovative tool to meet this demand, the product can quickly enter the clinical pathway of hospitals by taking advantage of the promotion of the ERAS concept; at the same time, as hospitals pay more attention to "precision medicine", the product's "personalised interventions" (e.g. adjusting the regimen according to the patient's bacterial data) are also more likely to be accepted by doctors. Meanwhile, as hospitals focus on "precision medicine", the product's "personalised intervention" features (e.g. adjusting protocols according to patients' flora data) are also more likely to be recognised by doctors, further expanding the medical scenario market share.

(II) Trends in technological innovation and cross-border integration

(1) Rapid Iteration of Synthetic Biology Technologies

Technological advances in the field of synthetic biology provide new possibilities for product iteration - for example, new gene editing tools (e.g., more efficient and precise CRISPR derivatives) can improve the efficiency of strain modification and reduce the cost of research and development; in-depth research on intestinal microecology (e.g., the discovery of new bacterial metabolic pathways and key functional genes) can add new functional modules to products (e.g., for the regulation of specific chronic diseases); AI technology can be used in the development of bacterial strains, and the application scenarios of products can be expanded. Deeper research on intestinal microecology (e.g. discovery of new bacterial metabolic pathways and key functional genes) can add new functional modules to the products and expand the application scenarios (e.g. regulation of bacterial flora for specific chronic diseases); the application of AI technology in the screening of bacterial strains and optimisation of the fermentation process can shorten the research and development cycle and improve the stability of product quality. The product can rely on the existing technology foundation, rapid integration of these new technologies, continue to strengthen the technological advantage, to avoid being eliminated by the industry technology iteration.

(2) Policy dividends of the integration of Chinese medicine and modern technology

State support for the innovative development of Chinese medicine has been increasing, encouraging the integration of "Chinese medicine theory + modern technology" innovation -- the product draws on the concept of "holistic conditioning" of Chinese medicine (e.g. "Spleen is the foundation of later life" emphasises the impact of the spleen and stomach functions on the health of the whole body), and the active ingredients of TCM are integrated into the formulation of bacterial strains to optimise the product, which not only meets the policy guidance, but also creates a differentiation advantage: on the one hand, the addition of the active ingredients of TCM enhances the product's suitability for the intestinal tract of the Chinese population (e.g., adjusting the bacterial flora according to the characteristics of the dietary structure of the Chinese people); On the other hand, through modern technology to explain the mechanism of action of Chinese medicine ingredients (such as how a Chinese medicine ingredient affects the metabolism of the bacterial flora), it can promote the modernisation of the theory of traditional Chinese medicine, obtain policy support and academic recognition, and at the same time, attract the consumer groups who have a high degree of trust in traditional Chinese medicine.

(III) Synergistic Empowerment of Policies and Public Welfare

(1) Unleashing the potential of the primary care market

As the country promotes the construction of a hierarchical diagnosis and treatment system and guides medical resources to sink to the grassroots level, the volume of surgeries and the demand for chronic disease management in grassroots hospitals (community health service centres and county hospitals) are increasing - these institutions lack effective tools for perioperative intestinal management and intestinal supportive interventions for chronic diseases, and the product can fill this gap through cooperation with grassroots hospitals. Meanwhile, consumers in the primary care market have a strong demand for "cost-effective, clinically endorsed" products, so the product can launch a standardised, cost-effective version for the primary care market to quickly capture this incremental market; in addition, healthcare policy is tilted towards the grassroots level, so the product will further increase market penetration if it enters the primary care catalogue or receives reimbursement support from healthcare insurance. In addition, the health insurance policy is tilted towards the grassroots, if the product can enter the grassroots health insurance catalogue or get the support of health insurance reimbursement, it will further enhance the market penetration.

(2) Dual value of brand and data for public welfare projects

Public welfare projects such as "Beneficial Intestine Miles" are not only a manifestation of social responsibility, but also bring dual value of branding and data to the product - at the brand level, public welfare projects can enhance the social influence of the product and shape the brand image of "responsible and warm". In the brand level, the public welfare project can enhance the social influence of the product, create a brand image of "responsible and warm", differentiate it from competing products that purely pursue commercial interests, and enhance consumers' goodwill; in the data level, the public welfare project covers the remote areas of the population and special groups (such as pregnant women, pregnant women, and elderly patients with chronic illnesses), whose intestinal bacterial flora data is unique, which can be used as an important data support for the iterative development of the product (e.g., optimizing the bacterial strains and formulas according to the dietary characteristics of the people in remote areas); at the same time, the public welfare project has accumulated a lot of data, which can help to optimise the product. At the same time, the real-world data accumulated by the public welfare project can supplement the insufficiency of clinical trial data, further validate the effectiveness and safety of the product, and provide a basis for the product to enter a wider market.

3.4.4 Threats

(i) Increased competition in the industry

(1) Technology and channel suppression by international brands

International probiotic giants (e.g. Danish Cohansen, DuPont Nutrition) not only have technological advantages (e.g. richer strain resources, more mature fermentation process), but also dominate the channels and brands - these companies have established long-term cooperation with large domestic dairy companies, pharmacy chains and health management institutions, with wide channel coverage; at the same time, their brands are highly recognised in the medical sector and consumers, especially in the medical sector. These companies have established long-term relationships with large domestic dairy companies, pharmacy chains, and health management organisations, and have extensive channel coverage; at the same time, their brands are highly recognised by the medical community and consumers, especially in high-end medical scenarios (e.g., probiotics for infants and young children, and complementary interventions for chronic illnesses), where consumers are more inclined to choose international brands. When entering these markets, products face multiple challenges of "technology catch-up + channel breakthrough + brand recognition", and it is difficult to shake the market position of international brands in the short term.

(2) Rapid imitation and differentiated competition of domestic enterprises

Domestic probiotic companies (e.g. Keto Bio, JK Bio) have the characteristics of "fast response and strong localisation adaptability". If the product's market performance is good, these companies may quickly follow up by imitating the technology and launching similar products to capture the market - for example, to If the product performs well, these companies may quickly follow suit by mimicking the technology and launching similar products to capture the market - for example, launching a "general probiotic + prebiotic" combination product for perioperative scenarios to attract price-sensitive consumers at a lower price; at the same time, these companies may divert their target customers and intensify the competition in the market by differentiating their competitiveness (e.g., focusing on a particular type of surgical procedure and launching a more convenient dosage form); furthermore, the channel layouts of domestic companies in the grassroots and consumer markets In addition, domestic companies have a more mature channel layout in the grassroots and consumer markets, which may pose an obstacle to the product's market expansion.

(ii) Technology and Compliance Risks

(1) Uncertainty of technology iteration

Synthetic biology and intestinal micro-ecology fields have rapid technological updates, and if subversive technologies emerge in the industry (e.g. more efficient intestinal flora regulation technology, natural strain screening technology without genetic modification), the existing technological advantages of the product may be rapidly weakened - for example, if a company develops a natural strain with anti-bacterial and anti-inflammatory effects For example, if an enterprise develops a natural bacterial strain whose antibacterial and anti-inflammatory effects are not inferior to those of the metabolically engineered bacteria of the product, and which does not require genetic modification, it is easier to gain the trust of consumers, which will have a direct impact on the product; at the same time, technological iteration may lead to depreciation of the product's research and development investment, and if the pre-developed technological routes are eliminated, the enterprise will need to re-invest in new technological research and development, which will increase the risk of operation.

(2) Increasing compliance requirements

As the public's concern for food safety and medical product safety increases, regulators may introduce stricter compliance requirements - for example, for metabolically engineered bacteria, longer cycles of long-term toxicity tests and more comprehensive environmental risk assessment (e.g., whether or not strains of bacteria will spread in the natural environment) are required; and for medical applications, more centres and larger samples are required to be provided. For medical applications, the requirement is to provide clinical trial data from more centres and larger sample sizes, or to restrict the use of the product in specific populations (e.g., children, pregnant women). These increased compliance requirements will directly increase product development costs and launch cycles, and if companies are unable to meet the new compliance requirements, it may lead to delays in launching or withdrawing products from the market.

(iii) Fluctuations in consumer demand

(1) Changes in health consumption preferences

Consumers' preference for health products is uncertain and may change with market hotspots and information dissemination - for example, if "natural and additive-free" becomes the mainstream trend of health consumption in a certain period of time, consumers may be more inclined to choose For example, if "natural and additive-free" becomes the mainstream trend of health consumption in a certain period, consumers may prefer to choose "natural probiotics" and resist "genetically-modified" products; for example, if there is negative information about the regulation of intestinal flora (e.g., a probiotic product has been exposed as falsified in terms of its effect), it may trigger a crisis of trust in the entire probiotic category, which may affect product sales. that could affect product sales. Such changes in demand preferences are difficult to predict, and companies need to constantly adjust their marketing strategies to adapt to consumer demand, making it more difficult to operate.

(2) Diversified impact of alternative products

The number of alternative products in the field of intestinal health is not only large, but also presents the development trend of "diversification and precision" -- probiotic products play a role in regulating the proliferation of natural beneficial bacteria in the intestinal tract, avoiding the concern of "the introduction of exogenous strains of bacteria. " concerns; digestive enzyme preparations for the weak digestive function of the population, to solve the "nutrient absorption obstacles" problem; traditional Chinese medicine products rely on the theory of traditional Chinese medicine, to attract a high degree of trust in traditional Chinese medicine consumer groups; in addition, intestinal flora transplantation (FMT) and other medical technology in the field of specific diseases, also a potential competition for the products. In addition, the application of medical technologies such as intestinal flora transplantation (FMT) in the field of specific diseases also creates potential competition for products. If these alternative products gain higher recognition through technological innovation, clinical validation or market promotion, they will divert target customers from the products, especially when the products have not yet established a solid market position, the impact of alternative products may be more significant.

4 Market Analysis

4.1 Industry Status and Development Trend

4.1.1 Global and Domestic Digestive Health Industry Market Size and Growth Rate

The global probiotics market has continued to grow steadily in recent years, with the global probiotics market size expected to reach US$61.1 billion in 2021, according to Markets and Markets organisation. The global probiotics market is expected to continue to grow at a CAGR of 8.3% from 2021 to 2026, reaching $91.1 billion by 2026. Among them, North America and Europe occupy the major market share by virtue of mature consumer concepts and perfect healthcare systems, while Asia-Pacific has become the fastest-growing region in the world due to its large population base and rapid economic development. According to the data of the Probiotics Branch of the Chinese Society of Food Science and Technology, the Asia-Pacific region now has the highest consumption scale of probiotics in the world, accounting for about 44.4%, much higher than Europe (23.5%) and North America (17.8%), highlighting the momentum of the booming probiotics industry in the Asia-Pacific region. Moreover, the aging population, rising public awareness of intestinal health, and growing demand for functional foods are the core factors driving the expansion of the global market.

Although the domestic digestive health industry started late, it is growing strongly. According to statistics, the terminal market size of probiotics in China reached 134.89 billion yuan in 2024, with a CAGR of about 13% from 2018-2024, and the three major areas of end products, food and beverage, dietary supplements and animal feed accounted for 68%/19%/13%, respectively, and dairy products and dietary supplements are the main application areas of edible probiotics, and the probiotic dairy products market in China in 2024 reached 81.35 billion yuan in 2024, and the CAGR of the industry scale from 2019-2024 is about 3.59%.

With the continuous upgrading of national health consumption, the knowledge that "intestinal flora is closely related to health" has gradually become popular, and the demand for probiotic preparations and intestinal conditioning healthcare products has increased significantly. At the same time, the medical end of the perioperative intestinal management, digestive disease adjuvant therapy and other clinical needs continue to release, promoting the industry to "medical + consumption" dual-track mode of development. According to market research firms, the global output value of probiotics will exceed $88 billion in 2025, and China will account for at least 25% of the global share. Moreover, according to the data of the Probiotics Branch of the Chinese Society for Food Science and Technology, it is expected that the domestic probiotic market size (calculated in the same calibre as the company's sales products) will reach 14.96 billion yuan by 2027, of which the market size of domestic manufacturers will reach 7.48 billion yuan.

4.1.2 Domestic environment

Since 2015, China's pharmaceutical innovation has ushered in a golden era, with the successive catalysing of a series of policies such as the creation of major new drugs by the state, the reform of drug supervision, the 18A of the Hong Kong Stock Exchange and the Science and Technology Innovation Board, and the rapid growth of the innovation capacity of domestic pharmaceutical enterprises. The Administrative Measures for Mutual Recognition of Inspection and Test Results of Medical Institutions clearly puts forward that medical institutions should follow the principle of "guaranteeing quality and safety as the bottom line, qualified quality control as the prerequisite, lowering the burden on patients as the guide, meeting the demand for diagnosis and treatment as the root, and the judgement of the receiving physician as the standard"; in 2015, the General Office of the State Council issued the Guiding Opinions on Promoting the Construction of a Graded Diagnosis and Treatment System", and since then, corresponding systems and measures for graded diagnosis and treatment have been introduced across the country, promoting structural changes in the diversion of outpatient traffic from tertiary hospitals to hospitals below the second level, enabling primary care to play a role in making the best use of social resources; at the same time, policies such as the medical insurance fee-control policy have reduced unnecessary expenditures in the medical fees, efficiently met the demand for medical treatment, reduced unreasonable waste of resources and promote the development of domestic enterprises. National policies continue to guide the sinking of medical resources to the grassroots level and increase the investment of resources in the grassroots level.

Policies related to the probiotic industry
Time	Policy	Main Content
2020/7	National Rural Industry Development Plan (2020-2025)	Develop functional foods suitable for special populations.
2021/3	Outline of the 14th Five-Year Plan for National Economic and Social Development and the Long-Range Objectives Through 2035	Propose strict food and drug safety supervision, strengthen and improve food and drug safety supervision systems, improve food and drug safety laws, regulations and standards systems, explore the establishment of a national food safety preventive mechanism, deeply implement the food safety strategy, promote the construction of a food safety, increase the joint rectification efforts on food safety issues in key areas, and strengthen food and drug safety risk monitoring, sampling inspection and supervision law enforcement.
2022/6	Guiding Opinions on Promoting the High-Quality Development of Light Industry	Vigorously develop new products. Focus on the urgent needs of health, infant and child care, aging and other aspects, and increase the research and development of functional foods, cosmetics, leisure fitness products, important supplies, and aging-friendly light industry products.
2022/8	14th Five-Year Plan for Food Safety Standard and Monitoring and Evaluation	Clarify the "four strictest" measures: first, implement the "four strictest" and the most rigorous risk identification and assessment work system; second, improve food safety supervision and management standards; third, implement the national nutrition plan and the reasonable diet action; fourth, strengthen support and guarantee, and lay a solid foundation for development.
2022/12	National Standard for Beverages (GB19101-2022)	Clarify that products with added live bacteria required by the new national standard should indicate the number of live bacteria on the label, and also require warning labels.

4.1.3 Analysis of industry driving factors and constraints

In terms of industry driving factors, the first is the promotion of health awareness, the current national awareness of "intestines are the second brain" and "flora imbalance is associated with chronic diseases" is deepening, and there is a growing demand for active prevention of intestinal problems, which has given rise to the consumption of daily digestive health management, such as perioperative patients and their families to reduce the risk of postoperative infection and intestinal paralysis. Health management consumption, such as perioperative patients and their families in order to reduce the risk of postoperative infections, intestinal paralysis and other risks, the acceptance of products to accurately regulate intestinal flora has increased significantly. Secondly, it is fuelled by technological innovation. In synthetic biology, in May 2024, the Tianjin Institute of Industrial Biotechnology of the Chinese Academy of Sciences developed CRISPR-edited probiotic strains for the degradation of uric acid, which promotes the differentiation of products and allows the research and development of engineered bacteria to move from theory to practical application, such as the metabolism of the project's engineered bacteria to achieve targeted repair of intestinal micro-ecology through the precise control of genetic elements, which provides differentiated solutions for the field of digestive health. This provides differentiated solutions for digestive health and promotes the industry to upgrade from "broad-spectrum conditioning" to "precise intervention". In addition, the pull of medical demand can not be ignored, with the number of surgeries increasing year by year, such as gastrointestinal surgery, orthopaedic surgery, etc., perioperative intestinal flora disorders caused by infections, malnutrition and other complications, not only to increase the pain of the patient, but also improve the cost of medical care, the urgent need for efficient intestinal regulation means that the clinical level of the digestive health of the products to open up the market for the immediate needs of the medical level. Moreover, with the continuous development of the network, the gradual penetration of e-commerce has further boosted consumer spending momentum in this area. China's online sales of digestive health products will increase from 32% in 2020 to 48% in 2023, with live e-commerce and cross-border platforms driving a 56% increase in consumption in the sinking market

However, the development of the industry is also facing some constraints. First, the regulatory policy lag, engineering bacteria products in the "medical - food" regulatory ambiguity, the country has not yet issued a clear approval standards for metabolic engineering bacteria and classification and management specifications, resulting in the transformation of the product from the laboratory research and development to clinical application of the process is complex, the cycle is longer, increasing the cost of compliance and the risk of enterprises listed on the market. Second, consumer trust barriers, some consumers have safety concerns about "genetically engineered bacteria", worried about the potential risks of long-term consumption or use, coupled with the market has appeared in the probiotic products, "efficacy of false labeling" of the chaotic phenomenon, all of these emerging technology products market education and promotion adversely affected. All these adversely affect the market education and promotion of new technology products. Thirdly, the high cost of technology, metabolic engineering bacteria research and development involves gene editing, strain screening, clinical verification and other aspects, the initial R & D investment is large, and in the small-scale production stage, fermentation, purification process is complex, the unit cost of the product remains high, which, to a certain extent, limits the purchase of price-sensitive consumer groups.

4.2 Target market segmentation and positioning

4.2.1 Market segmentation dimensions: age, gender, consumption ability, etc.

Segmentation from the age dimension, the middle-aged and elderly group (50 years old and above) is the high incidence of digestive diseases, and at the same time, they have a relatively high probability of surgery due to changes in body functions, such as oncology surgery, joint replacement, etc., so the demand for perioperative intestinal management is very urgent, and they are more inclined to choose the medical-grade digestive health products with clear efficacy, and are more concerned about the product's safety and clinically validated data. They are more inclined to choose medical-grade digestive health products with clear efficacy, and are more concerned about product safety and clinical validation data, and have stronger willingness to pay. Young and middle-aged people (25-49 years old) have a common state of intestinal sub-health due to work pressure and irregular diets. They pay attention to the maintenance of digestive health in their daily life, and there is a strong demand for convenient and efficient consumer-grade intestinal health products, as well as a greater willingness to accept innovative technological products, such as preventive engineered bacterial preparations, which can be used to reduce the risk of future surgeries or alleviate chronic intestinal discomfort. "Preventive" engineered bacterial formulations.

In terms of gender, women have a deeper understanding of the link between intestinal health and skin condition and endocrine regulation, and a more precise need for intestinal flora regulation during perioperative periods, such as gynaecological surgery. Moreover, women usually take a leading role in family health consumption decisions, and are a key demographic for product promotion, and are interested in the dosage form of the product, such as taste, portability, and the brand's added value, such as health popularisation and community services. At the same time, they have higher requirements for product dosage forms, such as taste and portability, as well as brand added value, such as health popularisation and community services. Men's intestinal problems are mostly related to alcohol and tobacco intake, socialising and eating, and they are more prone to serious bacterial imbalance during perioperative periods, such as liver and gallbladder surgery, gastrointestinal surgery, etc. Their demand for products is more focused on "quick results" and "solving practical problems" than details such as product dosage form. They are more concerned about the product efficacy description and clinical data than the details of the product dosage form.

From the dimension of consumption ability, high consumption ability groups can afford the price of high-end medical grade products, such as customised metabolically engineered bacteria preparations for perioperative accurate intestinal management, and they are willing to pay a premium for "personalised solutions + exclusive medical services", and they will pay attention to the background of the product research and development team, technical patents, and other endorsements. They are willing to pay a premium for "personalised solutions + exclusive medical services". The medium consumption ability group pursues "cost-effectiveness + clear efficacy", and is more inclined to choose standardised and mass-produced digestive health products, such as general engineering bacterial preparations that can be used for daily intestinal conditioning or perioperative interventions. Although they are more price-sensitive, they recognise the value of the innovative technology, and they are the core group that drives the volume of the market. They are more price sensitive but recognise the value of innovative technology, which is the core group driving the market volume.

4.2.2 Target Market Selection Basis

Based on the rigid medical needs arising from perioperative intestinal dysbiosis, the project focuses on the "medical-grade perioperative intestinal management market", which mainly covers two groups. One is surgical patients, especially those undergoing major surgeries such as gastrointestinal, orthopaedic and oncology operations. These patients have a high incidence of perioperative intestinal dysbiosis and face a high risk of postoperative infections, intestinal dysfunction and other complications, and clinically there is an urgent need for effective intestinal regulation, and the project's metabolically engineered bacterium is able to precisely regulate intestinal flora and inhibit inflammation, which can be very well suited to the rigid needs of this medical scenario. The other category is the middle-aged and elderly families of surgical patients, who, as the main body of decision-making and payment of medical consumption, are very concerned about the quality of post-operative rehabilitation and prevention of complications, and have a strong demand for products that "reduce medical risks and subsequent expenditures", and are willing to pay for professional medical-grade products, and at the same time are more likely to come into contact with the relevant products through the hospital channel. The company is willing to pay for professional medical-grade products, and it is also easier to access related products through hospital channels.

While focusing on the medical-grade market, the project has also simultaneously laid out the "consumer-grade daily intestinal care market", which mainly covers the young and middle-aged intestinal sub-healthy people. With the efficacy of the product "precisely regulating the bacterial flora and relieving chronic intestinal discomfort", the project meets the daily health maintenance needs of this group, and helps them cultivate long-term consumption habits through online consumption channels and health popularisation, so as to build up a user base for the medical-grade market and enhance brand awareness.

4.2.3 Product Market Positioning: Differentiated Competitive Advantages

Firstly, in terms of technological differentiation, unlike the traditional probiotics which are characterised by "broad-spectrum regulation and vague efficacy", the metabolically engineered bacteria of this project are precisely designed based on synthetic biology. On the one hand, it achieves precise targeting, responding to intestinal bile salt signals through the p16090 promoter, so that the engineered bacteria can be specifically activated in the intestinal tract, avoiding systemic side effects, and effectively solving the pain point of traditional probiotics, which is "fuzzy action scenes and unstable effects"; on the other hand, it achieves clear efficacy, integrating OLE1, On the other hand, the efficacy is clear, the integration of OLE1 and accA genes enhances the expression of oleic acid (OA), and at the same time synergises with DEFB4A gene to regulate the immune system, which can inhibit the harmful bacteria that are prone to infections in the perioperative period, such as Escherichia coli and enterococci, etc, and also alleviate the intestinal inflammation, so that it can intervene in the dual dimensions of "bacterial regulation and immune restoration". Compared with single probiotics or prebiotics, it is more targeted to the complex intestinal problems during surgery.

In terms of scenario differentiation, the project focuses on "perioperative medical scenarios", filling a gap in the clinical field. Traditional digestive health products are mostly oriented to daily care, but lack precise solutions for special physiological conditions before and after surgery, such as fasting, traumatic stress, antibiotic use, etc. The project's engineered bacteria can be suitable for perioperative medical conditions. The engineered bacteria of this project can adapt to the microecological characteristics of the intestinal tract during the perioperative period, optimise the intestinal flora structure of patients and reduce the risk of infection before surgery, and help the recovery of intestinal function after surgery, thus becoming an innovative supplement to the "accelerated recovery in perioperative period (ERAS)" system, and through the in-depth combination of the clinical pathway in hospitals, it will build up an exclusive competitive barrier in the medical field. It also builds up a competitive barrier exclusive to the medical scene by deeply integrating with the clinical pathway of hospitals.

Focusing on value differentiation, the medical and consumer values of the products are outstanding. In terms of medical value, after the product has passed clinical validation, it can be used as an auxiliary medical tool for perioperative intestinal management, and be incorporated into hospital prescriptions or clinical pathways, providing doctors with new treatment tools and helping to reduce the incidence of postoperative complications, such as the infection rate is expected to be reduced by 30%, and the length of intestinal paralysis will be shortened by 12 hours, creating more value for the medical side. In terms of consumer value, for daily intestinal care users, the product can provide long-term health benefits of "precise prevention of surgical risks" and "repair of chronic intestinal damage", which is different from the limitations of ordinary probiotics of "short-term relief". Unlike ordinary probiotics that provide "short-term relief", the product builds up the value of "prevention-intervention-recovery" in the whole cycle of intestinal health management, which helps to increase the long-term repurchase rate and brand loyalty.

4.3 Analysis of Consumer Needs and Buying Behaviour

4.3.1 Consumer demand pain points for digestive health products

In some medical scenarios, perioperative patients and their families face many demand pain points. The first is the problem of unclear effect. Traditional intestinal conditioning products, such as ordinary probiotics, will have a significantly attenuated effect under the complex environment of perioperative fasting and antibiotic interference, and are unable to effectively prevent infections, intestinal paralysis, and other complications, which still puts the patients at a higher risk after surgery and makes their families worried about the quality of their recovery. Secondly, safety concerns, perioperative patients with low immunity, the "foreign bacterial agent" safety requirements are extremely high, they are worried that ordinary probiotics may carry drug-resistant genes, triggering infections, or due to the instability of bacterial strains affecting the efficacy of the treatment, so they do not dare to try easily. In addition, the poor convenience of use is also a major pain point, most of the existing products are oral capsules or powders, perioperative patients may have difficulty swallowing, intestinal absorption obstacles and other problems, and the lack of "preoperative - intraoperative - postoperative" whole cycle of the use of the programme guidance, which undoubtedly increases the operating costs of healthcare personnel and patients.

In daily consumption, there are also many pain points in the demand for daily intestinal care. First, the lack of precision, ordinary probiotics using the "thousands of people a party" mode, can not be for individual intestinal flora imbalance type of precise adjustment, such as harmful bacteria advantage, inflammation level differences, resulting in long-term effect varies from person to person, many users will be "ineffective! "Many users will give up using it because it is ineffective. Secondly, long-term dependence on hidden dangers, some products contain additives, and rely on exogenous strains of bacteria colonisation, long-term use may damage the balance of the intestinal flora, users are concerned about the situation of "the more you adjust, the more weak", so there is a strong demand for safe, sustainable conditioning solutions. Thirdly, the weak scene adaptation, daily consumer products do not distinguish between "general conditioning" and "surgical prevention" scenarios, for potential surgical needs of the population, such as physical examination found that polyps need to be resected, the lack of targeted products that can intervene in advance to reduce the risk of surgery, can not meet their "prevention - prevention" and "prevention". For people with potential surgical needs, such as those who need to have polyps removed after medical checkups, there is a lack of targeted products that can intervene in advance and reduce the risk of surgery, thus failing to satisfy their coherent "prevention-treatment" health needs.

4.3.2 Decision Logic for Purchasing Behaviour

When we are in a healthcare scenario, information reliance and payment priority are the key influencing factors in the purchasing decision. Perioperative patients and their families mainly rely on "doctor's recommendation + clinical data" as the core decision-making basis, and they will give priority to trusting hospital channels, professional medical journal papers (e.g., JCR Q1-Q2 papers published by the target of this project), and clinical trial data, and are highly sensitive to information such as "medical grade certification", "hospital cooperation cases", and so on. They are highly sensitive to information such as "medical grade certification" and "hospital co-operation cases" of the product. In terms of payment, they prioritise "reducing post-operative risk and healthcare expenditure", and are willing to pay more for clinically validated and effective products.

In the consumption scenario, experience-driven and long-term value concerns play an important role. Young and middle-aged users pay more attention to "trial experience + community word-of-mouth", they will build trust in the product through small-size trial packs, sharing by health bloggers or patient communities, and they are more sensitive to the immediate feedback of "relief of intestinal discomfort after taking the product", such as reduction of bloating, regularity of bowel movement, and so on. They are more sensitive to the immediate feedback of "relief of intestinal discomfort after taking the product", such as abdominal distension, regular bowel movements, etc. Short-term effects have a greater impact on their repurchase behaviour. Highly educated, high-consumption groups are more concerned about the technical logic of the product, such as synthetic biology design, gene component function, etc. They recognise the long-term health value of "precise regulation, without destroying their own flora", and are willing to pay a premium for the innovative technology, and will also compare the product's academic endorsement, such as results of the iDEC Competition, Medical Innovation Competition, and the qualifications of the R&D team when making decisions. When making decisions, they will also compare the product's academic endorsement, such as the results of iDEC competition and medical innovation competition, and the qualification of the R&D team, such as the background of Lanzhou University School of Stomatology.

When it comes to channel preference, there is a clear difference between consumers in medical and consumer scenarios. Consumers in the medical scenario mainly rely on the "hospital pharmacy + doctor's prescription" channel, and they are willing to purchase the product through the hospital payment system, believing that "hospital access" is an important endorsement of the safety and effectiveness of the product, and at the same time, they also pay attention to the "post-operative follow-up service". At the same time, they are also concerned about "post-surgery follow-up services", such as whether they can access the doctor's intestinal flora monitoring after purchasing the product, and obtain personalised adjustment plans, etc. These services can further enhance their willingness to purchase. Consumers in the consumption scenario prefer "online health platforms (e.g. Clove Doctor, Jingdong Health) + community e-commerce" channels, they understand and recognise the products through health science articles and user cases, and pursue "convenient purchasing + privacy", and are interested in "subscription-based (e.g. monthly subscription)" products. "They also have a high acceptance of subscription-based products (e.g. monthly intestinal care packages) and additional health management services (e.g. bacterial flora testing, dietary advice), and their repurchase behaviour is mostly triggered by online automatic renewal or community recommendations.

4.4 Competitive Landscape and Competitive Products Analysis

4.4.1 Analysis of domestic enterprises

Cowei Bio: as a leading probiotic company in China, Cowei Bio has constructed a whole chain development mode of "strain screening-functional validation-industrialisation", and independently researched and developed more than 20 patented strains of Bifidobacterium animalis Lactis subspecies V9, Lactobacillus casei Zhang, etc. Among them, the KEX02 live bacteria drug pipeline developed based on V9 has obtained clinical approval from the US FDA. Among them, the KEX02 drug pipeline developed based on V9 has obtained the clinical approval from the US FDA. The survival rate of the strains in the artificial digestive environment is over 90%, and the scale production has been realised through the intelligent factory in the new district of Helinger, Inner Mongolia. In terms of industrial chain, the company owns Asia's largest lactobacillus resource bank in the upstream (36,174 strains of lactobacilli will be isolated, identified and preserved by 2024), and provides raw material bacterial powder for Mengniu and Bright Dairy in the downstream, as well as launches its own brand of probiotic end-products, "Yisiyu".The total revenue will be RMB 299 million in 2023, of which 64% will be from the edible probiotic business. Probiotics business accounted for 64%, gross profit margin of 65.63%. On the marketing side, the concept of "Chinese Mushroom" strengthens the local advantage, and the online and offline channels are covered. In terms of business model, Keto Bio takes B2B business as the core (compounding and probiotic raw materials will account for more than 80% in 2024), while expanding B2C terminal products (own brand "Yishiyou"). 2024 total revenue of 303 million yuan, gross margin of 58.25%, the edible probiotic business accounted for 85.57% of the total revenue of 303 million yuan, and gross margin of 85.57%. Absolute core. The marketing side of the "Chinese bacteria" academic endorsement to strengthen the local advantage, online layout of e-commerce platform, offline coverage of drugstores, maternal and child channels. Domestic probiotic raw materials market is still dominated by foreign companies, Keto Bio is in the accelerated stage of domestic substitution. On the marketing side, the company adopts academic endorsement and omni-channel penetration strategy, promoting the concept of "local strains adapted to the intestinal tract of Chinese people" through Jitterbug KOL online, and relying on pharmacies and maternal and child shops to provide free intestinal testing to attract traffic offline.

GenMont: With ODM service and functional strain R&D as the core, its core technology of room temperature live bacteria embedding technology, cooperated with Yili and National Dairy Technology Innovation Centre to solve the problem of probiotics survival in room temperature dairy products. It has independently researched and developed China's first strain of edible bacteria for infants and young children, MP108, which broke the monopoly of Europe and the United States on China's probiotic market for infants and young children. It has set up innovative R&D centres at home, in Europe, Australia and other places, and constructed Ausnutria's global R&D system of "1+6+N", as well as long-term and in-depth industry-academia-research cooperation with renowned colleges and scientific research institutes at home and abroad. It also carries out long-term and in-depth cooperation with renowned universities and research institutes at home and abroad, and is committed to solving key technical problems in the field of nutritional and health food. With 30+ functional strains screening platforms and more than 1,000 strains in stock, JCB has obtained 106 probiotic patents and published more than 100 articles in domestic and international literature, and is in the leading position of scientific and technological innovation in probiotic segment. In terms of profitability, JQB will have total assets of RMB292 million in 2023, which will be mainly derived from the sales of B2B raw material bacterial powder (e.g. supplying to Yili and Mengniu) and its own branded end products such as "Yishiyou" and "Aiyisen". JQB can also provide ODM and OEM one-stop multifunctional OEM services, including ready-to-eat lactobacilli powder, whey fermentation liquid, customised functional bacterial powder, oral tablets, functional drinks, throat lozenges, lactobacilli fermentation concentrates, and health food products, etc. JQB has strengthened its scientific image through joint clinical trials with tertiary hospitals, publication of the "China Infant and Young Children's Probiotic White Paper", and promotion through all channels such as drugstores, maternal and child shops, e-commerce, etc. (e.g. JQB's own brand "Yishiyou", "Aiyisen", etc.). JCB has strengthened its scientific image through clinical trials with top tier hospitals, publication of China's white paper on probiotics for infants and young children, and promotion through pharmacies, maternal and child stores, e-commerce and other channels (JCB cooperated with KAIRI to use BC30 strain - applied to "Super Lemon Tea" by Xi Cha)

4.1.2 Analysis of International Enterprises

Chr. Hansen (Denmark): providing comprehensive services of "strain+process+equipment", Chr. Hansen is the world's leading probiotic supplier, with a global market share of about 12% in 2024, its core competitiveness stems from the world's largest strain resource base, patented microencapsulation technology and large-scale production capacity. In the Chinese market, Cohanessen has technical cooperation with Danone and other companies to provide strain customisation and process support. Its Danish plant "Air 7" is the world's largest probiotic monomer fermentation base, which supports the supply of raw materials for dairy products and healthcare products. Its core profit model is B2B supply of raw materials (dairy products, healthcare products, etc.) and private label end products (e.g. BBG Probiotics). Probiotic raw materials (e.g. BB-12, LGG strains) are expensive (more than 10,000 RMB/kg) and enjoy high premiums due to the strains' clinical validation and brand advantages. Its market position is due to strain safety certification, BB-12 and LGG have been certified by EU QPS and US GRAS, which have become the industry safety benchmarks, while the joint release of China's Probiotics for Infants and Young Children White Paper strengthens the scientific credibility.

DuPont Nutrition & Biosciences: Its Nutrition & Biosciences division focuses on the research, development and production of probiotics, and owns the HOWARU® series of probiotic brands, covering adult, children, women and other market segments. The core strains include Lactobacillus acidophilus NCFM®, Bifidobacterium bifidum HN019®, etc., which are clinically proven to improve intestinal motility and enhance immune cell activity. With production bases all over the world, the company adopts advanced fermentation process and freeze-drying technology to ensure stable activity of the strains during processing and storage. The company will have a probiotic market share of about 8% in China in 2024, and has established long-term partnerships with Mengniu, Yili, and other dairy companies, and its compound probiotic formulas have been widely used in yoghurts, probiotic beverages, and other products.

Bayer: As an internationally renowned pharmaceutical company, Bayer's probiotic products rely on its pharmaceutical R&D background and focus on the efficacy and safety of strains. Its core products include Da Yi Xi probiotics (containing Bacillus subtilis R-179 and Enterococcus faecalis R-026, which regulate the balance of intestinal flora) and children's chewable probiotics (containing Bifidobacterium lactis Bi-07®, with 5 billion CFUs of viable bacteria per tablet), which are manufactured using imported production equipment from Germany, with strict control over the cleanliness of the production environment. 2024, Bayer will be selling its products as "pharmaceutical-grade quality" in the Chinese probiotic market. Pharmaceutical-grade quality" as a selling point in the Chinese probiotic market, through drugstores, online platforms and other multi-channel sales, market coverage of more than 60%, user satisfaction surveys show that 85% of consumers believe that it is effective in relieving diarrhoea.

5 Marketing Strategy

5.1 Brand Building and Promotion

5.1.1 Brand positioning and core value proposition

Against the background of increasingly fierce competition and serious product homogenisation in the current probiotic market, the digestive tract probiotic capsule launched by our project, relying on the scientific research strength of the Medical College of Lanzhou University, establishes a differentiated brand positioning from the source. Unlike many probiotic products on the market that only emphasise general intestinal health functions, this product focuses precisely on the specific market segment of perioperative people, positioning the brand as "perioperative digestive microecological balance expert". Perioperative people are susceptible to imbalance of intestinal microbiota due to various factors such as surgical trauma, use of antibiotics, change of dietary structure, psychological pressure, etc., which may lead to a series of complications, such as postoperative infections, intestinal dysfunction, etc., and seriously affect the recovery process and the quality of life of the patients after the operation. At present, there is a relative lack of professional probiotic products in the market for the intestinal health needs of this special group of people. Either the general-purpose products are unable to meet the special physiological needs of the perioperative period, or there is a lack of adequate scientific research support and clinical validation. This product is to seize this market gap, with the unique metabolic engineering bacteria technology, can accurately respond to the bile salt signal in the intestinal tract, regulate the balance of intestinal flora, inhibit the growth of harmful bacteria, and at the same time inhibit the inflammatory response, for the perioperative period of the people's intestinal health escort.

The core value proposition of the brand is centred on the three dimensions of "scientific research empowerment, precise protection, safety and effectiveness". The "scientific research empowerment" is reflected in the whole process of product research and development, from the screening of bacterial strains, genetic engineering modification, to the optimisation of the fermentation process, the determination of dosage forms, every link has the participation of Lanzhou University's professional scientific research team and strict control, relying on the advanced molecular biology technology and a wealth of clinical research data, to ensure that the product's scientific and innovative nature. Innovation. "Based on the in-depth research on the characteristics of intestinal physiological changes of perioperative people, the metabolic engineering bacteria in the product can precisely act on the key links of intestinal flora imbalance during the critical period of perioperative period, and solve the problem of disorders of intestinal flora in the perioperative period by generating specific metabolites (e.g., oleic acid) and regulating the activity of immune cells. By producing specific metabolites (e.g. oleic acid) and regulating immune cell activity, it can target the perioperative period to solve the problem of intestinal flora disorders and provide strong support for patients' postoperative recovery. "Safety and efficacy" is the bottom line and commitment of our brand. The strains used in the product have undergone strict safety assessment and are in compliance with relevant national regulations and standards, and the production process follows GMP norms to ensure stable and reliable product quality; at the same time, through a large number of in vitro experiments and animal experiments, as well as subsequent clinical studies, the product has fully demonstrated its ability to improve perioperative intestinal bacterial flora. At the same time, through a large number of in vitro and animal experiments, as well as the subsequent clinical research, the product has fully proved its remarkable effect in improving the balance of perioperative intestinal flora and reducing the incidence of postoperative complications.

5.1.2 Brand Identity Design 5.1.3 Promotion Channels and Strategies

The promotion strategy focuses on the hierarchical goal of "building trust in the professional crowd and expanding awareness in the general public", and achieves precise communication through a combination of multiple channels. At the level of advertising, professional medical media is the core position for establishing the authority of the product - targeting surgeons, anaesthesiologists and other medical personnel, delivering the R&D background and clinical data through medical journals and medical platforms, and opening up the entrance of clinical application through the recommendation of professionals; at the same time, the mass health media and outdoor advertisements form a scenario-based coverage, with the former providing popular and popular advertisements. At the same time, mass health media and outdoor advertisements form a scenario-based coverage, with the former using popular science to bring patients' families closer, and the latter reinforcing the recognition of the product as a "perioperative speciality" in core scenarios, such as hospitals and residential areas, to achieve the dual effect of "professional endorsement + mass penetration". Social media marketing focuses on "content seeding + interactive conversion", shaping the brand's professional image through popular science content (such as knowledge of intestinal flora care), enhancing user participation with interactive activities such as knowledge quizzes and topic challenges, and then combining with KOLs in the medical field to output professional reviews, breaking down the barriers of consumer trust through their word-of-mouth. The overall promotion logic has upgraded from "information transmission" to "user resonance", which not only ensures the rigour of medical attributes, but also takes into account the fun of mass communication.

Type of promotion	Concrete way	Target audience	Core content/strategy	Dominance
Advertising placement	Specialised medical media advertising	Perioperative patients and families, medical professionals (surgeons, anaesthetists, etc.)	1. Medical journals: academic advertisements/product introductions focusing on R&D background, mechanism of action, and preclinical data. 2. Medical websites/APP: Advertisements combined with online seminars and expert lectures.	Communicate professional information, enhance recognition in the medical community and promote clinical application through professional recommendations
Mass health media advertising	average consumer	1. Health TV programme: introduce the importance of perioperative intestinal health and the advantages of the product. 2. Health newspapers/magazines: publish popular science articles (implant product information) 3. Social media health accounts: collaborating on popular science content	Increase public awareness and leverage account fan base to expand reach
outdoor advertising	Hospital patients and their families, families with post-surgical rehabilitation needs in residential areas, and health and wellness groups	1. Hospital neighbourhood: highlight perioperative-specific attributes and core strengths 2. Residential areas (bulletin boards, lift intervals): delivering information on bowel care needs 3. Commercial centres: attract potential consumers and enhance brand awareness	Accurate coverage of the scenario-based crowd to increase product exposure
Social Media Marketing	content marketing	Perioperative patients and their families, people concerned about intestinal health	1. Platform: WeChat, Weibo, Shake, Xiaohongshu 2. Content: popular science (intestinal flora imbalance, nursing knowledge), product information (ingredients, usage), scientific research progress, user cases 3. Format: graphic, video, animation	Create a professional and authoritative brand image, and improve the fun and readability of the content
interactive marketing	Social media users, potential consumers	1.Knowledge Quiz (WeChat public number, with product trial packs and health gift rewards) 2. Topic challenges (Shake voice / Xiaohongshu "post-surgery rehabilitation diary", quality content likes and retweets) 3. Online live broadcast: invite research team and clinicians to explain and answer questions.	Enhance brand-consumer adhesion, inspire participation and answer user questions
KOL Co-operative Marketing	KOL fans (perioperative care, gut health followers)	1.Select KOL: medical experts, senior nurses, health science bloggers 2. Form of co-operation: product reviews, usage videos, online live broadcasting 3. Content: Introduce the advantages from a professional point of view, share clinical observation/use experience	Leveraging KOL word-of-mouth to enhance product credibility and influence, and accurately reach target fans.

5.1.4 Sales channel layout

Sales channels are designed based on the principle of "covering different consumption habits and matching the purchasing scenarios of the target group", building a three-dimensional network with online and offline linkage to ensure that consumers can find the product when they need it and have access to it when they want to experience it.

Online channels Undertake the function of "traffic undertaking and convenient purchase": comprehensive e-commerce platforms (Tmall, Jingdong, etc.) rely on a large user base to expand exposure, vertical health e-commerce (Jianke.com, etc.) to accurately reach the health needs of the population, and its own official website, as the core of the brand's independent operation, integrates the product display, health popularisation and member services, forming a "platform to attract traffic - to match the target group's purchase scenarios". The official website serves as the core position for the brand to operate independently, integrating product display, health science and member services to form a closed loop of "platform diversion - official website precipitation"; live broadcasting as an emerging complement to the professional anchor to explain and limited-time offers, to achieve "instant interaction - rapid transformation", especially for families of post-surgery patients who have urgent needs.

Channel Type	Co-operation Platforms / Building Priorities	operating strategy	dominance
E-commerce platform	Comprehensive e-commerce: Tmall, Jingdong, Pinduoduo (open official flagship shop) Vertical health e-commerce: Jianke.com, 1Pharmacy.com, Kang Aiduo	1. Optimise product detail pages (features, user reviews) 2. Participate in platform promotions (618, Double 11), use discounts/full reductions/giveaways to attract purchases 3. Vertical platforms: co-operate with health consultants to provide advice and participate in health thematic activities	Comprehensive platform: large traffic, broad user base, covering multiple consumption levels Vertical platform: precise target audience, strict auditing to enhance the degree of trust
Own official website	Functional design, website optimisation, official website promotion	1. Functions: product display, online purchase, order enquiry, health science, member management 2. Optimisation: SEO (keywords such as "perioperative probiotics"), loading speed, security protection 3. Promotion: labelling URL (social media/packaging), friendly links, email marketing	Autonomous control of brand display, sales and service to enhance professionalism and user stickiness
live streaming with goods	Taobao Live, Jingdong Live, Jitterbug Live, Shutterbug Live	1. Anchor selection: medical professional anchors (medical experts), general anchor with goods 2. Content design: product selling points, use scenarios, user cases, interspersed with interaction (Q&A/lucky draw) and limited-time offers 3. Promotion: Send advance notice (social media/e-commerce shops), use platform tools (DOU+) to expand exposure.	Highly interactive, high conversion rate, rapid increase in sales and brand awareness

Offline channel：Focuses on "value-added experience and scenario penetration": pharmacies (especially pharmacies around hospitals) directly reach the core target group, and strengthen the product positioning of "special for perioperative period" through sales staff training and terminal display; superstores cover the mass consumption Supermarkets cover mass consumption scenarios, lowering the threshold of purchase through bundled sales and tasting trials; health experience shops, as a high-end service carrier, meet the dual needs of middle- and high-end people for "professional services + product experience" through value-added services such as health testing and personalised consulting, and have become an important window for upgrading the brand's image.

Channel Type	Cooperation Objects / Construction Priorities	operating strategy	dominance
Pharmacy	Large chain pharmacies (People's Pharmacy, Yifeng Pharmacy), pharmacies around hospitals, community pharmacies	1. Terminal construction: set up exclusive display area (entrance, cashier), with promotional materials; training of sales staff (product knowledge + sales skills) 2. Promotional activities: free gifts (health gifts), full reduction, exclusive member discounts; hold health seminars	Highly specialised, high consumer trust, direct access to core target group (perioperative patients)
Retail outlets	Large supermarkets (Wal-Mart, RT-Mart), high-end boutique supermarkets (Ole', BLT), medium-sized supermarkets in residential areas	1. Display: Selected food area / health care products area, high-end supermarkets set up independent display cabinets 2. Promotion: special price, bundled sales (with probiotic milk powder / dietary fibre food), tasting trials 3. Promotion: Use supermarket radio and electronic screen to release information.	High traffic volume, wide coverage; high-end supermarkets to match the middle and high-end consumer groups, to enhance the brand image
Health Experience Store	Around hospitals, high-end residential areas, commercial centres (key cities)	1.Selection of site decoration 2. Services: product trial, health counselling, basic testing (blood pressure / blood sugar), post-operative rehabilitation guidance 3. Customer maintenance: build customer files, regular visits, organise members-only activities (health lectures, tastings)	Provide professional and personalised services to enhance brand trust and stickiness and customer loyalty

In terms of channel cooperation and benefit distribution, we design differentiated models for different channels (e.g., joint marketing for e-commerce, strategic distribution for drugstores, and self-operated joining for experience shops), and protect the enthusiasm of channel partners through fair profit distribution mechanisms (e.g., ladder rebates, cost-sharing) to achieve a "brand-channel-consumer" win-win situation for all three parties. Win-win situation.

Channel	Mode of cooperation	Benefit-sharing mechanisms
E-commerce platform	Shop stationing (brands operate on their own, platform provides technical/traffic support); joint marketing (co-organised promotional activities)	Brands: sales revenue - costs (product/promotion/logistics) = profit Platforms: receive technical service fees, transaction commissions, advertising costs; joint activities share revenue according to inputs
Pharmacy	Distribution co-operation (brand supply, pharmacy sales); strategic partners (large chains, in-depth co-operation in R&D/research)	Pharmacy: sales price - supply price - operating costs = profit brand: supply price - product costs - promotion costs = profit; strategic cooperation to set up sales rebate or share of investment ratio
Retail outlets	Inbound sales (brand sends product, superstore provides space); joint promotions	Proportionate share according to the agreement (brands get most of the revenue, supermarkets get the revenue from venue services); joint activities share the cost and revenue according to inputs
Health Experience店	Self-operated (brand side investment and operation); Franchise (authorised franchisee with brand/product/operation support)	Self-employment: the brand gets all the profits, bear all the cost risks Franchise: the franchisee gets the profit - cost - franchise fee / management fee; the brand collects the franchise fee / management fee / product profits, set up a ladder of rebates

5.2 Pricing Strategy

5.2.1 Pricing logic

In terms of pricing logic, we have to take into account the cost and market competition, so we intend to choose the cost-plus method, based on the whole chain of costs (production, R & D, marketing), superimposed on the 30%-50% profit markup, to ensure the sustainability of product quality and service; Competition-orientated law through the research of similar products prices, combined with its own "Lanzhou University scientific research + clinical verification" differentiation advantage. By researching the price of similar products and combining its own differentiation advantage of "Lanzhou University's scientific research endorsement + clinical verification", the company has set the price in the middle and high end of the range of "higher than ordinary domestic products and lower than imported products", which not only highlights the cost-effectiveness, but also highlights the value of the technology. On this basis, the product price gradient is designed for people with different needs: the basic model meets the basic needs of ordinary patients, the advanced model targets people with high health needs, and the customised model serves patients with special surgeries or basic illnesses, forming a product price model of "basic diversion-advanced profitability-customised value-added".

5.2.2 Promotional activities

For promotional activities, we will mainly focus on "nodal marketing + member stickiness". In holiday promotions, we will combine different scenarios to design themes (e.g. "Healthy Gift Giving" for traditional holidays, "Intestinal Health Popularisation" for industry holidays), and increase purchasing willingness by means of discounts, gift sets, public welfare activities, etc.; and in terms of membership discounts, we will use the following methods In terms of membership benefits, the company provides high-value customers with exclusive rights and benefits (e.g., free medical checkups, customised services) through a grading system (ordinary - silver - gold - diamond, etc.) and a points system, which not only incentivises the conversion of new customers, but also ensures the retention of old customers. The overall promotional strategy avoids the low price competition of "pure price reduction", but enhances customer perception through "value-added" (e.g., health knowledge, exclusive services) to achieve the goal of "promotion without price reduction, value-added to promote conversion The goal is to achieve "promotion without price reduction, value-added to promote conversion".

5.3 Customer Relationships

5.3.1 Customer information management

Management of customer information is the basis of service. We collect customer data (basic information, health status, purchasing behaviour, etc.) through online and offline channels, and build an accurate customer profile through database storage and labeling management (e.g., "perioperative patients", "loyal customers"); and then through demand analysis (e.g., product preferences of patients with different types of surgery), behavior analysis (e.g., purchase path optimization), and value analysis (high/medium/high). Then, through demand analysis (such as the product preferences of patients with different types of surgery), behavior analysis (such as purchase path optimization), value analysis (high/middle/low-value customer stratification), it provides data support for follow-up services and marketing to avoid "blind service".

5.3.2 Full-process service system

Create a full-process service system, covering pre-sales, sales and after-sales, to enhance customer experience and trust. Pre-sales consulting provides professional answers through multi-channel customer service to help customers make decisions; in-sales service focuses on "convenience and efficiency", from order processing, payment to logistics, to ensure a smooth purchasing process and reduce customers' waiting costs; after-sales service solves customers' pain points and dissolves dissatisfaction through the use of guidance, flexible return and exchange, and efficient complaint handling. Dissatisfaction. Especially in the service for post-operative patients, through one-on-one guidance and rehabilitation advice, customers feel the brand temperature of "not only selling products, but also providing health solutions".

5.3.3 Customer Loyalty Enhancement

We will optimize the membership system (expanding exclusive rights and benefits, personalized services), improve the points system (increasing access, enriching the content of redemption), referral reward program (word-of-mouth incentives) and other ways to increase the rate of re-purchase of existing customers while expanding the customer base with the help of referrals from old customers. The entire customer management logic has shifted from "passive service" to "active prediction", providing solutions in advance through data insight into customers' potential needs, and ultimately realising the long-term effect of "improved customer retention rate and strengthened brand reputation". The long-term effect of "customer retention rate increase and brand reputation enhancement" is finally achieved.

5.4 Porter's Five Forces Model Analysis

Porter's Five Forces model was proposed by Michael Porter in the early 1980s for the analysis of competitive strategy, which can effectively analyse the competitive environment of customers. There are five basic forces of competition in an industry, the status and combined strength of which determines the degree of competition in the industry, and thus the ultimate profit potential and flow of capital to the industry, which ultimately determines the ability of a company to maintain a high level of profitability. The five forces are: the bargaining power of suppliers, the bargaining power of buyers, the ability of potential competitors to enter, the substituting power of substitutes, and the ability of competitors in the industry to compete now. Different combinations of the five forces change, ultimately affecting changes in the industry's profit potential and determining the industry's profitability, and pointing out that the core of a company's strategy should lie in choosing the right industry as well as the most attractive competitive position in the industry.

Porter's Five Forces model

5.4.1 Focus on after-sales service

After-sales service is an important part of customer relationship management and one of the key links to maintain valuable customers and explore potential customers, but it is always under-appreciated because it does not directly generate profits. Effective and reliable after-sales service quality can not only make the company sustained low-risk income in the long term, but also more likely to win the favour of consumers. Our company has a special after-sales service department, through professional customer service personnel telephone, door-to-door and other services, for customer groups to solve problems, so that consumers can use the product safely and securely. It can better optimise the consumer's user experience in the process of product use and enhance the consumer's willingness to buy.

5.4.2 Experience marketing based on customer perception

Compared with the traditional marketing mode, experience marketing is a new marketing means to meet the development of the times. Experience marketing adhere to the traditional marketing model, experience marketing is to meet the development of the times a new marketing means. Experience marketing adhere to the customer first, in line with the principle of customer experience, to create a new marketing service model, to bring consumers a better service experience, to better meet the psychological needs of consumers and spiritual needs customer first, in line with the principle of customer experience, to create a new marketing service model to better meet the psychological needs of consumers and spiritual needs to allow customers to have a good feeling about the product, and then actively participate in the purchase. Participate in the purchase. The team takes with the continuous pharmacy cooperation, and sales staff to carry out formal professional training, for consumers to bring more quality service experience, let the product speak for themselves, customer replication, results comparison, detail control. "Let the product speak for itself" Letting the product speak for itself is the core of marketing with the least amount of effort, economy and customer loyalty.

6 Risk Assessment and Response

6.1 Technology R&D Risks

6.1.1 Risk description

Insufficient stability of bacterial strains: metabolically engineered bacteria (including p16090 promoter, OLE1 gene and other components) may lose gene fragments and decrease expression efficiency in long-term storage or complex intestinal environments, resulting in the weakening of the core functions of inhibiting harmful bacteria and regulating inflammation, and failing to meet clinical needs.

Failure of clinical validation: If the product fails to meet the expected targets of "reducing the rate of postoperative intestinal infection by 15% and shortening the time of bacterial colony recovery by 20%" in the phase I/II/III clinical trials, or if there are unforeseen safety problems (e.g., allergic reactions, increased intestinal bacterial colony disorders), it will directly lead to the stagnation of project research and development.

Lagging technology iteration: The technology in the field of synthetic biology is rapidly updating, if competitors are the first to break through more efficient strain editing technology (such as the new generation of CRISPR gene editing tools) or develop multi-target synergistic engineered bacteria, the project's technological advantage will be weakened, and the competitiveness of the product will be reduced.

6.1.2 Degree of Impact

High risk: it directly determines the feasibility of the project. If the core technical problems are not solved, it will lead to sinking of R&D investment and failure of products to be marketed.

6.1.3 Countermeasures

(1) Strain stability optimisation

At the R&D stage: add "simulated intestinal environment (temperature, pH value, bile acid concentration) accelerated aging experiment" to test the genetic stability and activity retention rate of the strain during the 12-month storage period; introduce the "dual promoter regulation system" (p16090 + alternative promoter) to avoid a single problem. The introduction of "dual promoter regulation system" (p16090 + backup promoter), to avoid the loss of efficacy due to the failure of a single element.

Production: Optimise the freeze-drying process by adopting freeze-drying protective agents (e.g. alginate, skimmed milk powder) to increase the survival rate of the strain to over 90%; adopt enteric-coating technology to prevent gastric acid from destroying the strain and ensure that it accurately arrives at the intestine for planting.

(2) Clinical risk control

Pre-research: Jointly with Lanzhou University School of Medicine and the Gastroenterology Department of a tertiary hospital, the company will carry out pre-tests on small samples (50-100 cases) in advance, initially verify the safety and effectiveness of the product, and then adjust the dosage or formula before launching the formal clinical trials.

Process monitoring: establish a "real-time clinical data tracking system", with medical supervisors regularly checking subjects' adverse reactions and laboratory indicators (such as the diversity of intestinal flora and the level of inflammatory factors), suspend the trial in case of abnormality and analyse the reasons, and adjust the trial protocol with the Ethics Committee if necessary.

(3) Construction of technical barriers

Investment in R&D: We invest more than 15% of our annual revenue in R&D, set up a "synthetic biology frontier technology lab" to track the progress of CRISPR-Cas12, base editing and other new technologies, and carry out technology iteration evaluation every 2 years to ensure that the efficiency and efficacy of strain editing is 6-12 months ahead of the industry.

Intellectual property protection: Apply for invention patents in the gene sequence of strains, promoter regulation system, freeze-drying process and other core aspects (expected to apply for 10-15), forming a "technology patent pool", and at the same time, apply for international PCT patents to cover the target markets of Europe, America and the Belt and Road along the border, so as to ensure that the strain can be used in a variety of markets. At the same time, through international PCT patent applications, we will cover the target markets in Europe, America, and along the "Belt and Road" to prevent technology infringement and imitation.

6.1.4 Responsible Departments

R&D Centre, Clinical Cooperation Department, Intellectual Property Department

6.2.2 Impact level

Medium-high risk: directly affects the stability of product supply and profitability level, and may lead to loss of orders and damage to brand reputation.

6.2.3 Countermeasures

(1) Supply chain management

Supplier diversification: screen 2-3 alternative suppliers for core raw materials (e.g., in addition to domestic suppliers for original strains, add 1 new European compliant supplier; co-operate with 2 domestic leading enterprises for lyophilised protective agents), sign a "long-term supply agreement" (agreeing on the minimum supply quantity and quality standards) with the main supplier, and establish an "emergency supply mechanism" with alternative suppliers. "Contingency supply mechanism" is established with alternative suppliers (promise to respond to out-of-stock demand within 48 hours).

Supply Chain Monitoring: Establish "Supply Chain Risk Early Warning System", real-time tracking of suppliers' production capacity, raw material prices, logistics time, assessing suppliers' risk level (high/medium/low) once a month, and reserving 3 months' inventory in advance for high-risk suppliers (e.g. relying on imports, unstable production capacity), so as to reduce the risk of supply interruption.

(2) Production Quality Control

Full-process quality inspection: formulate "production quality control standards (SOP)", test the concentration of live bacteria every 2 hours in fermentation, test the impurity content in purification, and test the number of live bacteria (≥10 billion CFU/pellet) and microbial limit (no pathogenic bacteria) in lyophilisation, and upload all the test data to the "Quality Traceability System" to achieve the goal of "each batch of product is to achieve". Each batch of products can be traced back to specific production personnel, equipment and raw material batches.

Equipment and personnel management: annual investment in production equipment maintenance costs (8%-10% of the original value of the equipment), regular equipment calibration and preventive maintenance (such as fermentation tanks quarterly overhaul); production personnel to carry out "aseptic operation, equipment operation" special training (once a month), only after passing the examination can be employed, and at the same time, the establishment of a "quality incentive fund". At the same time, we have set up a "Quality Incentive Fund" to give bonus incentives to the team with no quality problems.

(3) Cost optimisation

Scale cost reduction: through expanding the production scale (targeting to increase the production capacity from 5 million capsules/year to 30 million capsules/year in 3 years), dilute the fixed costs (e.g., depreciation of equipments, workshop rent); optimise the fermentation process (e.g., adopting the high-density fermentation technology to increase the concentration of bacterial strains by 2-3 times), reduce the consumption of raw materials per unit of product; negotiate with the suppliers of raw materials for the "bulk purchase discount" (when the annual purchase volume exceeds 100 tonnes, strive for 5%-8% price concessions). Discounts" with raw material suppliers (5%-8% price discount when the annual purchasing volume exceeds 100 tonnes).

Cost monitoring: set up "real-time production cost monitoring table", weekly accounting fermentation efficiency, yield rate, raw material loss rate and other key indicators, if the cost of a link exceeds the budget by 10%, immediately organise production, R & D, procurement departments to jointly analyse the reasons (such as whether the low fermentation efficiency is due to the strain formula), formulate an improvement plan and follow up on the implementation of the effect. Effect.

6.2.4 Responsible departments

Production Department, Supply Chain Management Department, Quality Control Department (QC), Costing Department.

6.3 Marketing Risks

6.3.1 Risk description

Consumer trust barrier: some consumers have safety concerns about "genetically engineered bacteria" (e.g. fear of long-term consumption affecting their own intestinal flora, the risk of genetic residues), coupled with the fact that there has been a messy situation in the market of "false labeling" of the efficacy of probiotics, which may lead to scepticism towards the product in the target group (e.g. family members of perioperative patients) and reduced willingness to purchase. For example, families of perioperative patients are sceptical about the product and are less willing to buy.

Competitor squeeze: international brands (e.g. Cohansen, DuPont) with mature brand reputation and clinical data, occupies more than 60% of the domestic mid- to high-end probiotic market; domestic companies (e.g. Keto Bio, Jinqi Bio) to accelerate the layout of the medical-grade probiotic track, if competitors to launch the same kind of perioperative products and through the promotion of low-priced, hospital channel monopoly, will squeeze the market share of the project.

Channel expansion is hindered: medical channels (hospital pharmacy, clinical recommendation) is the core promotional scenario of the project, if it fails to establish cooperation with gastroenterology and surgery departments of tertiary hospitals (e.g., it has not entered the clinical path of hospitals, and the willingness of doctors to recommend it is low), or if the drugstore channel has insufficient exposure due to the high entry fee and poor display position, it will affect the market penetration rate of the product.

6.3.2 Degree of Influence

Medium-high risk: determines the product market acceptance and sales, if it fails to break through the trust barriers and channel barriers, it may lead to the project profitability is less than expected.

6.3.3 Response Measures

(1) Consumer education and trust building

Scientific popularisation: Jointly cooperate with authoritative institutions such as Peking Union Medical College and West China Hospital; explain the strain's mechanism of action (e.g. "activated only in the intestinal bile acid environment, with no systemic side-effects") through medical journals and health videos, and display preclinical safety data (e.g. acute toxicity and long-term toxicity test results).

Evidence-based marketing: Conduct "Real World Study (RWS)", recruit 1000 perioperative patients in 10 tertiary hospitals, publicly track the postoperative infection rate, intestinal recovery time and other data, invite recovered patients to share their experience (produce short videos, casebooks); cooperate with third-party testing organisations (e.g. SGS) to conduct viable bacteria counts, genetic safety data on the product. products for live bacteria count and genetic safety testing, and issue authoritative reports and make them public to consumers.

(2) Differentiated competition

Strengthening product positioning: highlighting the differentiation of the "perioperative" scenario, and emphasising the product's "adaptability to the microecological characteristics of the intestinal tract before and after surgery (e.g., fasting, antibiotic interference)" through the cooperation of clinical pathways in hospitals, as opposed to the "general-purpose probiotics" used by competitors. The product is differentiated from competitors' "general probiotics"; in the publicity, it focuses on "Lanzhou University's scientific research endorsement + multi-centre clinical data", highlighting its technical advantages.

Price and service combination: launch a "product + health management service" package for perioperative patients (e.g., one free intestinal flora test and post-operative rehabilitation guidance with the purchase of one course of product) to enhance the added value of the product; adopt a strategy of "mid- to high-end pricing + exclusive discounts for hospital channels" (e.g., discounts for hospitals). Adopting the strategy of "medium and high-end pricing + exclusive discounts for hospital channels" (e.g. 15% discounts for patients in hospitals) to avoid a low price war with competitors.

(3) Channel Attack

Medical channel breakthrough: set up a "clinical promotion team" (including members with medical background), carry out "industry-university-research co-operation" with hospitals (e.g., jointly carry out perioperative intestinal management research), and promote the product to enter the hospital". Accelerated Rehabilitation Surgery (ERAS)" recommendation catalogue; provide continuing education credit courses (e.g. "intestinal micro-ecology and post-operative rehabilitation" training) for cooperating doctors, to enhance doctors' motivation to recommend the product.

Diversification of channels: online channels through "Jingdong Health" and other platforms to carry out "doctors live consultation + product recommendation" activities, the use of live e-commerce (Shake, Taobao live) to invite medical KOL to explain the advantages of the product; offline pharmacy channels and the old people's pharmacy, The offline pharmacy channel signed a "strategic cooperation agreement" with chain enterprises such as the People's Pharmacy, Yifeng Pharmacy, etc., striving for prime display positions in core shops (e.g., next to the cashier's desk and the prescription drug area), and investing in terminal promotional materials (e.g., display racks and folding pages), while providing product training to the sales staff of the pharmacies to enhance their recommendation ability.

6.3.4 Responsible Departments

Marketing Department, Sales Department, Medical Affairs Department (MSL), Brand PR Department

6.4 Policy Regulatory Risks

6.4.1 Risk Description

Unclear regulatory standards: China has not yet issued clear classification standards for "metabolically engineered probiotics" (e.g. whether they are classified as drugs, health food or food formulated for special medical purposes), and there is a lack of details on the approval process (e.g. requirements for clinical trial filings and post-market regulatory measures), which may lead to a prolongation of the product cycle from research and development to market launch (e.g. approval time exceeding the expected 12-24 months), increasing compliance costs. The lack of details on the approval process (e.g. clinical trial reporting requirements, post-market regulatory measures) may lead to a prolongation of the cycle from product development to marketing (e.g. approval time exceeding the expected 12-24 months), increasing compliance costs.

Risk of policy change: If NMPA tightens its regulatory policy on genetically engineered products (e.g., increasing the sample size requirement for clinical trials, strengthening the monitoring of post-market adverse reactions), or if medical insurance policies exclude medical-grade probiotics from reimbursement, it may affect the clinical promotion of the product and the willingness of patients to pay for the product.

International trade barriers: If the project expands to Europe, America and the "Belt and Road" market at a later stage, the target countries (e.g., the European Union) have strict import approvals for genetically engineered food products (e.g., additional requirements for environmental risk assessment, labelling "genetically engineered"), or due to trade frictions resulting in increased tariffs, will affect the competitiveness of product exports.

6.4.2 Degree of Impact

High risk: directly determines product compliance and market access, and may lead to project delays or export obstruction if policy regulation is unclear or tightened.

6.4.3 Countermeasures

(1) Policy Tracking and Compliance Matching

Policy monitoring: set up a "policy research team" to track the policies related to genetically engineered products and probiotics industry issued by NMPA and NHSC on a weekly basis, establish a communication mechanism with industry associations (e.g., China Association of Pharmaceutical and Biotechnology), obtain the draft of the regulatory rules in advance, and participate in the discussion of policy formulation (e.g., submitting the "Letter of Recommendation for Approval of Metabolically Engineered Probiotics"). Probiotics Approval Proposal Letter").

Classification reporting strategy: according to the product's "medical-grade efficacy (assisting in reducing post-operative infections)", priority will be given to reporting under the category of "pharmaceuticals", and professional CRO companies (e.g. WuXi AppTec) will comb through the information of clinical trial reporting to ensure that it meets the latest requirements of the NMPA. If the approval cycle for drugs is too long, we will prepare the declaration materials for "food formulated for special medical purposes" as an alternative to shorten the listing cycle.

(2) Policy Adaptation

Health insurance and pricing response: if the product is not included in the health insurance, cooperate with commercial insurance companies to develop "perioperative health insurance" (purchase of the product can enjoy insurance discounts), to reduce the pressure on patients' payment; track the health insurance policy dynamics, and apply for inclusion in the local health insurance supplement catalogue (e.g., Guangdong, Zhejiang and other pilot provinces for healthcare reform) when the product has accumulated sufficient clinical data. After the product has accumulated sufficient clinical data, it will apply for inclusion in the local medical insurance supplementary catalogue (e.g. Guangdong, Zhejiang and other pilot medical reform provinces).

Post-market regulatory compliance: establish an Adverse Reaction Monitoring System (ARMS), requiring hospitals and pharmacies to report abnormal reactions during patient use and submit monthly monitoring reports to NMPA; proactively conduct post-market re-evaluation studies (e.g., long-term safety tracking) to satisfy the requirements of the regulatory authorities and to avoid penalties due to regulatory compliance issues.

(3) International Trade Compliance

Target market research: 6-12 months before export, commission local compliance consulting agencies (e.g., CIRS of EU) to research the import policies of target countries on genetic engineering products (e.g., approval process, labelling requirements), and formulate a compliance plan (e.g., carry out environmental risk assessment in accordance with the EU standards, design multi-language labels).

Trade Risk Avoidance: Sign a "Compliance Responsibility Agreement" with the distributor in the export destination to clarify the import approval and tariff declaration obligations of the other party; Reduce trade friction through the "One Belt, One Road" cross-border e-commerce platform (e.g., Ali's international website) and overseas warehouse model. Reduce the risks of logistics delays and tariff increases caused by trade frictions through the "Belt and Road" cross-border e-commerce platform (e.g. Ali International Station) and the overseas warehouse model; purchase "export credit insurance" for export products to cover losses caused by policy changes and tariff hikes.

6.4.4 Responsible Departments

Compliance Department, Policy Research Department, International Trade Department, Health Insurance Department

6.5 Financial Chain Risk

6.5.1 Risk description

Large investment in R&D and production: the project requires investment of more than RMB 200 million in pre-project R&D (preclinical research, clinical trial) and production workshop construction (GMP workshop), which may lead to a break in the capital chain and stagnation of the project if the progress of financing lags behind (e.g., withdrawal of investment by the investor, delay in loan approval).

Cash flow pressure: low sales volume in the early stage of product launch (1-2 years) and high marketing expenses (e.g., hospital channel promotion, consumer education) and fixed costs of production (equipment depreciation, personnel wages) may lead to negative monthly cash flow, which will affect the continuous operation of the project if the expenses cannot be covered by subsequent financing or revenue.

Long investment return cycle: it takes 5-8 years from R&D to profitability of medical-grade probiotics (including clinical trials and market cultivation period). If the investor's expectation of the return cycle is too short, it may ask for an early exit, which will lead to the project facing the risk of equity change or capital withdrawal.

6.5.2 Degree of impact

High risk: determines whether the project can continue to operate, and may lead to the termination of the project if the capital chain is broken.

6.5.3 Countermeasures

(1) Diversified financing

Equity financing: introduce investors in stages, angel investment in seed round (R&D start-up period), VC in medical and healthcare field in A round (clinical trial period), and industrial capital (e.g., strategic investment by pharmaceutical enterprises) in B round (industrialisation period), to avoid dependence on a single investor.

Debt financing: co-operate with state-owned banks (e.g. Industrial and Commercial Bank of China, Bank of China), apply for "special loans for science and technology enterprises" (using intellectual property pledges and government guarantees); docking with government industry funds (e.g. local biomedicine industry funds), and strive for policy low-interest loans to reduce the cost of financing.

Government Subsidies: Declare "National Special Project for the Creation of Major New Drugs" and "High-tech Enterprise Recognition" to strive for R&D subsidies; make use of the local government's supportive policies for medical and healthcare projects (e.g. subsidies for the construction of production workshops and tax exemptions) to alleviate the pressure on capital.

(2) Cash flow management

Budget control: We formulate an annual cash flow budget table, break down revenue targets and costs (e.g., R&D expenses, marketing expenses) by quarter, track the deviation between actual cash flow and budget every month, and make immediate adjustments (e.g., cutting non-core marketing expenses, delaying the purchase of non-essential equipments) if the expenditures exceed the budget by 10%.

Payback acceleration: medical channel adopts "centralised hospital procurement + 30-day payback" model, signing payback agreements with hospitals and specifying late payment penalties; online channel negotiates with e-commerce platforms to shorten the billing period (e.g., from 45 to 30 days), and gives "prepayment discounts" (prepayment discounts) to large-value orders (e.g., purchases by drugstore chains). Prepayment discount" (30% prepayment with 5% discount) to accelerate the return of funds.

(3) Investor Relations Maintenance

Transparent communication: submit monthly project progress reports to investors (including R&D progress, clinical data, sales data), and hold quarterly investor meetings to explain project risks and countermeasures, so as to avoid information asymmetry leading to lack of investor confidence.

Return expectation management: specify the "5-8 year profit cycle" in the financing agreement, and enhance investors' confidence in the long-term return of the project by showing the market scale (e.g. perioperative probiotic market with an annual growth rate of 25%) and competitive advantages (e.g. technological barriers, channel co-operation); set up "milestone performance bet" (e.g. performance bets on R&D progress and sales data); set up "milestone performance bet" (e.g. performance bets on R&D progress and sales data). Setting "milestone performance bets" (e.g. clinical trials reach the target), and giving investors additional equity awards after reaching the target, binding the interests of both parties.

6.5.4 Responsible departments

Finance Department, Financing Department, Investment Relations Department, Budget Management Department

6.6 Risk Monitoring and Continuous Improvement

6.6.1 Risk Monitoring Mechanism

Set up "Project Risk Control Committee", which is composed of responsible persons of R&D, production, marketing, finance and other departments, to hold monthly risk assessment meetings, update the risk level (high/medium/low) against the "Risk List", and track the effectiveness of countermeasures; set up "Risk Early Warning System". A "Risk Early Warning System" has been established to provide immediate warning (reported to the decision-making level within 24 hours) for high-risk events (e.g. abnormal clinical validation, tight financial chain) to ensure rapid response.

6.6.2 Continuous Improvement

Carry out "Risk Review" once every six months to analyse the effect of response to risks that have occurred (e.g. reasons for cost overruns, lessons learned from obstruction of marketing) and update the "Handbook of Risk Assessment and Response Measures"; combine with the technological changes in the industry, changes in policies, and the competitive situation in the market, add new potential risks (e.g. the emergence of new types of competitors, the introduction of new regulatory policies) and formulate a plan, and formulate a "Risk Review". In addition, we will formulate a closed-loop management system of "Risk Identification - Assessment - Response - Review" to ensure the long-term and stable development of the project.

7 Investment and Financial Analysis

7.1 Mobilisation of Funds and Use of Funds

7.1.1 Mobilisation of Funds

The initial registered capital is RMB 1 million from the following sources

Source (of information etc)	Amount ($ million)	Percentage	Clarification
Self-financed by the entrepreneurial team	64	64%	Intellectual Property, Fixed Assets and Cash Equity
Venture capital	8.4	8.4%	Replacement with 7 per cent equity
Strategic Partner Equity	20.4	20.4%	Bringing in industry resources for synergistic development
Bank loan	7.2	7.2%	Debt financing with a profit of 10 per cent above LPR basis
Total	100	100%

When the initial budget was registered, the total registered capital totalled $1 million. Among them, the entrepreneurial team invested 64 per cent of the company's shares with intellectual property, fixed assets and capital, absorbed venture capital of $84,000 with 8.4 per cent of the equity, introduced strategic partners with 20.4 per cent of the equity of $204,000 and attracted the bank to provide a loan to form $72,000 of debt financing.

Subsequent financing plan of this project: Relying on the policy support of the "14th Five-Year Plan" for high-end manufacturing, accelerate the industrialisation of technology. Additional financing through venture capital (VC) and supply chain financial loans, focusing on the construction of small-scale production lines and R & D services transformation. And 80% of the previous year's profit will be used for investment in production line self-research and 20% for market expansion.

7.1.2 Use of funds

The whole project is divided into five periods, the funds will also be mainly used in these five different stages of the specific arrangements for the use of funds specifically allocated as follows:

1. core technology research and development (estimated 400,000 yuan, accounting for 40%)

2. production system construction (estimated at 250,000 RMB, accounting for 25%)

3. preclinical and clinical trials (RMB 250,000, accounting for 25%)

4. Intellectual property rights and compliance layout (estimated $50,000, accounting for 5%)

5. Commercialisation reserve (estimated $50,000, accounting for 5%)

7.2 Financial statement projections

7.2.1 Principal financial assumptions

The major accounting policies adopted and accounting assumptions made by our Company in preparing the financial budget are shown below:

(1) The Company implements the Accounting Standards for Business Enterprises (ASBE) and the Accounting System for Business Enterprises (ASBE);

(2) The accounting year starts from 1 January and ends on 31 December of the Gregorian calendar;

(3) RMB is the local currency of the accounts;

(4) The accrual basis of accounting and the valuation of assets follow the historical cost principle;

(5) Low-value consumables and packages are amortised using the lump-sum amortisation method when they are claimed; fixed assets are recorded at cost at the time of acquisition, and their depreciation is calculated using the average life method (without regard to the net salvage value) over 10 years, and production lines, equipment, etc. are depreciated over 5 years; intangible assets are measured at their actual cost at the time of acquisition, and are amortised in equal instalments over their estimated useful lives from the date of acquisition over a period of 10 years;

(6) Accounts receivable are accrued at 10% of sales revenue, with the first year's receivables collected in the following year; allowance for bad debts is accrued at 5%;

(7) Research and development expenses are extracted at 10% of sales revenue;

(8) Inventory withdrawal rate is 10% of sales quantity;

(9) For dividend payment, no dividend will be paid in the first three years, 20% of net profit will be paid as dividend in the fourth and fifth years, and the legal reserve will be withdrawn at 10% of net profit after tax every year;

(10) Regarding the tax rate, the team belongs to the university students' entrepreneurship, the enterprise income tax implements the policy of "two exemptions and three halves", i.e. the preferential period is calculated from the year of profit, the first year to the second year is exempted from enterprise income tax, the third year to the fifth year according to the statutory tax rate of 25% to halve the enterprise income tax, and enjoy it until the expiry of the period; the enterprise VAT rate is 13%, the urban construction tax is applicable. is 13%, the applicable urban construction tax rate is 7%, the education surcharge tax rate is 3% and the local education surcharge tax rate is 2%;

(11) It is assumed that the accounting policies and accounting estimates will remain stable and will not be changed during the budget preparation period;

7.2.2 Estimation of Costs and Revenues

(1) Product cost breakdown

Direct material cost (unit dose)

Project	Fee/RMB
Strain culture material	200/kg
Probiotics Active Ingredients	100/kg
Adjuvant	50/kg
Wrap	1/piece
Public announcement	1/piece
Total	352

Manufacturing costs ($ million)

Project	Fee/RMB
High-density fermentation equipment	15
Packaging equipment	2.3
Purification equipment	2.7
Total	20

Research and development costs ($ million)

Project	Fee/RMB
Strain development and purification and amplification	6.0
Biosafety Validation	7.6
In vivo validation	6.4
Total	20

(2) Initial cost and expense budget

As shown in the table, the projected capital outflow items include R&D stage, clinical stage, and compliance and commercialisation stage. Inputs in the R&D stage mainly include materials, equipment, personnel, animal experiments, etc., while costs in the clinical stage include trials, filings, etc., and those in the compliance and commercialisation stage include patents, market access and logistics. With the development of the company, it is conservatively expected that the business volume of products will grow steadily by 20% per year.

Initial schedule of expenditures

Form	Project	Amount ($ million)
R&D phase	Materials, equipment, personnel, animal testing	30.0
Clinical phase	Tests, declarations	8.0
Compliance and Commercialisation	Patents	6.0
Access markets	4.0
Logistics	1.0
Total		49.0

(3) Initial Revenue Forecast

The pricing of this product is: Lactobacillus capsules 50/box (12 tablets)

The company's initial revenue will mainly come from co-development with pharmaceutical companies, technology licensing and technical services.

Initial income projection table

(Prepared in $ million)

Project	Amount ($ million)
Collaborative R&D between pharmaceutical companies	50
Technology licensing	50
Technical Services	20
Total	120

Table of income projections over a five-year period(Prepared in $ million)

Project	2026	2027	2028	2029
Collaborative R&D between pharmaceutical companies	50	60	72		86.4
Technology licensing	50	60	72		86.4
Technical Services	20	24	28.8		34.6
Total	120	144	208.8		286.6

7.3 Analysis of the principal financial statements(Prepared in $ million)

Project	2026	2027	2028	2029	2030
Funds	112	132.8	173.1	240.9	340.0
Notes receivable	0	0	0	0	0
Accounts receivable	12.0	14.4	20.9	28.7	38.0
Other receivables	0	0	0	0	36.1
存货	3.6	4.3	6.3	8.6	11.4
Total current assets	120.4	135.6	171.5	225.2	299.4
Long-term receivables	0	0	0	0	0
Long-term equity investments	0	0	0	0	0
investment property	0	0	0	0	0
Original cost of fixed assets	20.0	20.0	20.0	20.0	20.0
Less: accumulated depreciation	(4.0)	(8.0)	(12.0)	(16.0)	(20.0)
Net fixed assets	16.0	12.0	8.0	4.0	0
construction in progress	0	0	0	0	0
intangible asset	18.0	16.0	14.0	12.0	10.0
Less: accumulated amortisation	(2.0)	(4.0)	(6.0)	(8.0)	(10.0)
Net intangible assets	18.0	16.0	14.0	12.0	10.0
Total non-current assets	34.0	28.0	22.0	16.0	10.0
Total assets	154.4	163.6	193.5	241.2	309.4
short term loan	7.2	7.2	7.2	7.2	7.2
accounts payable	3.6	4.3	6.3	8.6	11.4
Employee remuneration payable	2.0	2.4	3.5	4.8	6.4
Taxes payable	1.8	2.2	7.3	11.8	17.2
Total current liabilities	14.6	16.1	24.3	32.4	42.2
long term loan	0.0	0.0	0.0	0.0	0.0
Total liabilities	14.6	16.1	24.3	32.4	42.2
paid-up capital	100.0	100.0	100.0	100.0	100.0
capital surplus	0.0	0.0	0.0	0.0	0.0
unallocated profit	39.8	47.5	69.2	108.8	167.2
Total owners' equity	139.8	147.5	169.2	208.8	267.2
Total liabilities and owners' equity	154.4	163.6	193.5	241.2	309.4

Projected balance sheet

Project	2026	2027	2028	2029	20230
I. Cash flows from operating activities
Cash received from sales of goods and services	127.2	148.3	183.7	246.8	329.6
Tax refunds received	0.0	0.0	0.0	0.0	0.0
Other cash received relating to operating activities	0.0	0.0	0.0	0.0	0.0
Subtotal cash inflow from operating activities	127.2	148.3	183.7	246.8	329.6
Cash paid for goods and services	36.0	43.2	62.6	86.0	114.0
Cash paid to and for employees	25.0	30.0	36.0	43.2	51.8
Taxes paid	0.8	1.0	8.7	14.1	20.6
Payments of other cash related to operating activities	15.0	18.0	21.6	25.9	31.1
Subtotal cash outflows from operating activities	76.8	92.2	128.9	169.2	217.5
Net cash flows from operating activities	50.4	56.1	54.8	77.6	112.1
II. Cash flows from investing activities
Cash paid for construction of fixed assets, intangible assets and other long-term assets	40.0	0.0	0.0	0.0	0.0
Net cash flows from investing activities	40.0	0.0	0.0	0.0	0.0
III. Cash flows from financing activities:
Cash received from absorption of equity investments	100.0	0.0	0.0	0.0	0.0
Other cash paid in relation to financing activities	0.0	0.0	0.0	0.0	0.0
Net cash flows from financing activities	100.0	0.0	0.	0.0	0.0

Projected cash flow statement

(Prepared in $ million)

Project	2024	2026	2028	2029	2030
I. Operating income	144.0	120.0	208.8	286.6	379.9
Business costs	43.2	36.0	62.6	86.0	114.0
Taxes and surcharges	0.9	0.8	1.3	1.8	114.0
R&D upgrade costs	14.4	12.0	20.9	28.7	38.0
System operating costs	0.0	0.0	0.0	0.0	0.0
Sales expense	12.0	10.0	17.4	23.9	31.7
Overheads	18.0	15.0	26.1	35.8	47.5
Site rental costs	0.0	0.0	0.0	0.0	0.0
Financial cost	0.3	0.3	0.3	0.3	0.3
II. Operating profit	55.2	45.9	80.2	110.1	146.0
Non-operating income	0.0	0.0	0.0	0.0	0.0
Non-operating expenses	0.0	0.0	0.0	0.0	0.0
Total profit	55.2	45.9	80.2	110.1	146.0
Income tax expense	0.0	0.0	10.0	13.8	18.3
IV. Net profit	55.2	45.9	70.2	96.3	127.7

Projected income statement

Operating revenues include revenues from the main business, i.e., revenues from the sale of products, healthcare platform draws, as well as other business revenues; operating costs include costs from the main business as well as other business costs. Administrative expenses include salaries of management personnel, utilities for the premises, uncapitalised research and development expenses, other expenses attributable to management, etc. Utilities are incremented in proportion to the increase in employee compensation. Income tax expense is temporarily excluded for the first year as college students are exempted from corporate income tax for the first year of business. The Company is a science-based enterprise, encouraged and supported by national policies, and the tax rate is 15 per cent of taxable income from the second year onwards.

7.4 Analysis of financial indicators

7.4.1 Analysis of Profitability Indicators

Net sales margin climbed steadily from 6.7% at the initial stage to 32.3% in 2028, reflecting the enterprise's precise cost control and the continuous improvement of product value-added. With the continuous optimisation of market expansion and operational efficiency, the operating profit margin has successfully made the leap from loss to profit and remained at a high level, reaching 35.19% in 2028, fully reflecting the remarkable effect of scale effect and cost sharing.

EBITDA margin and return on total assets also perform well, and the continuous growth of both indicates that the enterprise has good operating efficiency and the efficiency of asset utilisation is constantly improving. Through rational resource allocation and efficient operation strategies, the Company has achieved synergistic growth in net profit and asset size, and its profitability has been continuously enhanced. In the future, the Company will continue to deepen cost management, accelerate market expansion and continuously improve product competitiveness to ensure a steady increase in profitability, create greater value for shareholders and lay a solid foundation for the long-term sustainable development of the Company.

(Prepared in tens of thousands of United States dollars)

Norm	2026	2027	2028	2029	2030
Business profit	45.9	55.2	80.2	110.1	146.0
Total profit/operating Profit	45.9	55.2	80.2	110.1	146.0
Sales revenue	120.0	144.0	208.8	286.6	379.9
Net profit ($ million)	45.9	55.2	70.2	96.3	127.7
Amount of assets ($ million)	154.4	163.6	193.5	241.2	309.4
Net sales margin	38.3%	38.3%	33.6%	33.6%	33.6%
Operating profit margin	38.3%	38.3%	38.4%	38.4%	38.4%
EBIT margin	38.5%	38.5%	38.6%	38.5%	38.5%
Return on total assets	29.7%	33.7%	36.3%	39.9%	41.3%

Analysis of profitability indicators

7.4.2 Analysis of Working Capacity Indicators

The turnover days of accounts receivable of the enterprise decreased significantly year by year from 146.42 days in 2026 to reach an excellent level of 14.74 days in 2029, and slightly rebounded to 19.12 days in 2030, but it is still in the leading range of the industry. This trend fully demonstrates the company's precise control and efficient implementation of sales credit management. By optimising credit policies, strengthening customer credit assessment and collection efforts, the company was able to quickly recover funds and greatly reduce the funds tied up in accounts receivable. This not only enhanced the liquidity of funds, but also strengthened the enterprise's ability to deploy funds flexibly, providing solid financial security for the enterprise's daily operations and business expansion.

Inventory turnover days also performed well, gradually optimised from 356.62 days in 2026 to 114.77 days in 2028, and maintained at a stable and low level from 2029 to 2030, with 112.74 days in 2030. This shows that the enterprise has keen market insight and excellent inventory management ability. The enterprise is able to accurately grasp the market demand dynamics and rationally arrange the production and procurement plan, effectively avoiding the backlog and shortage of inventory. On the one hand, it reduces the cost of storage and the risk of inventory decline, and on the other hand, it ensures that the products can be supplied to the market in a timely manner, which improves customer satisfaction and strengthens the competitive advantage of the enterprise in the market.

Project	2026	2027	2028	2029	2030
Accounts receivable turnover days (days)	146.42	95.31	27.75	14.74	19.12
Inventory turnover days (days)	356.62	289.58	114.77	112.5	112.74
Cash cycle (days)	>100	>100	<50	<50	<50

Statement of analysis of operating capacity

7.4.3 Analysis of debt-servicing capacity indicators

The enterprise's performance in terms of solvency is outstanding, both long-term and short-term solvency have shown significant enhancement.

In long-term debt-servicing indicators, the asset-liability ratio has dropped significantly, the equity ratio has continued to be low, and the interest coverage multiple has increased rapidly, demonstrating that the enterprise's financial structure has been optimised continuously, and that its earnings have superb ability to cover the interest on debt, so that the long-term financial risk has been significantly reduced. Among the short-term debt-servicing indicators, the current ratio, quick ratio and cash ratio have been steadily rising, indicating that the enterprise's liquidity is strong and can easily cope with short-term debts.

Overall, with reasonable debt control, capital structure optimisation and profitability enhancement, the company has built up a strong financial foundation and a strong risk-resistant capability, which provides a solid guarantee for its future development and strategic layout, and also sends a positive signal to the market that it is sound and reliable.

(Prepared in $ million)

Norm	2026	2024	2028	2029	2030
Assets ($ million)	154.4	163.6	193.5	241.2	309.4
Liabilities ($ million)	14.6	16.1	24.3	32.4	42.2
Shareholders' equity ($ million)	139.8	147.5	169.2	208.8	267.2
Earnings before interest and tax ($ million)	46.2	55.5	80.5	110.4	146.3
Interest expense ($ million)	0.3	0.3	0.3	0.3	0.3
Currency funds ($ million)	105.4	117.6	145.3	189.3	251.9
Current assets ($ million)	120.4	135.6	171.5	225.2	299.4
Inventory ($ million)	3.6	4.3	6.3	8.6	11.4
Current liabilities ($ million)	14.6	16.1	24.3	32.4	42.2
Gearing	9.5%	9.8%	12.6%	13.4%	13.6%
Equity ratio	0.1	0.11	0.14	0.16	0.16
Interest coverage multiples	154.0	185.0	268.3	368.0	487.7
Current ratio	8.25	8.42	7.06	6.95	7.09
Quick ratio	8.0	8.16	6.8	6.68	6.83
Cash ratio	7.22	7.3	5.98	5.84	5.97

Analysis of solvency indicators

7.4.4 Analysis of Growth Capacity Indicators

The enterprise has strong growth capacity, achieving significant growth in asset size, main business and profit. Despite the fluctuation of some indicators and the slowdown of growth rate in the later stage, the overall development trend is good. In the future, the Company will continue to optimise its investment in fixed assets, strengthen the competitiveness of its core business and enhance its operational efficiency in order to cope with market changes and competitive challenges, ensure sustainable and rapid growth, bring lucrative returns to investors and occupy a more favourable position in the market.

(Prepared in $ million)

Norm	2026	2024	2028	2029	2030
Total assets ($ million)	154.4	163.6	193.5	241.2	309.4
Fixed assets ($ million)	16.0	12.0	8.0	4.0	0.0
Revenue from main operations ($ million)	120.0	14.0	208.8	286.6	379.9
Main profit ($ million)	45.9	55.2	80.2	110.1	146.0
Net profit ($ million)	45.9	55.2	70.2	96.3	127.7
Total asset growth rate		5.96%	18.28%	24.65%	28.28%
Fixed asset growth rate		-25%	-33.33%	-50%	-100%
Growth rate of main business income		20.0%	45.0%	37.25%	32.55%
Total profit growth rate		20.26%	45.29%	37.28%	32.61%
Net profit growth rate		20.26%	27.17%	37.18%	32.61%

Analysis of growth capacity indicators

7.5 Investment analyses

Investment decisions require the use of various indicators to make calculations and judgements. In order to better serve as a reference for investors, the following analyses are carried out in terms of net present value of investment, payback period, embedded rate of return and return on investment. All analyses are based on the full investment within the five-year project implementation period.

7.5.1 Net present value of investment

NPV = $2,559,300,000

After considering the opportunity cost of capital and the risk premium of the investment, we set the company's cost of capital (i.e., discount rate) at 10% . The NPV of the company for the first five years is calculated to be $ million, which is much greater than zero. NPV is a dynamic indicator of the profitability of a project over the life of the investment, and this value indicates that the company has strong profitability over the calculation period. This means that during the normal business period, the company's profitability is good and it is able to achieve the expected investment objectives, and the investment programme is feasible and worth investing in.

7.5.2 Payback period

(Prepared in $ million)

Project	First year	Second year	Third year	fourth year	Fifth year
Projected cash flow ($ million)	50.4	56.1	54.8	77.6	112.1
Cumulative cash flow ($ million)	-49.6	6.5	61.3	138.9	251.0
discount factor	0.9091	0.8264	0.7513	0.683	0.6209
Net present value ($ million)	45.82	46.36	41.17	53.0	69.59
Cumulative net present value ($ million)	-54.18	-7.82	33.35	86.35	155.94

Cumulative net present value of investment projects

(1) Static payback period

Static payback period: Pt = the number of years in which the cumulative net cash flow starts to appear positive - 1 + the absolute value of the cumulative net cash flow of the previous year / the net cash flow of the year in which the positive value appears.

Static payback period of this project = 1.88 years.

As can be seen through the static payback period, the payback period is shorter, indicating that the project can recover costs faster to a certain extent, has a better cost recovery ability, and is more worthy of consideration for investment projects.

(2) Dynamic payback period

Dynamic payback period: Pt = (the number of years in which the present value of cumulative net cash flow appears positive - 1) + the absolute value of the present value of the cumulative net cash flow of the previous year / the present value of the net cash flow in the year in which the positive value appears.

Dynamic payback period of the project = 2.19 years.

It can be seen that under the consideration of the time value of money, the invested capital can be recovered in about 2 years, and the investment risk is relatively controllable, indicating that the project has a certain degree of feasibility.

7.5.3 Embedded Rate of Return (IRR)

As a core indicator of the profitability of an investment project, IRR refers to the rate of return when the project's net present value (NPV) is zero. After rigorous calculation, the IRR of this project reaches 18.7%. By setting the initial discount rate and calculating the corresponding net present value (NPV), if the NPV is positive, then increase the discount rate, if it is negative, then reduce the discount rate, until we find the two neighbouring discount rates (r₁, r₂) that make the NPV converge to the positive and negative values respectively, and the difference between the two values is controlled within the range of 2% - 5%, according to the neighbouring discount rate and the corresponding NPV, through the linear interpolation formula to accurately solve for the IRR. The formula is as follows:

IRR = r₁ + [(r₂ - r₁) × |NPV₁|] / (|NPV₁| + |NPV₂|)

where r₁ is the low discount rate (corresponding to positive NPV₁) and r₂ is the high discount rate (corresponding to negative NPV₂). This value, which far exceeds the industry benchmark rate of return, fully demonstrates the project's excellent income-generating ability and capital appreciation potential. The result shows that the project can realise capital circulation and value creation with high IRR during the whole cycle, which not only strongly covers the cost of capital, but also has significant room for excess return, further confirming the feasibility of the investment project and the attribute of high-value return from the financial point of view.

7.5.4 Investment Return

According to the financial statement's forecast of future operating conditions, the company's profit growth is favourable. In the first three years of operation, in order to fully invest in business expansion and R&D upgrading, the company does not pay dividends for the time being, and focuses its resources on improving core competitiveness.

From the fourth year onwards, the Company started to give back to shareholders. The fourth year net profit of 963,000 yuan, according to 8% dividend 77,000 yuan; the fifth year net profit of 1,277,000 yuan, the dividend increased to 102,000 yuan, five years of dividends far more than the total investment in the project, the return on investment is excellent. This not only enhances the confidence of existing shareholders, but also attracts potential investors. In the future, the company will optimise the dividend policy in accordance with the resolution of the shareholders' meeting, so as to take into account the company's development and shareholders' long-term income.

(Prepared in $ million)

Project	First year	Second year		Third year	fourth year
net profit	45.9		55.2	70.2	96.3
with-profit	0.0		0.0	0.0	7.7

Return on project investment

8 Social Giving Back and Educational Advancement

Engineered bacteria are the "seeds" we sow for health, while public welfare and education are the "soil" for this seed to take root. We always believe that truly valuable innovations should not only solve technical problems, but also go into every corner that needs to be guarded by health, so that the concept of "Digestive Health, Whole Body Health" can be transformed from a plasmid map in the laboratory to a common sense of life that is within the reach of ordinary people. To this end, we have created the three keys of "Beneficial Intestines Miles + Intestinal Health Credits + Blockchain Public Welfare Coin", not only to build a health defence for the disadvantaged groups with technology, but also to use education to make the scientific knowledge become the consensus of all the people, so that every probiotic carries a warmth, and every popularisation of science transmits a power.

8.1 Social Giving Back Programme: Let every probiotic carry "temperature on the chain"

We don't want to do a "give and go" public service, but hope to build a "long-lasting, transparent and win-win" ecosystem - so that children in remote areas will no longer be affected by the imbalance of flora Instead, we hope to build a "win-win" ecosystem - so that children in remote areas will no longer be affected by bacterial imbalance, so that pregnant women will be able to protect the intestinal health of their babies, and so that elderly people in villages will be able to prevent chronic diseases through their daily diet. The starting point of all this is our R&D team's carefully polished "p16090-OLE1-DEFB4A" three-module engineered bacterium, which is not only a product, but also a "technical backbone" for us to carry out public welfare. This strain can accurately "sense" bile acid signals in the intestines, synthesise oleic acid where it is needed to inhibit harmful bacteria, and also regulate immunity and reduce inflammation, just like an "intestinal guardian" who knows when and in what way to guard health. We know that public welfare cannot rely on "feeling", that's why we use the certainty of technology to solve the uncertainty of "the effect is difficult to measure and the help is difficult to sustain" in public welfare, so that every donation can really be put into practice.

8.1.1 Target Group and Layering Model (based on product function, combined with different group classification)

① Layer-1 Children in remote areas: injecting "intestinal energy" for growth

In some rural boarding schools, children's dinner plates often only have simple staple food and pickles, high carbon and low nutritional diet makes their intestinal flora quietly imbalanced -- some children always like to walk in class, some are prone to colds in the changing season, these seemingly "small problems ", in fact, are closely related to intestinal health. In conjunction with UNICEF's Spring Bud Programme, we have focused our attention on boarding students aged 5-9. A bag of engineered bacteria every day is not a simple "nutritional supplement", but a way to help children rebuild the "healthy order" in their intestinal tracts: letting the beneficial bacteria multiply and inhibiting the harmful ones that will steal nutrients and cause inflammation, which can not only alleviate the micronutrient Nutrient deficiencies and a quiet boost to immunity, so they can concentrate better in the classroom and be more energetic on the playground. We also bring simple intestinal care manuals to school teachers and parents, telling them to "add more vegetables to the children" and "let the children drink less sweet drinks", so that health protection is not only a bag of bacterial powder, but also integrated into the daily meals.

② Layer-2 Maternity: for the health of mothers and babies to build "intestinal defences"

For pregnant women, every checkup during pregnancy touches the hearts of the whole family, but few people know that the intestinal health of the mother will directly affect the intestinal development of the baby in the stomach. We've teamed up with the NUEW's Two Cancer Screening Centre to add bowel screening to the maternity check-up "health checklist" - when pregnant women come in for screening, they'll be able to see their baby's gut. - When pregnant women come in for screening, they will be able to complete a "triple micro-ecology" assessment of the oral, vaginal and intestinal tracts, which is like a "full medical check-up" for the mother and baby. If an imbalance of intestinal flora is detected, we will provide pregnancy-specific engineered bacteria free of charge to help mothers regulate the intestinal environment: on the one hand, this will reduce the nuisance of constipation and bloating during pregnancy, and on the other hand, it will also reduce the risk of preterm babies being born with necrotising enterocolitis of the small intestine (NEC). Many mothers-to-be are surprised when they hear for the first time that "mum's gut bacteria affect the baby". Our healthcare professionals will patiently explain: "The baby will be exposed to mum's gut bacteria at birth, and these 'first bacteria' will become the 'foundation bacteria' of the baby's gut. These 'first bacteria' will become the 'basic flora' of the baby's intestinal tract, and to regulate them well now is to lay the foundation for the baby's health."

③ Layer-3 Chronic Diseases of the Elderly: Let the "Happy Canteen" become the "Healthy Canteen"

In many communities and villages, "happy canteens" are a favourite place for the elderly - they don't have to cook for themselves, and they can eat and chat with their old friends. However, we found that many elderly people, because of poor teeth and weak digestion, do not absorb well even after eating, and some are always plagued by constipation and diarrhoea, which slowly dragged into chronic diseases. We tied the probiotic collection to the "meal card": when the elderly come to the canteen every day to eat, they can swipe their card and receive the day's engineering bacteria, which is neither troublesome nor forgettable. What's more, we will adjust the menu together with the canteen chef: according to the local agricultural products, we recommend more vegetables rich in dietary fibre and less heavy oil and salt seasonings. For example, the original canola oil that the canteen always made, we would recommend replacing it with peanut oil with high oleic acid, which not only meets the taste of the elderly, but also helps "add energy" to the beneficial intestinal bacteria. Elderly people often say, "In the past, I always felt bloated after eating, but now that I drink this mushroom powder, my meals smell better and I have strength to walk." This is the effect we want: to make the "Happy Canteen" not only "solve the problem of eating", but also become a "warm harbour" for the elderly to prevent chronic diseases and guard their health.

8.1.2 Implementation mode: "mobile diagnostic and treatment vehicle + digital twin + village demonstration station" trinity, integrated and common construction.

① Mobile micro-ecological diagnosis and treatment vehicle: driving the "intestinal hospital" into the village.

In some remote mountainous areas, villagers have to travel dozens of miles to the county hospital for an intestinal examination, and many people are too lazy to go there even if they are not feeling well, and in the end, minor problems become major problems. 2025, we plan to invest in 30 mobile micro-ecological diagnostic and treatment vehicles to cover 160 key counties in the country's rural revitalisation in three years - these vehicles are like "running vehicles". The vehicles are like "running intestinal hospitals", and they are equipped with a full set of "black technology": 16S rapid inspection equipment can quickly analyse intestinal flora, oleic acid HPLC can measure the health indicators in the blood, the cold-chain box can ensure that the bacterial powder is fresh all the time, and there is also a block-chain system that can record every service. record every service. Villagers don't need to fast, don't need to queue up, 45 minutes to complete the "sampling - testing - intervention - on the chain": first take a little fecal samples, and soon get their own intestinal flora report; if you need to intervene, on the spot you can receive free engineering bacteria; and finally sweep the code to confirm the receipt of the whole process is transparent and efficient. A grandpa said with a smile when he did the test for the first time, "I used to think how scary the gut check was, but I didn't realise I could do it in the village, it's as simple as measuring a blood pressure!"

② Rural Digestive Health Demonstration Station: Make Health Awareness "Visible and Tangible"

Doing health science in the countryside, the most afraid of is "speak unintelligible, listen to remember". We built a digestive health demonstration station in the village, hiding a "little secret": a 1 × 2 metre touchable three-dimensional "flora map". Villagers can see the ranking of their intestinal flora in the county by touching it with their hands - "Mr Wang, you have more beneficial bacteria than 80% of the elderly in the county, keep it up!" "Sister Li, you have a little too much harmful bacteria, remember to eat more sweet potatoes and corn." This kind of "visible health" is much more useful than mere preaching. The demonstration station is not only a "science station", but also a "station to help farmers": we will help villagers test the fatty acid content in locally grown peanuts and sesame seeds, and tell them that "planting high oleic acid peanuts not only fetches a good price, but also helps to Regulate the intestinal tract". There is a village that used to grow only traditional peanuts, but after listening to our advice and switching to high oleic peanuts, not only did the purchase price go up, but the villagers squeezed their own oil and ate it, and there were fewer intestinal discomforts. This is what we want to do "health public welfare + industrial assistance": not only to help villagers guard their health, but also to help villages find ways to increase their income, so that health and affluence fall together.

③ Public Welfare Coin: Let every kindness "circulate up"

The most feared thing about doing public welfare is that "you don't know where to go after donating" and "you don't have the motivation to stick to it even after receiving it". We designed the "Micro-Health Coin" (MHC) public welfare coin to solve this problem: for every box of engineered mushrooms donated, 1 unique piece of information will be generated on the blockchain, and 0.5 MHCs will be minted at the same time. villagers will scan the code when they collect the powdered mushrooms, and the MHCs will be " When villagers scan the code when they receive the mushroom powder, the MHC will be "activated", but it can't be bought or sold, and can only be used to exchange for services - if you save up 3 MHC, you can exchange them for a free medical check-up in the countryside; if you save up 5 MHC, you can let your children participate in a study programme in the city; if you save up 10 MHC, you can exchange them for a door-to-door elderly care service. In order to exchange study places for her grandchildren, a grandma receives mushroom powder on time every day, sweeps the code and punches the card, and also drags her neighbours to participate together: "It can not only regulate the body, but also let the child go to the city to see, this good thing must participate!" This "save public welfare coins for service" model, so that the villagers from "passive acceptance of help" into "active participation in health management", but also so that each donation can form a "cycle of goodwill". The "cycle of goodwill": enterprises donate mushroom powder → villagers get health + public welfare coins → exchange public welfare coins for services → more people are willing to participate → more people get health.

8.1.3 Transparent monitoring system

Transparency is more important than anything else in doing public welfare. We don't want our "good intentions" to be questioned, so we have written "monitoring" into our constitution from the very beginning.

Every year we publish the Digestive Health ESG Report, which not only uses GRI Standards and SASB to standardise the content, but also invites SGS to certify the report - it's like doing a "full audit" of the charity. It's like having a "full audit" of the charity to make sure that every single public welfare expenditure is clear. We also promise that our public welfare expenditure will not be less than 2% of our annual revenue. This is not a "spur of the moment", but a "long term agreement" written into the company's articles of association, so that public welfare will become a "mandatory course" for the development of the company. ".

More reassuring to everyone is the blockchain traceability: we cooperate with BSN Wenchang Chain, from the production of mushroom powder, logistics and transport, to the villagers to sign, take, and return, all five key nodes on the chain. Villagers just need to use their mobile phones to scan the QR code on the mushroom powder packaging, they can see "who produced this bag of mushroom powder", "whether the temperature was up to standard when it was transported here", "who else received the same type of mushroom powder " -- every piece of information can not be tampered with, just like the public good installed "surveillance cameras", so that every good will can be seen and trusted.

8.2 Educational Advancement: Making "intestinal microecology" a "mandatory course" for the whole population

We found that many people do not not pay attention to intestinal health, but "do not know how to pay attention to" - some people take constipation as "fire", and casually take some laxatives; some people feel that "Probiotics are health products, eat or not eat all"; there are also people who have a cold and abuse antibiotics, the beneficial bacteria in the intestinal tract is also "killed" gone. Therefore, the education we want to do is not to "tell knowledge according to the book", but to use the way we like to turn "intestinal microecology" into "common sense" that everyone understands, so that "scientific intestinal care" will not be a problem. "Scientific intestinal care" becomes a "compulsory course" for all people.

8.2.1 IP-based science content - "Intestinal Adventure" series (to better popularise the knowledge of intestinal microecology and microecological capsules to the public)

(1) Short videos: "60-second intestinal knowledge" on Jittery Voice / B-Site / Video

"Doctor, I just had a surgery, can I take probiotics?" "How can I take probiotics after my child has taken antibiotics?" "Is there something wrong with my intestines if my stools are black in colour?" These questions that people usually dare not ask, but especially want to know, are the core content of our "60 seconds of intestinal knowledge" short video. We invited Professor Matthew Frank from Harvard Medical School, the director of gastroenterology at Peking Union Medical College Hospital, registered dietitians, net stars and other KOLs to spend 60 seconds a day to "answer questions and solve puzzles" in easy-to-understand language. For example, when talking about "how to eat after surgery", the doctor will hold a model and say: "After surgery, the intestine is like a child who has just woken up from sleep, and probiotics are like a 'little helper' that can help the intestine to recover its strength quickly, but you have to wait until the doctor says that it is 'okay to eat'. But you have to wait for the doctor to say 'it's okay to eat' before you take it, and you can't just add it on your own." Speaking of "stool colour dictionary", the nutritionist will use cartoon pictures to show: "yellow is normal, black may be eating iron or animal blood, if the black is still shiny, you have to rush to the hospital." These short videos do not have complex terminology, no hard advertising, just like friends around "nagging health", slowly, more and more people began to take the initiative to pay attention to intestinal health -- some people will remind the elderly at home after watching the video "Don't abuse antibiotics"; some people will buy probiotics for their children, first check "whether there is clinical verification", this is what we want to see: let the popular science is not just "brushed to", more able to "remember" and "use".

(2) Meta-universe game: Unreal Engine 5 creates "intestinal world adventure".

"Mum, I beat the 'bad bacteria' in the game today!" This is the proud declaration of many children after playing "Gut World Adventure". We built this meta-universe game in Unreal Engine 5, not to "make kids play games", but to make them quietly fall in love with "gut knowledge" as they play. In the game, the player shrinks down to 1 micron and becomes a "gut explorer", piloting a "spaceship of engineered bacteria" through the folds of the intestinal tract - with energy-giving There are "Oleic Acid Energy Blocks" (which actually talk about the benefits of oleic acid for the intestines), and an army of "Pathogens" (e.g., E. coli, salmonella), which the player has to collect and repel in order to pass the level. After clearing the level, not only can they get "public welfare coins" to redeem the qualification of public welfare donations for rural children, but also get discount coupons for physical bacteria powder. Many parents feedback, after playing the game, children will take the initiative to say "Mom, I want to drink probiotics, like a spaceship to protect the intestinal tract"; some children will also take the game's "flora map" and tell their grandparents that "this is the good bacteria, that one is bad bacteria". We hope to use this "play to learn" approach to let the seeds of intestinal health take root and germinate in the hearts of children, and also let parents make up for the "intestinal knowledge class" in the process of playing with their children.

8.2.2 In-depth education on campus - "Gut Health Credit System".

(1) Curriculum package: conducted in primary and secondary schools, co-edited with People's Health Publishing House, K12 school-based teaching materials (grades 1-9)

"Teacher, where does the food we eat go?" "How do probiotics work in the tummy?" A good textbook can help children find the answers to their wildest questions. In cooperation with the People's Health Publishing House, we have developed a set of "Gut Health School-based Teaching Materials" for children in grades 1-9 - not a thick textbook, but a three-dimensional book that can be played with: Turning to the first page, you can see the teeth in the mouth "crunching" the food, pulling the paper rope, the food will "slide" into the stomach; turn to the page of the small intestine, there is a transparent "fluffy model", you can see how the nutrition is "sucked". Turning to the page about the small intestine, there is a transparent "fluffy model" to see how the nutrition is "sucked" into the bloodstream; there is also a small "engineered bacteria culture box", where children can observe the growth of probiotics every day and record "Today the bacteria liquid has become cloudy The children can observe the changes in the growth of probiotics every day, and record that "today the bacterial liquid has become cloudy" and "today I saw a small colony". In the classroom, the teacher will take the children to do "simulated digestion experiments": using steamed buns to simulate food, using vinegar to simulate gastric acid, so that everyone can see "how the food is digested"; will also organise the "Intestinal Health Theatre", letting the children play the role of the "intestinal health". The children will also organise a "small theatre of intestinal health", letting them play the roles of "beneficial bacteria", "harmful bacteria" and "intestinal mucosa", and understand in the role-playing "why it is important to protect the intestinal tract". In the autumn semester of 2026, we will first pilot the programme in some primary schools, and slowly bring this teaching material to more schools, so that children will know from childhood that "the intestinal tract is our 'second brain', and if we protect it well, our body will be great. "

(2) Credit Bank: In colleges and universities, if you complete the three levels of "online micro-lessons - offline experiments - family sharing", you will get 0.5 credits, which can be offset against 0.2 points of the comprehensive quality evaluation of the college or university.

For college students, "credit" is a very real incentive, but we would like to let them become "little teachers of intestinal health" in the family through the "credit bank". In order to get the 0.5 credits, college students have to complete three tasks: first, they have to watch the microcourse "Intestinal Microecology" online to understand the basic knowledge of bacterial balance and intestinal-brain axis; then, they have to go to the school laboratory to do the "Engineering Bacteria Cultivation Experiment", and operate microscope to observe probiotic bacteria and harmful bacteria. Then we went to the school laboratory to do the "Engineering Bacteria Cultivation Experiment", and operated the microscope to observe the difference between probiotics and harmful bacteria; finally and most importantly, we "shared" what we learnt with our family members: we gave our parents a lecture on "Why you can't take antibiotics casually? Last but not least, share what you've learned with your family: tell mom and dad "why you shouldn't take antibiotics", show grandparents "how to see the number of live bacteria in a probiotic", and make a small video of a "family dialogue on intestinal health". A medical student said after the family sharing, "My mother used to always buy 'net red probiotics' for my brother, and I told her, 'Look at the strain to see if it has a patent and whether there is any clinical data', and she now asks me before she buys it, and she feels that she has really helped her family. she's really helping her family." We hope that in this way, college students can "use" the knowledge they learnt in the classroom, not only to get credits, but also to become a "health bridge" connecting campus and home.

(3) Scholarships: Conducted in colleges and universities, we set up the "Beneficial Bowel Activity Scholarship", which awards 100 college students who have completed 50 hours of community volunteering each year, with a prize of 10,000 RMB/person; we also provide through-train slots for the iDEC and synthetic biology competitions

We set up the "Scholarship for Beneficial Intestinal Activities" not to "reward students with good grades", but to encourage more university students to go into the community and turn their professional knowledge into "practical help ". Students who receive the scholarship are required to complete 50 hours of community volunteer activities first: it may be teaching "bowel care" to the elderly at a community health talk, helping residents register their information on a public health clinic bus, or bringing a "small bowel health class" to children in the community ". We also provide these students with "through-train places" in iDEC and synthetic biology competitions - with a professional research team to guide them in their projects, and the opportunity to turn gut health problems identified in the community into innovative solutions in the competitions. One student found out during his community service that many elderly people didn't know that "probiotics should be kept refrigerated", which led to the failure of the powder, so he designed a "probiotic package with temperature alerts", and won an award in the competition. We hope to use the scholarship to build a "practice - innovation" platform, so that university students can both harvest growth in public welfare and realise the value in research.

8.2.3 Community Co-creation Workshop - Micro-Lab in Box

In the communities of Shanghai and Shenzhen, we have set up "Micro-Lab in Box", where there are no complicated instruments, but only "Oleic Acid Test Boxes" that residents can operate by themselves. There are no complicated instruments here, only "Oleic Acid Test Boxes" that residents can operate themselves -- just as simple as "blood glucose test strips" at home, a drop of cooking oil, wait for a few minutes and then measure the oleic acid content, and scan the code to see the "probiotic strains suitable for you" recommended by the AI. "Auntie Zhang's first visit to the test was to bring a probiotic strain that suited her needs. The first time Auntie Zhang came to the test, she brought the canola oil commonly used at home, and the result showed that the oleic acid content was low. The AI recommended a probiotic that can help the intestines metabolise fat, and she gave feedback after a month's trial: "I used to get diarrhoea when I ate something greasy, but now it's much better... this little box is really useful!"

The operation of the workshop is very interesting: the enterprise pays for the equipment, the community puts up the space, and the university puts up the instructors -- on weekends, student volunteers from the university will come here to be the "little teacher", teaching residents how to use the test box and how to read the ingredient list of the probiotics. We also organise regular "Bowel Health Tea Parties", where we sit together and talk about "how to make bowel-friendly breakfasts for children" and "how to regulate constipation in the elderly", and experienced residents will also share their own "bowel care tips". The data collected from the workshop, such as "which areas have a low intake of oleic acid" and "which strains are more popular among office workers", will in turn help us optimise the strain formulas - it's like a "universal participation" exercise. - It's like a "community-wide R&D" that brings our products closer to everyone's needs, and turns the community into a "family of health co-creation".

8.2.4 Medical-Educational Consortia

(1) Probiotics Evidence-Based Education Centre

For doctors, "updating knowledge" is a lifelong task, especially in the rapidly evolving field of intestinal microecology, where a study published today may change clinical protocols tomorrow. We have teamed up with 10 National Clinical Centres for Digestive Diseases, including Peking Union Medical College, West China University of Science and Technology, and Zhongshan University of Science and Technology, to establish the Probiotics Evidence-Based Education Centre, with the aim of building a "learning and exchange platform" for doctors. The centre will launch 10 online classes and 2 offline classes every year, the content is not "selling products", but the most cutting-edge clinical research: for example, "Data on the application of engineered bacteria in inflammatory bowel disease", "Probiotics and Irritable Bowel Evidence-based Evidence on Probiotics and Irritable Bowel Syndrome", lectured by leading experts in the field, who will also answer doctors' clinical questions on the spot. We will also produce 100,000 patient education brochures for doctors to hand out to their patients. The brochures do not contain jargon, but only practical information such as "how to eat after surgery," "how to choose probiotics," and "what habits hurt the intestines? " These practical contents. A gastroenterologist said, "In the past, when recommending probiotics to patients, I was always afraid of not being able to say how effective they were, but now with the evidence-based data and the manual, I feel more confident in communicating with my patients." Through this centre, we hope that the concept of "scientific use of bacteria" will take root in the medical community, and that doctors will become a "core force" in promoting intestinal health.

(2) Digital platform: develop the "Beneficial Bowel Cloud Classroom" applet, which allows doctors, dietitians and teachers to call up standard PPTs, animations and questionnaires free of charge, with a target of 10,000 registered lecturers, 100,000 course downloads, and 300,000 certificates of passing the online exam by 2027.

Many grassroots doctors, community nutritionists and school teachers want to do intestinal health popularisation, but suffer from "no good materials" - the PPT they make is not professional enough, and the videos they find are not clear enough. We have developed the "IBS Cloud Classroom" app to be a "free popularisation material library": doctors who want to tell patients about the "gut-brain axis" can directly download the PPT, which contains the "gut-brain axis" and the "gut-brain axis". PPT, which has a cartoon demonstration of "how the intestines 'signal' to the brain through the nerves"; dietitians who want to give lectures to community residents can find templates of "probiotic selection guidelines for different populations. " template; teachers want to give students lessons, there is a "small intestinal health experiments" of the operation of the video. What's more, there are online exams in the app -- doctors can take the "Probiotics Clinical Application Qualification Certificate" and teachers can take the "Intestinal Health Popularisation Lecturer Certificate". You can get an e-certificate after taking the test. Our goal is to have 10,000 registered lecturers by 2027, so that these "professional science popularisers" can go into hospitals, communities and schools to deliver scientific knowledge on gut health to every corner. As a community dietitian said, "In the past, I used to feel 'alone' in doing science popularisation, but now with the app, it's like having a 'back-up group', and I feel more confident in doing science popularisation."

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