Entrepreneurship

1. Project budding: Insight into new health needs

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In the fast-paced modern life, however, the problems in the field of health are gradually emerging, especially the widespread spread of abnormal blood lipids and glycemia in the Chinese population, which has constituted a public health problem that cannot be ignored, and urgently needs us to actively respond with innovative product solutions. With increasing awareness of health, cardiovascular disease has become a major public health issue of global concern. Among them, high cholesterol and high blood sugar is an important risk factor for cardiovascular disease, and its management and control have become the focus of public attention. It is in this context that our team has keenly captured the urgent market need for an innovative product that can effectively help reduce cholesterol, prevent diabetes, and promote cardiovascular health. Thus, the "SugarGuardian" project emerged.

2. Concept formation: science and technology integration and health

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We know that relying on traditional dietary adjustments or medication alone has some effect in lowering cholesterol, but it is often accompanied by many inconveniences and limitations. For example, some drugs may be accompanied by side effects such as liver or kidney damage and hypoglycemia, posing new health risks to patients. Therefore, we put forward the research and development concept of "science and technology integration and health", aiming to develop a healthy probiotic product integrating convenience, efficiency and safety through modern scientific and technological means, to help users easily manage cholesterol and blood sugar levels and enjoy a healthier lifestyle.

3. Market research: precise positioning, seize opportunities

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After determining the direction of the project, we conducted in-depth market research. Through data analysis, questionnaire survey, expert interview and other methods, we understand that although there are some cholesterol-lowering products in the current market, most of them have problems such as insignificant effect, inconvenient use or large side effects. At the same time, with the upgrading of the concept of health consumption, consumers demand for high-quality and high-tech health products is increasing. This provides a broad market space and unlimited development potential for our project.

4. Product conception: innovation leads, science and technology enables

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Based on the market research results, we have preliminarily conceived a new intestinal engineering bacteria product integrating intelligent monitoring, personalized dietary advice, scientific exercise guidance and natural ingredients assistance.

Metabolic syndrome is a group of interrelated metabolic disorders, including hypertension, insulin resistance, visceral obesity, reduced HDL cholesterol, and elevated triglyceride levels. Numerous clinical studies have shown that the intestinal microbiota is an important pathogenic factor affecting the metabolic syndrome. In 2004, the Jeffrey Gordon team at the University of Washington found that normal microflora mice had 40 percent higher body fat than germ-free mice. Since then, the altered intestinal flora caused by a high-fat diet has led to an increase in the proportion of intestinal bacteria containing lipopolysaccharide (LPS) in the gut, which is associated with an increased risk of hyperglycemia and hyperinsulinemia. However, a healthy intestinal flora is also protective against metabolic disorders. For example, transfer of the fecal flora of healthy individuals to the gut of patients with metabolic syndrome by duodenal catheterization can alter their gut microbiota and improve their insulin sensitivity. And animal studies have shown that certain strains, such as mucin ackermania, can improve diet-induced obesity, fasting blood glucose, and adipose tissue metabolism. Human studies have shown that the gut flora is tightly associated with lipid profiles: individuals with low gene richness are more likely to develop insulin resistance, high triglycerides, and low-density lipoprotein cholesterol levels. Similarly, these individuals were also associated with high serum leptin, high triglycerides, and high free fatty acids, whereas serum adiponectin and high-density lipoprotein cholesterol levels were lower. Intestinal bacterial richness was negatively correlated with BMI and triglyceride levels and positively correlated with HDL. Specific intestinal bacteria such as Clostridiaceae were reported to have an association with lipid levels or BMI. Through the above literature data, we found that the intestinal microflora plays an important role in metabolic disorders. Therefore, we further reviewed the literature to study the way that intestinal microbiota regulates host lipid metabolism. After the study was found that:

• 4.1

  The gut microbiota regulates host lipid metabolism by affecting bile acid composition and bile acid receptor signaling. Bile acids, a key component of bile, are synthesized by the liver and stored in the gallbladder and later released into the intestine. It mainly emulsifies dietary fat and promotes triglyceride decomposition by lipase. In addition, bile acids also function as signaling molecules involved in glucose and lipid metabolism. Primary bile acids are synthesized by hepatocytes from cholesterol and converted into secondary bile acids by specific enzyme treatment. Thus, changes in gut microbiota affect not only the composition of bile acids but also the bile acid receptor signaling pathway, which in turn play a key role in regulating lipid metabolism.

• 4.2

  Short-chain fatty acids are produced by intestinal bacterial fermentation of non-digestible carbohydrates (such as dietary fiber), mainly acetic acid, propionate and butyric acid. After being absorbed by the intestinal tract, they enter the blood circulation, affecting the metabolism of liver, adipose tissue, skeletal muscle and other peripheral tissues, participating in the regulation of energy, glucose and physiological processes, and related to obesity and related metabolic disorders. The intestinal flora regulates lipid metabolism by affecting the level of short-chain fatty acids produced by metabolism.

• 4.3

  The intestinal flora regulates lipid metabolism by affecting the hormone secretion of enteroendocrine cells (such as L cells). These hormones, such as GLP-1 and GLP-2, play important roles in the intestinal lipid metabolism, and their secretion is regulated by the intestinal microbiota and their metabolites.

• 4.4

  The gut microbiota influences the lipid metabolism by regulating the intestinal barrier function. The intestinal barrier is made up of a variety of cells that can normally prevent harmful substances such as lipopolysaccharides (LPS) from entering the bloodstream. But when the barrier function is impaired, LPS may enter the blood and affect health.

• 4.5

  The intestinal flora can also play a role in regulating lipid metabolism by producing other metabolites. For example, phenylacetic acid is a compound produced by intestinal bacteria breaking down amino acids in food, and the increased level of phenylacetic acid in the blood is closely related to the accumulation of fat in the liver.

On the basis of the above literature, we learned from relevant experts that Insig is a key protein in regulating lipid metabolism, which can bind with the key cholesterol generating protein, SREBP2, to retain it on the endoplasmic reticulum, thus regulating intracellular lipid synthesis. However, the LBK 1 / AMPK axis is able to initiate the Insig upstream signaling pathway, which thus upregulates Insig expression. Butyrate, a short-chain fatty acid secreted by the gut microbiota, targets LBK 1 and phosphorylates AMP-dependent protein kinases to enhance Insig expression. Glucagon-like peptide (GLP-1) is a hormone secreted by intestinal L cells that promotes insulin secretion in the whole body and regulates systemic glucose and lipid metabolism in a glucose concentration-dependent manner. Recent studies suggest that GLP-1 has the potential to act on the LBK 1 / AMPK axis and regulate intracellular adipogenesis.

Based on the literature and the advice of relevant experts, we designed a gut-engineered bacterial product. This product regulates intestinal lipid metabolism by enhancing butyrate synthesis and autocrine GLP-1, thereby by dual targeting of the LBK 1 / AMPK / Insig axis.

This product helps to reduce the risk of cardiovascular disease and improve the quality of life of the patients. For people with diabetes and hypercholesterolemia, this product can not only relieve the disease, but also reduce dietary restrictions, increase the enthusiasm for treatment and promote mental health. For non-diabetic or hypercholesterolemia patients, the product is equally protective against obesity or health promotion.

5. Market decision: hand in hand, create a better future

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By understanding the current industry prospects, we have found that:

• 5.1

  At present, the market of diabetes diagnosis and treatment is large but still relatively blank. The awareness rate and treatment rate of diabetes patients are relatively low, and many patients need to pay more attention to the disease.

• 5.2

  No other drug is perfect in the diabetes market today, All more or less have their own shortcomings (for example, In the oral hypoglycemic agents, The advantages of metformingood hypoglycemic effect and weight loss and cardiovascular protection, However, metformin often causes gastrointestinal reactions, The risk of lactic acidosis; Sulphonylurea agents are effective and cheap, But it is often accompanied by hypoglycemia response, weight gain and secondary failure; High bioavailability of Glinide-like proagents, Short duration of action, But there is hypoglycemia, digestive tract reaction, abnormal liver function; ɑ -glycocoase inhibitors are effective in reducing postprandial blood glucose and are suitable for Asian early diabetic patients, However, ɑ -glycoglycoase inhibitors were dominated by control, Have a certain gastrointestinal tract reaction; GLP-1 receptor agonists protect islet β cells, hypoglycemic and suitable for combination or combination, But the price is more expensive, Mainly by injection, Long-term use such as liraglutide may lead to decreased efficacy and impaired β -cell function; DPP-4 inhibitors protect islet β cells, hypoglycemic and suitable for combination or combination, But the efficacy of prolonged use is uncertain, FDA continuous warning of DPP-4 joint risk and the combination of heart failure risk; SGLT-2 inhibitors use all stages of diabetes, effectively reduce HbA 1 c, reduce weight and reduce blood pressure, But expensive and no cardiovascular evaluation does not impress the FDA, FDA continuous warning of high risk of severe ketoacidosis and urinary tract infection).

• 5.3

  There are many problems to be solved in the hierarchical diagnosis and treatment of chronic disease management.(The complicated treatment of diabetes makes it more difficult to self-manage patients; the basic medical information exchange is not smooth, and the diagnosis and treatment level is uneven;)

• 5.4

  Diet control is difficult, and for many patients, strict diet control and maintaining healthy eating habits are a challenge. Traditional dietary control methods lack personalization and precision to meet the needs of different patients.

According to the above market research, it is urgent to study a new economical drug that can better meet the needs of patients. Our product focuses on the dual targeting technology of engineering bacteria, and accurately acts on the LBK 1 / AMPK / Insig axis to regulate intestinal lipid metabolism in an innovative way. By enhancing Insig expression and self-secrete GLP-1, the project achieved a significant reduction in cholesterol level, significant efficacy and frontier method, far beyond the limitations of traditional cholesterol-lowering drugs, not only has high safety, but also immune regulation effect, showing a high degree of innovation and foresight. In addition, the research direction of this project is broad, not only for the treatment of high cholesterol, but also with the potential to expand the treatment of a variety of metabolic diseases, with a large target group and strong market demand, providing valuable new treatment perspectives and strategies, indicating broad application prospects and far-reaching social value. After fully demonstrated the feasibility and market prospects of the project, we contacted the biopharmaceutical company and submitted a detailed project plan. The senior management of the company spoke highly of the project, and decided to fully support the research and development and marketing of the project. Subsequently, the company quickly set up a cross-department RESEARCH and development team, integrating research and development, marketing, sales and other resources, providing a solid guarantee for the smooth implementation of the project.

6. Product introduction: keep improving, the pursuit of excellence

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This product mainly transforms the plasmids expressing the target gene GLP-1 (glucagon-like peptide) and BCoAT (butyyl / hexyl-CoA) into E. coli and selects the intestinal engineering bacteria expressing only BCoAT and double expressing BCoAT and GLP-1, When performing the high-fat and high-sugar diets, The initiation of the upstream Insig signaling pathway and GLP-1 gene expression via the LBK 1 / AMPK axis to promote insulin secretion, respectively, Enable the engineered bacteria to function to reduce lipid and sugar synthesis, It lays the foundation for the wide application of regulating cholesterol and sugar levels through intestinal microbes. Among them, the gene in engineered bacteria, BCoAT, participates in the synthesis and secretion of butyric acid by encoding butyyl / hexanyl-enzyme A, a key protein in the metabolism of short-chain fatty acid. Burate, as a short-chain fatty acid secreted by intestinal microbiota, can target LBK 1 and phosphorylate AMP dependent protein kinase to enhance the expression of Insig, so that the protein Insig binds the key cholesterol ogenic protein SREBP2 to bind it on the endoplasmic reticulum and regulate intracellular lipid synthesis.

This product uses genetic engineering technology to accurately transform plasmids containing the target gene GLP-1 (glucagon-like peptide) and BCoAT (butyyl / hexyl CoA) into Escherichia coli and achieve stable expression. After the screening process, intestinal engineered bacteria expressing only BCoAT and both BCoAT and GLP-1 were developed.

These gut-engineered bacteria play a vital role in consuming high-fat and sugary foods. By activating the Insig upstream signaling pathway, they activate the LBK 1 / AMPK axis, and promote the expression of the GLP-1 gene, which then stimulate insulin secretion. This complex series of biochemical reactions is designed to effectively reduce the synthesis of lipids and sugars, thus maintaining the metabolic balance in the human body.

The BCoAT gene in engineered bacteria encodes a key short-chain fatty acid metabolic protein, —— butyyl / hexanyl-CoA. This protein plays a central role in the synthesis and secretion of butyric acid. Butyrate, a gut bioactive SCFA with unique bioactivity, accurately targets LBK 1 and enhances Insig expression by phosphorylating AMP-dependent protein kinases. With enhanced Insig expression, it is able to bind to SREBP2, a key protein for cholesterol production, thereby retaining it on the endoplasmic reticulum. This process effectively regulates the intracellular lipid synthesis, allowing the body to maintain a healthier metabolic state in the face of a high-fat and high-glucose diet.

In the development process, we encountered many challenges, such as technical bottlenecks, cost control, user experience optimization and so on. However, the team members always maintain a high sense of responsibility and mission, constantly overcome difficulties and optimize product performance. After several months of hard work, we finally successfully developed the SugarGuardian, and successfully passed the strict quality testing and safety assessments.

Introduction to the experimental operation process: First, the transgenic technology is used to build an engineered probiotics, which will contain the key genes of ISMA, BCoAT and BSH. After the construction, a series of in vitro validation experiments were performed to accurately determine the expression of these target genes. In this process, an exhaustive statistical analysis was performed by changing the pH, temperature, and nutrient content to assess the overall robustness of the strains. In addition, we will culture the strains with BCM and GMM media and test their metabolites to verify the ability of the strains to degrade cholesterol by statistical analysis. This step is essential for determining the strain efficacy. Subsequently, we will introduce mRFP markers and use an oleic acid inducer to distinguish the reporter strain from the acting strain. For these two classes of strains, we will perform in vitro validation and obtain precise results by in vitro analysis. This series of experimental designs is designed to ensure that we can conduct a comprehensive and in-depth evaluation of the performance of the engineered probiotics, providing a solid foundation for subsequent applied research.

7. Market outlook: leading the new health fashion

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The intestinal bacteria that regulate the body glucose metabolism and lipid metabolism have great opportunities and advantages in the market, and at the social level, this mainly benefits from the following aspects:

• 7.1

  Growth potential: The prevalence of metabolic diseases (such as obesity, diabetes, hypertension, etc.) continues to rise and has become a global public health problem. According to the World Health Organization, the number of diabetes patients worldwide has exceeded 416 million and is still growing rapidly. The number of obese patients also continues to increase, and is expected to exceed 30% by 2030. Therefore, the need for regulating glucose metabolism and lipid metabolism continues to grow, and intestinal bacteria, as an innovative method of regulating metabolism, is expected to be an effective treatment for these patients, thus obtaining huge market demand and potential growth.

• 7.2

  Health trends: In recent years, with the improvement of peoples living standards and the enhancement of health awareness, a healthy lifestyle has become a global trend. More consumers are looking to gut health and the impact of the microbiome, and seek products and services that can help regulate metabolism. Products that regulate gut bacteria to promote glucose metabolism and lipid metabolism are in line with health trends and have high market acceptance. Consumers demand for functional foods and health care products continues to grow, providing a favorable market environment for the development of intestinal bacteria products.

• 7.3

  Scientific and technological support: The rapid development of biotechnology and genetic engineering technology has provided technical support for the research and development of intestinal bacteria. Using high-throughput sequencing technology and bioinformatics analysis, scientists can gain insight into the composition and function of gut bacteria to design more targeted and effective regulatory products. Biotechnology-based products have high technological content and innovation, and are expected to be favored by consumers and the market.

• 7.4

  Personalized treatment trend: With the rise of personalized medicine and treatment trends, people are increasingly inclined to accept treatments specific for individual characteristics and needs. The regulatory products of gut bacteria can be customized according to the individual microbiome and metabolic status to meet the personalized needs of different patients. Through personalized treatment, the pertinence and effectiveness of treatment can be improved, and the market competitiveness of products can be enhanced.

• 7.5

  Scientific recognition: The treatment of intestinal bacteria to regulate glucose metabolism and lipid metabolism is gradually recognized and supported by the scientific community. A large number of clinical studies and experimental data have proved the positive effect of gut bacteria in the improvement of metabolic function and health, which provides scientific basis and support for their promotion and application in the market. As more and more scientific research supports the role of gut bacteria in regulating metabolism, consumers trust and recognition of such products will be further enhanced.

  With the increase of metabolic diseases and increasing health awareness, consumers demand for regulating metabolism is constantly increasing, providing a broad market space for the development of gut bacteria products. At the same time, the development of biotechnology and the trend of personalized medicine also provide favorable conditions for the research and development and promotion of intestinal bacteria products. Therefore, intestinal bacteria regulatory products are expected to become an important means for the treatment and health management of metabolic diseases in the future, bringing broad market prospects and business opportunities for enterprises. The market advantage of intestinal engineering bacteria at the user level mainly involves people with glucose metabolism and lipid metabolism related diseases, such as diabetes, obesity, etc. These diseases are often associated with an imbalance in the gut microbiome, and gut-engineered bacteria techniques can have a potential role in improving the symptoms and preventing related complications of these diseases by regulating the composition and function of the gut microbiome. The industry background of intestinal engineering bacteria at the user level is mainly reflected in the response to the personalized health management needs of patients with glucose metabolism and lipid metabolism related diseases, as well as the growth of market demand and product innovation under the background of the promotion of personalized medicine and health awareness. This provides a broad market space and development opportunities for the application of intestinal engineering bacteria technology in the field of disease treatment and health management. At the user level, the industry background of intestinal engineering bacteria is reflected in the following aspects:

  • (1) Increased need for health management: As the number of patients with glucose metabolism and lipid metabolism-related diseases increases, so does the need for individual health management. These patients often require more professional and personalized health management programs to control disease progression and improve quality of life. As a means of personalized health management, intestinal engineering bacteria can provide customized treatment plans according to the characteristics of intestinal microbiome and disease status to meet the needs of patients for health management.
  • (2)The rise of personalized medicine trend: In the field of medical treatment, personalized medicine has become an important development trend. Gut engineering bacteria technology can provide personalized treatment plan according to the characteristics of individual gut microbiome and disease status, and achieve precision medicine. For patients with glucose metabolism and lipid metabolism-related diseases, personalized treatment plans can better meet their health management needs and improve treatment effectiveness and quality of life.
  • (3)The improvement of health awareness: With the improvement of health awareness, more and more patients with diseases begin to pay attention to their own health status, and actively seek for effective health management and treatment plans. As an emerging means of health management, intestinal engineering bacteria have attracted more and more attention and favor from patients. They are willing to try this treatment based on gut microbiome regulation to improve their own health status.
  • (4)Growth in product demand: The increased demand for patients with glucose metabolism and lipid metabolism-related diseases has also led to the development of the intestinal engineering bacteria products market. More and more health managers, medical institutions, and biotechnology companies are beginning to launch gut-engineered bacteria products for this patient population to meet their personalized health management needs. These products cover many aspects ranging from probiotics and prebiotics to customized microbiome regulation protocols to meet the needs of different patients.
  • (5)Policy support: According to the relevant policies in the field of diabetes drugs at various stages, the diabetes drug industry during the 12th Five-Year Plan period; during the 13th Five-Year Plan period, the medical insurance reimbursement and the development of new products for diabetes drugs; since the 14th Five-Year Plan period, the relevant policies focus on the improvement of diabetes outpatient drug protection and the development of new diabetes chemical drugs with new targets and new mechanisms.

  Figure 2: Interpretation of the key policies of the national diabetes medication industry by 2023 (I)

  Source: Foresight Industry Research Institute

  release time	Release department	Policy name	melon point content interpretation	Policy nature
  In July, 2023	The National Medical Insurance Bureau and other 3 departments	Notice on Improving the basic medical Security work for Urban and rural Residents in 2023	We will improve the outpatient support mechanism, coordinate the overall planning of general outpatient services, outpatient chronic diseases (hereinafter referred to as outpatient chronic diseases), and outpatient drug use support for hypertension and diabetes, coordinate policies, form a joint support force, and strengthen the support capacity.	Standard class
  In March, 2023	the State Council	The Implementation Plan for major Projects for the Revitalization and Development of Traditional Chinese Medicine	With the focus on major and difficult diseases such as cardiovascular diseases and infectious diseases, diabetes and infectious diseases, and improving clinical efficacy, a number of project units were selected to jointly tackle key problems in traditional Chinese and western medicine.	Support class
  In March, 2022	the State Council	The 14th Five-Year Plan for the Development of Traditional Chinese Medicine	We will promote a number of intervention programs for TCM treatment, formulate guidelines for the prevention and treatment of diabetes and hypertension with integrated traditional Chinese and Western medicine,	Support class
  In June, 2022	The National Medical Insurance Bureau and other 3 departments	Notice on Improving the Work of Basic Medical Insurance for Urban and Rural Residents in 2022	We will improve outpatient safeguard measures, continue to ensure outpatient rain drugs for hypertension and diabetes, and improve outpatient chronic diseases and special diseases (hereinafter referred to as "outpatient chronic and special diseases *").	Standard class
  In April, 2022	the State Council	The 14th Five-Year Plan for National Health	Comprehensive prevention and control of chronic diseases will be implemented. We will strengthen the construction of national demonstration zones for comprehensive pre-control of chronic diseases, and the search rate will reach 20 percent by 2025. We will improve the comprehensive prevention and treatment capacity of major chronic diseases such as cardiovascular and cerebrovascular diseases, cancer diseases, chronic respiratory diseases and diabetes, strengthen prevention, early screening and comprehensive intervention, and gradually incorporate appropriate techniques for early treatment of eligible venereal diseases into the diagnosis and treatment routine according to regulations. The co-management of "three high levels" (hypertension, hyperglycemia and flat surface lipid) has been promoted, and the standard management service rate of patients with simple surface pressure and type II diabetes has reached more than 65%.	Standard class
  In December, 2021	Ministry of Industry and Information Technology etc. 9 department	The 14th Five-Year Plan	Focus on the development of new chemical drugs with new targets and new mechanisms for the major clinical needs such as the root of the urine disease, as well as the treatment needs of rare diseases.	Support class
  In September, 2021	the State Council	The 14th Five-Year Plan for national Medical Security	Urban and rural residents hypertension and urine disease (hereinafter referred to as "two diseases") outpatient drug guarantee mechanism is generally instant.	Support class
  In April, 2021	National health insurance disability and other 7 departments	Opinions on the Implementation of Consolidating and Expanding the Achievements of Poverty Alleviation through Medical Security and Effectively Connecting the Strategy of Rural Development	We will strengthen the weak board of outpatient guarantee, standardize the outpatient guarantee policy for chronic and special diseases, optimize the outpatient drug protection mechanism for hypertension and hypertension (referred to as "two diseases"), ensure the full coverage of drug protection and health management of patients with "two diseases", and effectively reduce the risk of complications and combination of "two diseases" geese ".	Standard class

  Figure 3: Interpretation of the key policies of the diabetes medication industry at the national level by 2023 (II)

  Source: Foresight Industry Research Institute

  release time	Release department	Policy name	melon point content interpretation	Policy nature
  In June, 2020	The National Medical Insurance Bureau and other 3 departments	Notice on Improving the Basic Medical Security Work for Urban and Rural Residents in 2020	We will strengthen the support of outpatient services, fully implement the mechanism for hypertension and diabetes, and standardize and simplify the identification process of chronic diseases in outpatient clinics. We will implement the new list of national medical insurance drugs, and promote the implementation of negotiated drugs.	Standard class
  In October, 2019	the State Council	Opinions on Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicine	We will focus on cancer, cardiovascular and cerebrovascular diseases, diabetes, infectious diseases, Alzheimers disease and antibiotic resistance, jointly with traditional Chinese and western medicine, and form and promote about 50 diagnosis and treatment plans for integrated Traditional Chinese and Western medicine by 2022.	Support class
  In October, 2019	The National Healthcare Security Administration and other 4 departments	Guiding Opinions on Improving the Drug Guarantee Mechanism for Hypertension and Diabetes in Urban and Rural Residents	To further reduce the burden of medical expenses for urban and rural residents with hypertension and diabetes (hereinafter referred to as "two diseases").	Standard class
  In September, 2019	The National Healthcare Security Administration and other 9 departments	Opinions on the Implementation of Expanding the District and Urban Scope of the Pilot Program of Centralized Procurement and Use of Drugs Organized by the State	It is clear that the national centralized drug procurement and use of centralized quantity procurement will be promoted throughout the country, so that eligible medical institutions across the country can provide high-quality and inexpensive pilot drugs, and further reduce the burden of drug use on the masses.	Support class
  In July, 2019	the State Council	Outline of the Bikang China 2030 Plan	We will implement the strategy of comprehensive prevention and control of chronic diseases, and strengthen the development of national demonstration zones for comprehensive prevention and control of chronic diseases. The management intervention for patients with hypertension and diabetes has been basically covered, and eligible technologies for early diagnosis and early treatment of major chronic diseases such as high disease and stroke have been gradually included in the diagnosis and treatment routine.	Standard class
  In July, 2019	the State Council	Opinions of The State Council on the Implementation of the Healthy China Action Action	We will strengthen the prevention and control of major chronic diseases: cardiovascular and cerebrovascular diseases, cancer, chronic respiratory diseases and diabetes, as well as infectious and endemic diseases.	Support class
  In May, 2019	The National Healthcare Security Administration and the Ministry of Finance	Notice on Improving the Basic Medical Security Work for Urban and Rural Residents in 2019	Outpatient drugs such as hypertension and diabetes will be included in the medical insurance reimbursement, which will be formulated separately.	Standard class
  In April, 2019	the State Council	Opinions on the Implementation of the Division of Labor in Key Work Departments (Government Work Report)	Outpatient drugs such as hypertension and diabetes will be covered by medical insurance.	Standard class
  In January, 2019	the State Council	Notice of The General Office of the State Council on Printing and Distributing the Pilot Program for the Centralized Procurement and Use of Drugs organized by the State	11 cities (4 + 7), including Beijing, Tianjin, Shanghai, Chongqing, Shenyang and Dalian, were selected to select pilot varieties from the generic drugs that passed the quality and efficacy consistency evaluation, and the state will pilot centralized drug procurement and use.	Support class

8. Market strategy: to cure the market, to adapt to the environment

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As the solid backing, the First Hospital of Lanzhou University will fully support our product sales strategy. We have built a multi-level distribution channel system. First, we should deepen the close cooperation with the internal departments of the hospital to ensure the smooth circulation of drugs through the channels of regular medical institutions and maintain a stable supply and demand relationship. At the same time, relying on the professional resources of the hospital, we will provide authoritative technical guidance for clinical application, deepen the market, broaden the boundary of cooperation, jointly explore the new blue ocean of drug application, and jointly explore the new territory of the market.

On the other hand, we actively embrace the changes of the Internet era and flexibly layout our business. Effectively distribute products to this critical link through establishing firm partnerships with drug wholesalers. As a bridge between pharmaceutical companies and retail terminals, wholesalers have extensive network coverage, and can quickly spread our drugs to retail pharmacies, hospitals and various medical institutions, to achieve wide market penetration. This strategy not only makes use of the rich industry resources and channel advantages of wholesalers, but also promotes the diversification of the drug market and the response to the market demand, to meet the drug needs of the majority of patients.

Looking forward to the future, our intestinal probiotics product SugarGuardian will quickly occupy the market with its unique innovative advantages, excellent product performance and considerate user service, and become the preferred brand for consumers to manage cholesterol and promote cardiovascular health.

We firmly believe that through our unremitting efforts and continuous innovation, intestinal probiotics therapy will lead a new health fashion and contribute our own strength to the cause of human health.

9. Industry background analysis

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STP analyse

• 9.1 Market segmentation (Segmentation)

  Location: Diets and lifestyles vary widely between regions, so governments may implement specific policies for obesity and diabetes in some areas. For example, the Mexican government has implemented a beverage tax to reduce the intake of sugary beverages and thus control the prevalence of obesity and diabetes. These policies can influence the local market for the regulation of glucose metabolism and lipid metabolism requirements.

  Living habits: Living habits have an important impact on the composition and function of the gut microbiome. For example, high-fat diet and lack of exercise lead to the development of obesity and diabetes. Therefore, the market segmentation can take into account the different dietary structure and exercise habits of the consumers to better meet their needs to regulate glucose metabolism and lipid metabolism.

  Health status: subdivide the market into consumer groups with different health conditions, such as patients with metabolic diseases such as diabetes and obesity, and healthy people. In this way, we can more accurately target the target market and provide targeted products and services.

• 9.2 Target Market (Targeting)

  Health management markets: In many countries, governments actively advocate for healthy lifestyles and support health management and disease prevention. As an innovative means of health management, gut bacteria can be supported and concerned by the government. For example, the Japanese government encourages the development of healthy food and health care products, which provides market opportunities for intestinal bacteria to regulate glucose metabolism and lipid metabolism products.

  Metabolic disease patient market: For patients with diabetes, obesity and other metabolic diseases, intestinal bacteria can be positioned as an innovative treatment method. Governments and medical institutions may support these patients in trying new treatments to improve their health status and reduce their medical burden.

• 9.3 Positioning (Positioning)

  In the patient market related to glucose metabolism and lipid metabolism-related diseases, gut bacteria can be positioned as an innovative treatment for metabolic disorders and complement existing drug treatments. For example, the U. S. Food and Drug Administration (FDA) has approved some probiotics and prebiotic products to improve the health of the digestive system and regulate metabolic function, providing guidance and support for the positioning of gut bacteria in the market. In the health management market, gut bacteria can be positioned as a health management tool to help people maintain a healthy metabolic state and body functions. It emphasizes its role in promoting overall health, enhancing immunity and improving quality of life, and differentiates itself from other health management products. The government may support and encourage this health management method, providing support for the market positioning of intestinal bacteria products.

Market opportunities and advantages

The intestinal bacteria that regulate the body glucose metabolism and lipid metabolism have great opportunities and advantages in the market, mainly due to the following aspects:

• (1). Growth potential: The prevalence of metabolic diseases (such as obesity, diabetes, hypertension, etc.) continues to rise and has become a global public health problem. According to the World Health Organization, the number of diabetes patients worldwide has exceeded 416 million, and this number is still growing rapidly. The number of obese patients also continues to increase, and is expected to exceed 30% by 2030. Therefore, the need for regulating glucose metabolism and lipid metabolism continues to grow, and intestinal bacteria, as an innovative method of regulating metabolism, is expected to be an effective treatment for these patients, thus obtaining huge market demand and potential growth.

  From the perspective of market segmentation, the target market can be subdivided into different patient groups, such as patients with metabolic diseases such as diabetes, obesity and hypertension, as well as healthy people in potential risk groups. According to different market segments, targeted products and services can be launched to meet the needs of different patient groups.

• (2). Health trends: In recent years, with the improvement of peoples living standards and the enhancement of health awareness, a healthy lifestyle has become a global trend. More consumers are looking to gut health and the impact of the microbiome and seeking products and services that can help regulate metabolism. Products that regulate gut bacteria to promote glucose metabolism and lipid metabolism are in line with health trends and have high market acceptance. Consumers demand for functional foods and health care products continues to grow, providing a favorable market environment for the development of intestinal bacteria products.
• (3). Scientific and technological support: The rapid development of biotechnology and genetic engineering technology has provided technical support for the research and development of intestinal bacteria. Using high-throughput sequencing technology and bioinformatics analysis, scientists can gain insight into the composition and function of gut bacteria to design more targeted and effective regulatory products. Biotechnology-based products have high technological content and innovation, and are expected to be favored by consumers and the market.
• (4). Personalized treatment trend: With the rise of personalized medicine and treatment trends, people are increasingly inclined to accept treatment methods for individual characteristics and needs. The regulatory products of gut bacteria can be customized according to the individual microbiome and metabolic status to meet the personalized needs of different patients. Through personalized treatment, the pertinence and effectiveness of treatment can be improved, and the market competitiveness of products can be enhanced.
• (5). Scientific recognition: The treatment of intestinal bacteria for regulating glucose metabolism and lipid metabolism is gradually recognized and supported by the scientific community. A large number of clinical studies and experimental data have proved the positive effect of gut bacteria on the improvement of metabolic function and health, which provides scientific basis and support for their promotion and application in the market. As more and more scientific research supports the role of gut bacteria in regulating metabolism, consumers trust and recognition of such products will be further enhanced.

With the increase of metabolic diseases and health awareness, consumers demand for regulating metabolism is constantly increasing, providing a broad market space for the development of gut bacteria products. At the same time, the development of biotechnology and the trend of personalized medicine also provide favorable conditions for the research and development and promotion of intestinal bacteria products. Therefore, intestinal bacteria regulatory products are expected to become an important means for the treatment and health management of metabolic diseases in the future, bringing broad market prospects and business opportunities for enterprises.

10. Look to the future, the product application scenarios

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The intestinal bacteria that regulate glucose metabolism and lipid metabolism have great opportunities and advantages in the market. As an innovative means of metabolic regulation, they show great potential and advantages in multiple application scenarios:

• 10.1 Management of diabetic patients

  The management of diabetes patients is a crucial health management work, among which the stabilization of blood sugar level is the most important, and cannot be ignored. In order to effectively respond to the challenge of diabetes, patients can not only strictly follow the doctors diet and medication recommendations, but also consider intestinal bacteria regulatory products as an adjuvant treatment means to further improve the treatment effect. These intestinal bacteria regulatory products optimize the intestinal flora through scientific means and promote the balance of sugar metabolism, so as to help patients to better control blood sugar levels and reduce the disease. Under the professional guidance of doctors, patients can combine intestinal bacteria regulation products with diet and drug therapy to jointly maintain blood glucose stability and improve the quality of life.

• 10.2 Intervention in obesity

  Obese patients often face the problem of abnormal lipid metabolism, which not only affects their health, but also brings a lot of inconvenience to their life. Fortunately, gut-engineered probiotics provide new solutions for this type of patients. These products effectively help patients lose weight and improve their health by regulating the absorption and metabolism of fat. In the process of weight loss, if the patients can combine a reasonable diet and exercise, the intestinal bacteria regulation products can play a better effect and help the patients to reshape their healthy posture.

• 10.3 Preventive health care for healthy people

  For healthy people, intestinal engineering probiotics is undoubtedly an effective means of preventive health care. Through scientific regulation of the gut microbiome, these products can significantly improve the bodys metabolic function, thus reducing the risk of metabolic diseases. In modern society, the pace of life is accelerating and the eating habits are becoming more irregular, which brings great challenges to peoples intestinal health. This product is designed for this problem, they can help people to maintain the health state of the intestinal tract, improve the overall health level, so that people can also maintain a healthy body in the fast pace of life.

• 10.4 Personalized health management

  With the vigorous development of personalized medicine, intestinal engineering probiotic products are gradually showing their unique charm. These products are no longer static and standardized treatments, but can be precisely tailored to the individuals microbiome and metabolic state. Through advanced genetic testing, microbiome analysis and other means, we can have an in-depth understanding of the metabolic characteristics and health needs of each patient, so as to create personalized health management programs tailored for them. This customized service can not only better meet the personalized needs of patients, but also significantly improve the treatment effect and improve the quality of life of patients.

• 10.5 Medical institutions and health care products market

  In medical institutions, intestinal engineering probiotic products are also gradually emerging, becoming an important part of the adjuvant treatment means. They can complement the traditional treatment methods, jointly improve the treatment effect, and bring a better rehabilitation experience for patients. At the same time, in the health care market products, intestinal bacteria regulation products also attract attention, become the right-hand man of consumers to pursue a healthy life. Consumers can choose according to their own health status and needs, suitable for their own intestinal bacteria regulatory products, as a supplement to daily health care, to maintain intestinal health and metabolic balance

11. Pricing strategy: everything is based on cost

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• 11.1 Use dynamic pricing to reasonably set product prices

  In todays fierce competition in the medical market, companies need to price their products flexibly and wisely to ensure that they can meet patient needs while maintaining corporate profitability. Dynamic pricing strategy is an effective way to adapt to the market changes. The core of this strategy is the real-time adjustment of prices in response to various variables of the market, including customer characteristics, geographical differences, purchase timing, market supply and demand conditions, and the actions of competitors. Companies need to deeply study the target market to understand the needs and affordability of different customer groups, as well as the impact of geographical characteristics on price sensitivity. By collecting data on market supply and demand, seasonal fluctuations, and customer purchasing behavior, and using statistical and machine learning techniques, we develop mathematical models to predict the optimal price in different situations. Implement a real-time monitoring system to track sales data, customer feedback and competitor pricing changes, and flexibly adjust prices according to model forecast and market feedback to maximize profit and market share. Dynamic pricing strategy can quickly respond to market changes and improve the market adaptability and competitiveness of enterprises. However, this also requires enterprises to have strong data analysis capabilities and rapid decision-making mechanism. As the healthcare industry evolves and the market environment changes, companies need to continuously optimize and adjust their pricing strategies to achieve long-term success and growth.

• 11.2 Pricing of diabetes drugs based on the cost

  For newly developed diabetes therapy drugs, a cost-based pricing strategy is an effective way to ensure corporate profitability and market competitiveness. First, companies need to accurately calculate all the costs per unit of drug, including raw materials, production processes, quality control, research and development, equipment depreciation, employee wages, and sales and marketing costs. Then, make a deep study of the prices of similar products in the market, determine the price range, and set the price of the products at about 80% of the price of the competitors, in order to attract consumers. This strategy aims to attract consumers at more competitive prices, while ensuring that companies can make reasonable profits and support their long-term development and innovation.

  The cost-based pricing strategy is straightforward and easy to understand and implement. However, it may ignore the dynamics of the market and the perceived value of the customers. Therefore, enterprises need to consider the competitive environment after the expiration of drug patents, and develop long-term price adjustment strategies to adapt to the changes in the market. At the same time, ensure that the pricing strategy complies with local laws and healthcare-related regulations, and regularly evaluate and adjust the pricing strategy based on market feedback and sales data. This integrated approach ensures the flexibility of enterprises in responding to market changes, but also guarantees the cost-based robustness, which provides a solid foundation for the sustainable development of enterprises in the medical market.

12. Porter five force analysis: strategizing, victory

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Porter five-force analysis model was proposed by Michael Porter (Michael Porter) in the early 1980s for the analysis of competitive strategy, which can effectively analyze the competitive environment of customers.

There are five basic competitive forces in the competition in the industry. The situation and comprehensive strength of these five basic competitive forces determine the intensity of competition in the industry, thus determining the final profit potential of the industry and the degree of capital flow to the industry, and all these ultimately determine the ability of enterprises to maintain high returns. The five forces are: the bargaining power of suppliers, the bargaining power of buyers, the ability of potential competitors to enter, the substitution ability of substitutes, and the current competitive ability of competitors in the industry. The change of different combinations of the five forces ultimately affects the change of the profit potential of the industry and determines the profitability of the industry, and points out that the core of the enterprise strategy should lie in the selection of the right industry and the most attractive competitive position in the industry.

Porters five force model

13. Plan for subsequent product upgrade and optimization: continuous evolution of SugarGuardian

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• 13.1 Product cognition and promotion strategy

  • (1) Microbiology science popularization lecture series —— Conference marketing

    Promotion object: relevant hospital related department directors or attending doctors forum Organize a series of lectures, invite industry experts and opinion leaders to share the latest research results on gut microbiota and diabetes treatment, and use these conferences as a platform to show how our products can improve diabetes status by regulating intestinal lipid metabolism;

  • (2) Microbial application and promotion —— personnel marketing and relationship marketing

    Promotion object: communication and cooperation between medical representatives and relevant doctors in relevant hospitals

    Establish long-term cooperation between medical representatives and doctors, and provide detailed product information and clinical data to enhance doctors trust and recognition of the product;

  • (3) Application and promotion of "personalized medicine" —— conference marketing

    Promotion object: communication and cooperation between medical representatives and relevant doctors in relevant hospitals

    "Personalized medicine" application promotion —— personnel marketing, relationship marketing Promotion object: communication and cooperation between medical representatives and relevant doctors in relevant hospitals

    Emphasize how our product can achieve personalized treatment, and adjust the treatment plan according to the patients specific situation.

• 13.2 Network marketing

  • (1) Target audience: Use big data analysis tools to more accurately identify target customer groups, including diabetes patients, medical professionals and health-conscious consumers;
  • (2) Social media marketing: Interact with and promote potential customers through social media platforms (such as TikTok, wechat, Weibo, Facebook, Twitter, etc.). Can release product information, user evaluation and effect display, etc., and create interactive content on social media, such as patient stories, before and after treatment effect comparison, etc., to improve user participation;
  • (3) Content marketing: Through articles, blogs, videos and other ways, to convey more information about products to potential customers, improve the understanding of intestinal flora products in the treatment of diabetes, make high-quality educational videos and animations to explain the relationship between gut microbiota and diabetes, and how our products play a role;
  • (4) Activity planning: In order to attract more target customers, we can organize some online activities, such as gifts, promotions, limited time discounts, lottery, etc., regularly hold online seminars and network broadcast, invite experts to answer audiences questions online, and provide real-time interaction.

• 13.3 Community marketing

  • (1) Encourage interaction and sharing: organize community activities, such as lottery, encourage community members to actively participate, and share their use experience and feelings, increase community activity, design interactive community activities, such as quiz, patient sharing, etc., to encourage community members to share their experience;
  • (2) Cooperate with opinion leaders (KOLs): find opinion leaders in the community or influential people in the industry, and cooperate with them to provide free trial of products, allowing them to evaluate and promote products, thus expanding product influence and popularity;
  • (3) Promotion and sales: product promotion and sales in the community, such as preferential activities, provide gifts, at the same time pay attention to the feedback and community members, according to customer demand constantly optimize products and services, in order to improve the user experience and purchase desire, regular product updates, user feedback and scientific research, establish brand trust.

• 13.4 Cooperate with relevant departments

  In cooperation with medical and scientific research departments, we work closely with medical and scientific research departments under the cooperative government to provide them with experimental and clinical data of intestinal flora in the treatment of diabetes. This cooperation not only helps medical treatment and researchers to have a deeper understanding of the role of related flora in regulating intestinal lipid metabolism, but also promotes the development of skin repair. Our product research has achieved good results and reputation in both laboratory and clinical applications, and has been recognized and recommended by professionals. Through continuous cooperation and exchanges, we believe that we can contribute to the further development of medical care and scientific research fields. At the same time, we will continue to improve and optimize the performance and quality of the products, to contribute to the treatment of diabetes.

  • (1) Deepening scientific research cooperation: establish long-term cooperative relations with scientific research institutions, jointly develop new research projects, explore new mechanisms and applications of intestinal microbiota in the treatment of diabetes, set up special funds to encourage young researchers to participate in the research of intestinal microbiota, and cultivate future scientific research leaders;
  • (2) Strengthen policy advocacy: actively participate in policy discussions, and cooperate with government health departments to promote the formulation of policies and regulations conducive to the treatment of intestinal microbiota. Through policy advocacy, raise public awareness of the importance of intestinal health and create a good social environment for gut microbiota treatment;
  • (3) Educational cooperation expansion: Cooperate with medical schools to develop curricula and textbooks, integrate the knowledge of gut microbiota into the medical education system, and hold seminars and workshops to provide practical opportunities for medical students and young doctors to deepen their understanding of gut microbiota treatment.

• 13.5 Education promotion

  • (1) Professional training Diversified professional training courses at different levels are designed to meet the needs of different medical professionals. Online education platforms are used to provide flexible learning methods, so that medical professionals can receive training anytime and anywhere;
  • (2) Patient education innovation: Use multimedia tools, such as animation and virtual reality, to make patient education more vivid and easy to understand, develop patient education applications, and provide personalized educational content and treatment guidance.

• 13.6 Partnership

  • (1) Deepening cooperation between medical equipment manufacturers: Cooperate with medical equipment manufacturers to develop equipment for use with our products, improve the treatment effect, and explore the application of smart devices in the treatment of diabetes, such as intelligent blood glucose monitoring equipment;
  • (2) Cooperative innovation of medical insurance companies: Cooperate with medical insurance companies to develop insurance products for intestinal microbiome treatment, reduce the economic burden of patients, promote insurance companies to realize the long-term benefits of intestinal microbiota treatment, and improve the insurance coverage.

• 13.7 Academic promotion

  • (1). Participation in academic conferences: actively participate in academic conferences at home and abroad, demonstrated our research results, communicate with peers around the world, organize seminars, and in-depth discuss the application and challenges of intestinal microbiota in the treatment of diabetes;
  • (2). Research paper publication strategy: Develop a research paper publication plan to ensure that our research results can be timely published in high-influence academic journals, and cooperate with academic journals to hold special issues or topics to focus on showing the latest progress of intestinal microbiota treatment.

• 13.8 Patient support program

  • (1). Rich patient support group activities: organize regular patient support group activities, such as health lectures, psychological counseling and rehabilitation training, establish online communities, so that patients can share experience and support each other;
  • (2). Perfect patient feedback mechanism: establish a sound patient feedback mechanism to ensure that patients opinions and suggestions can be collected and handled in time, use patient feedback to optimize products, and improve patient satisfaction and loyalty.

  customer relations

  This project will adopt a customer relationship such as a supply relationship, and the relationship between the project and the customer will develop into a preferred relationship. Our sales team has good relationships with many key players in the enterprise, and we have a large amount of information with our customers. At this relationship level, we will invest more resources to maintain customer relationships, mainly including giving preferential sales policies to key customers, giving priority to their delivery needs, building a team, and strengthening personnel communication between the two sides.

  main activity

  • (1) Continue scientific research, go deep into various other materials, artificial skin, or multifunctional artificial skin, to meet the market demand and expand the diversity of our products.
  • (2) Order purchase, driven by order, our products have a short manufacturing time, we can provide a large number of products in a short time, and there will be a certain inventory for backup
  • (3) Continue to contact with downstream industries and develop our new products through the demand analysis of downstream industries.
  • (4) Participate in relevant professional, industry and academic conferences. Communicate product information with potential consumers at these meetings, and promote and introduce their new drugs to the participants. Professional exhibitions are an important place for enterprises to publicize and promote their products and brands. A large number of enterprises show and look for new products here. In the professional exhibition, the industry enterprises are concentrated, targeted, can directly communicate and docking, publicity and promotion effect is good. Therefore, we can choose to promote it in the relevant conferences in these industries, so that the advantages and characteristics of the products and brands can be quickly understood and recognized in the industry.
  • (5) Submit professional magazines and academic journals in real time according to the scientific research results. Choose professional magazines and academic journals with certain authority, credibility and large circulation in related industries to publicize the image of the enterprise, regularly release some relevant news and product supply information, and also cooperate with relevant research institutions to publish research papers.

14. Marketing goal: look forward to the grand plan

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As shown in the table, the market positioning is divided into initial, middle and late stage, and the sales quantity and target of each stage are different. In the initial stage, the sales quantity is 6000 m 2 / year, and the goal is to expand the market share to more than 3% of the domestic market and moderately develop new markets; the medium-term sales volume to 18000 m 2 / year, the goal is to expand the market share to more than 10% of the domestic market, consolidate the original market and vigorously develop new markets; the sales volume further increase to 20000 m 2 / year, the goal is to pursue high quality development and improve the brand awareness and reputation. With the passage of time, the strategic focus gradually shifted from seizing the market to stabilizing the market and improving brand awareness, the target also gradually improved, and the business continued to expand. Our goal is to promote the products of intestinal colonies treating diabetes as a major alternative to traditional drugs such as insulin to meet the needs of customers and improve their quality of life. Specifically speaking, the marketing objectives can be divided into several aspects:

• (1) Improve brand awareness and education market: the use of social media, online advertising, education seminars and professional conferences, popularize the link between gut microbiota and diabetes treatment, especially the role of butyric acid and GLP-1 in regulating lipid metabolism, emphasize the dual targeting of LBK 1 / AMPK / Insig axis innovation, and its potential in the treatment of diabetes;
• (2) meet the professional medical needs: through cooperation with medical institutions and professional medical personnel, provide detailed product information and treatment plan, ensure that medical professionals understand how to our products by regulating the intestinal lipid metabolism to improve diabetes, collection and analysis of medical professionals feedback, to continuously optimize the product formula and treatment plan;
• (3) Improve patient satisfaction and quality of life: to help customers improve their quality of life and self-confidence by providing high-quality, real and effective diabetes treatment drugs. Maintain customer engagement by providing high-quality after-sales service and solving customer problems;
• (4) Explore new application fields: research and develop the application of intestinal microbiota products in other health fields, such as cardiovascular health, digestive system health, etc., explore cooperation opportunities with beauty makeup, food and medical beauty industries, and expand the concept of intestinal health to a wider market;
• (5) Establish scientific research cooperation and intellectual property protection: cooperate with scientific research institutions to further study the mechanism of butyrate and GLP-1 in lipid metabolism, and how to enhance these roles by engineering bacteria, protect our intellectual property rights, and ensure the uniqueness and competitiveness of our treatment options and technologies in the market;
• (6) Strengthen market positioning and differentiation: to clarify our positioning in the diabetes treatment market, highlight the advantages of our products compared with traditional treatment methods, and attract and retain customers through differentiated strategies, such as unique formulations, innovative treatment solutions and personalized services;
• (7) Continuous monitoring of market dynamics and regulatory changes: pay close attention to market trends, consumer demand and changes in relevant regulations to ensure that our marketing strategy and product development are synchronized with the market;
• (8) Strengthen international cooperation and market expansion: explore opportunities in the international market, establish cooperative relations with medical institutions and scientific research institutions around the world, and adjust our marketing strategies and product characteristics according to the characteristics of the international market to meet the needs of different regions.

15 . Product development plan: technology iteration and function expansion

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We have developed several series of products to make our products more diversified and functional to help us attract more customer resources; and our products have more stability and operability to achieve better reproducible experimental results, enabling us to attract new customers while not easily losing the original customer resources.

Product life cycle curve

The life cycle of this diabetes treatment drug can be divided into the following stages:

• (1) Exploratory period: The main feature of this stage is that it has just been introduced into the market, the research and development and production of products are still relatively preliminary, and the market response is not obvious. At this time, a lot of research and development work needs to be carried out to determine the characteristics and advantages of the product to attract the attention of consumers.
• (2) Growth period: With the gradual entry of products into the market, consumers demand for artificial skin begins to increase, and the sales of products gradually increase. At this stage, enterprises need to gradually expand the production scale, strengthen the brand publicity, improve the quality and performance of products, to meet the market demand.
• (3) Maturity period: At this stage, there are already many competitors in the market, and the market competition is becoming increasingly fierce, and the sales growth rate of products is gradually slowing down. At this point, enterprises need to maintain their existing market share, and develop new markets and products, and constantly improve the quality and added value of products.
• (4) Decession period: After the maturity period, if the enterprise does not update the product and adjust its strategy in time, the market competitiveness of the product will gradually decline, and the sales will begin to decline. At this point, enterprises need to re-examine their products and market strategies, and take measures to adjust their strategies to avoid being eliminated. If the adjustment is not timely or improper, the product may eventually go to the decline period, until it is eliminated.

16. Product marketing promotion and their own brand building

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• 16.1 Precision marketing strategy: According to the market needs of users, formulate precise marketing strategy, and expand the brand influence by participating in various academic conferences and public welfare activities.
• 16.2 Partner expansion: Actively seek cooperation opportunities with medical institutions, health management institutions and other partners to jointly promote the development of the health industry.
• 16.3 Social responsibility fulfillment: actively participate in public welfare activities and health education projects, enhance the brand image and social responsibility, and contribute to the construction of a healthy society.
• 16.4 Participate in related professional, industry and academic conferences. Communicate product information with potential consumers at these meetings, and promote and introduce their technology and products to the participants. Professional exhibitions are an important place for enterprises to publicize and promote products and brands. A large number of enterprises show and look for new products here. In the professional exhibition, the industry enterprises are concentrated, targeted, can directly communicate and docking, publicity and promotion effect is good. Therefore, we can choose to promote it in the relevant conferences in these industries, so that the advantages and characteristics of the products and brands can be quickly understood and recognized in the industry.
• 16.5 Submit professional magazines and academic journals in real time according to the scientific research results. Choose professional magazines and academic journals with certain authority, credibility and large circulation in related industries to publicize the image of the enterprise, regularly release some relevant news and product supply information, and also cooperate with relevant research institutions to publish research papers.

17 . After-sales service and market bargaining

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• Focus on after-sales service level

  After-sales service is an important part of customer relationship management, and also one of the key links to maintain value customers and explore potential customers. However, because it does not directly generate profits, it is always ignored. Effective and reliable after-sales service quality can not only enable the company to obtain low risk benefits for a long time, but also easier to obtain the favor of consumers. Our company has a special after-sales service department, through the professional customer service personnel telephone, door-to-door and other services, to solve problems for customer groups, so that consumers can use the products safely and safely. It can better optimize the user experience of consumers in the process of product use, and improve the purchase intention of consumers.

• Experience marketing based on customer perception

  Compared with the traditional marketing mode, experiential marketing is a brand-new marketing means to cater to the development of The Times. Experience marketing adhere to the traditional marketing mode, experience marketing is a new marketing means to cater to the development of The Times. Experience marketing adhere to the customer first, in line with the principle of customer experience, create new marketing service mode, bring consumers more quality service experience, to better meet the psychological demand and spiritual demand customer first, based on the principle of customer experience, create a new marketing service mode to better meet the psychological demand and spiritual demand of consumers for customers to favor the product, and actively participate in purchase. The team cooperates with continuous pharmacies and carries out formal professional training for sales staff, so as to bring consumers better service experience, let the products speak by themselves, copy customers, compare results and control details."Let the product speak by itself" let the product speak by itself is the most labor-saving, the most economical, the most customer loyalty marketing core.

• Suppliers bargaining power

  When analyzing the bargaining power of suppliers, we need to comprehensively consider the raw material supply, technical cooperation, and engineering bacteria customized production and other aspects. This project focuses on developing an innovative therapy capable of dual targeting of the LBK 1 / AMPK / Insig axis to improve health through modulation of intestinal lipid metabolism. This therapy relies on the engineering of specific strains that efficiently synthesize butyrate and self-secrete glucagon-like peptides (GLP-1).

  • (1). Bargaining power of raw material suppliers

    The core raw materials of this project mainly include various types of media components for engineered bacteria culture, precursor substances of short-chain fatty acids (e. g., butyric acid), and biotechnological reagents for gene editing and bacterial modification.

    Media component supplier: Media is the basis of bacterial growth and reproduction, and its components include carbon sources, nitrogen sources, inorganic salts, growth factors, etc. Because these basic raw materials are widely available in the market, with many suppliers and fierce market competition, the bargaining power of such suppliers is relatively weak. The project team can effectively reduce the procurement cost through multiple price comparison, centralized procurement and other methods.

    Biotechnology reagent supplier: For the high-precision biotechnology reagents required for gene editing and bacterial modification, such as CRISPR-Cas 9 system components, plasmid vectors, restriction enzymes, etc., the market is relatively concentrated and has a high technical content. These reagents are usually produced by a few internationally well-known enterprises, with certain technical barriers and patent protection. Therefore, such suppliers have strong bargaining power. The project team needs to establish a stable cooperative relationship, strive for long-term cooperation concessions, and explore domestic alternatives to reduce the dependence on a single supplier.

  • (2). Bargaining power of engineering bacteria customized production service providers

    The core of this project lies in the customized development of engineered bacteria, including strain screening, gene editing, functional verification and other links. These jobs often require customized services provided by specialized biotechnology companies.

    Technical threshold and professionalism: The customized development of engineering bacteria belongs to a highly specialized service field, with high requirements on technical strength and experimental conditions. The number of companies that can provide such services is limited, and each company has its own unique technological advantage and patent portfolio. Therefore, this kind of service provider has a strong bargaining power. When selecting partners, the project team should give full consideration to its technical strength, past project experience, service quality and other factors, and strive to clarify the ownership of technical achievements, service standards, confidentiality agreement and other terms in the contract, so as to safeguard its own rights and interests.

    Degree of customization and demand specificity: As the engineering bacteria in this project need to have the function of enhancing butyrate synthesis and self-secreting GLP-1, this demand is rare in the market and requires a high degree of customization. Therefore, the service provider may take advantage of its technical advantages and information asymmetry to increase the quotation in the negotiation process. The project team should conduct sufficient market research and demand analysis in advance, and clarify the specific performance indicators and acceptance criteria of the engineering bacteria, so as to occupy a favorable position in the negotiation.

  • (3) . Negotiation capacity for producing short-chain fatty acids and GLP-1 analogues

    Although this project is dedicated to the direct synthesis of butyrate and secretion of GLP-1 by engineered bacteria, exogenous addition of these substances may require functional verification or supplementation at the early stages of development or during the production process. Therefore, the bargaining power of producers of short-chain fatty acids and GLP-1 analogues also needs to be evaluated.

    Market supply and demand conditions: short-chain fatty acids (such as butyric acid) are widely used in agriculture, food, medicine and other fields, and the market supply is relatively sufficient. However, high purity, specific specification of SCFAs may still dominate the market by a few producers, with some bargaining power. For biological products such as GLP-1 analogues, due to the difficult research and development and high production cost, the market supply is relatively tight, and the manufacturers have higher bargaining power.

    Procurement Strategies and Alternatives: In order to reduce the reliance on specific manufacturers and procurement costs, the project team can adopt diversified procurement strategies and establish partnerships with multiple manufacturers. At the same time, actively explore alternatives, such as through chemical synthesis or biological fermentation, to improve the flexibility and stability of the supply chain.

• Buyers chaser bargaining power

  • (1). Market demand and urgency: In todays society, with the improvement of peoples living standards and the enhancement of health awareness, the attention to health management and disease prevention is increasing. The incidence of diseases caused by lipid metabolism disorders, such as obesity, diabetes and cardiovascular diseases, is increasing year by year, which sharply increases the market demand for products that regulate intestinal lipid metabolism. The intestinal lipid metabolism regulation protocol with dual targeting of LBK 1 / AMPK / Insig axis proposed in this project aims to improve lipid metabolism, prevent and treat related metabolic diseases through innovative biotechnology means, so its market demand is highly urgent and realistic. For buyers, such products can not only satisfy their pursuit of a healthy life, but also can effectively address the health risks of lipid metabolism disorders. In particular, individuals who already have metabolic disease or are in high-risk groups have a more urgent demand for such products. This urgent demand makes the buyers often pay more attention to the efficacy and safety of the product when facing the product, rather than the simple price factor;
  • (2). Product uniqueness and differentiation advantages: The engineered bacteria studied in this project have the ability of dual-targeted regulation of intestinal lipid metabolism, which is unique in the current market. By enhancing butyrate synthesis and self-secreted GLP-1, these engineered bacteria are able to act directly on the LBK 1 / AMPK / Insig axis to effectively regulate lipid metabolism for the prevention and treatment of metabolic diseases. This unique regulation mechanism makes the products of this project have significant differentiation advantages, which can meet the unmet needs in the market. The bargaining power of buyers in facing such products with unique and differentiated advantages is often limited. Because of the lack of direct alternatives in the market, it is difficult for buyers to reduce the purchase cost by comparing the cost performance of different products. At the same time, the efficacy and safety of such products need to go through strict clinical trials and verification, buyers tend to choose the verified, the exact efficacy of products, rather than just pursue the price advantage;
  • (3). Professionalism and information asymmetry: Since this project involves complex biotechnology and medical knowledge, buyers are often at a disadvantage of information asymmetry when facing such products. They may lack sufficient expertise to assess the true value and potential risks of a product and can only rely on information such as expert opinion, clinical data and word-of-mouth to make purchasing decisions. This information asymmetry makes the buyer in a passive position in the bargaining process, and it is difficult to effectively play the bargaining power. To overcome the disadvantage of information asymmetry, buyers may seek professional consultation or rely on recommendations from authorities to choose a product. However, this dependence further weakens the bargaining power of buyers, as they often need to make decisions within a limited range of information and accept market pricing;
  • (4). Change in health investment concept: With the popularization of health awareness and peoples pursuit of quality of life, more and more people begin to regard health as a long-term investment. They are willing to invest more resources and funds to improve their health status and prevent the occurrence of disease. This change in health investment concept enables buyers to pay more attention to the long-term benefits and overall value of the products of health-related products, rather than the short-term price advantage. For the products studied in this project, its unique regulatory mechanism and significant efficacy make it one of the important choices for buyers health investment. Buyers are willing to pay higher prices for such products for better health protection and long-term benefits. This change in the health investment concept further weakens the bargaining power of the buyers, because they focus more on the overall value and long-term benefits of the product rather than the simple price factors;
  • (5). Market positioning and brand effect: The products of this project have clear market positioning and brand effect. It is aimed at high-end consumer groups with specific health needs, which tend to have high consumption power and willingness to pay. At the same time, through scientific research and development, strict quality control and marketing and other means, the project product can establish a good brand image and reputation effect, so as to further consolidate its market position. The combination of market positioning and brand effect makes buyers pay more attention to brand awareness and credibility when choosing products. They are more inclined to choose those products with good brand image and reputation effect, because these products often able to provide better product quality and service guarantee. This brand loyalty makes buyers more tolerant and accept market pricing in the face of price factors;
  • (6). Policies, regulations and regulatory environment: In the field of biomedicine, policies, regulations and regulatory environment have an important impact on product pricing and the bargaining power of buyers. With the increasing strength of the national support for the biomedical industry and the strengthening of the supervision, more and more policy dividends and market opportunities have emerged. However, these policy dividends and market opportunities are often accompanied by strict regulatory requirements and approval processes. For the products studied in this project, it needs to go through a strict clinical trial and approval process to ensure the safety and effectiveness of the products. These processes not only increase the development cost and cycle of products, but also limit the quantity and quality level of competition for similar products in the market. In this context, buyers often lack enough bargaining space and ability to face such products, because there are fewer alternatives on the market and uneven quality. At the same time, policies and regulations also have a certain guiding role in the pricing of biomedical products. The government can regulate the market order and protect the rights and interests of consumers by formulating price guiding principles and implementing price supervision and punishment measures. To some extent, these policy measures limit the pricing autonomy of manufacturers and improve the bargaining power of buyers. However, in practice, the bargaining power of buyers is still relatively weak due to information asymmetry and professional restrictions.

18. Clear competitors: know yourself and know your enemy

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• 18.1 Market attractiveness and blue ocean characteristics: In the current health and nutrition field, with the improvement of peoples living standards and increased health awareness, the demand for intestinal health and weight management is increasing. The innovative therapy proposed in this project that dual targets the LBK 1 / AMPK / Insig axis to regulate intestinal lipid metabolism is in line with this market demand, aiming to help and improve lipid metabolism by regulating the intestinal microbiota and its metabolites, so as to control body weight and prevent metabolic diseases. This market area is still in the blue ocean stage, with high growth potential and profit margins, so it is very attractive to new entrants;

• 18.2 Technical threshold and challenges: Despite the huge market potential, the technical threshold involved in this project is not low. The dual targeting strategy requires engineered bacteria not only the ability to efficiently synthesize butyric acid, but also the ability to self-secrete glucagon-like peptide (GLP-1), which requires a deep understanding and mastery of multiple disciplines such as microbial genetics, metabolic engineering and synthetic biology. New entrants will face huge technical challenges to build engineered bacteria in a short period of time.

  Microbial genetic manipulation techniques: To efficiently build and engineer engineered bacteria require skilled manipulation of gene editing tools (such as CRISPR-Cas 9 systems) and the ability to accurately predict and regulate gene expression levels. New entrants need to invest a lot of resources in technology research and development and talent training, in order to gradually establish the corresponding technology platform.

  Metabolic engineering optimization: To enhance butyrate synthesis and GLP-1 secretion capacity, fine regulation and optimization of metabolic pathways in engineered bacteria are required. This involves multiple aspects including a deep understanding of the metabolic network, selection versus overexpression of key enzymes, and efficient removal of metabolic byproducts. New entrants need to go through multiple iterations of optimization to gradually approach optimal performance.

  Safety and efficacy assessment: Any biological therapy applied to the human body must undergo a rigorous safety and efficacy assessment. This includes multiple stages of in vitro experiments, animal experiments, and clinical trials. New entrants need to invest a lot of time and money to complete these assessments and ensure that the safety and effectiveness of their products meet regulatory requirements.

• 18.3 Market entry costs and risks: In addition to the technical threshold, new entrants also need to consider the market entry costs and potential risks.

  R & D investment: To develop competitive products, new entrants need to invest heavily in R & D. This includes talent introduction, equipment purchase, reagent and consumables procurement, and clinical trial costs. For small and medium-sized enterprises, such investment may be a heavy burden. Time cost: from technology research and development to product launch requires multiple stages and long-of research and development process. New entrants need to wait patiently for the process of technological breakthrough and product maturity, and maintain continuous financial and human input in the process. This time cost could be a downside for investors seeking quick returns.

  Market risk: Despite the strong market demand, but the market competition pattern is also constantly changing. New entrants need to pay close attention to market dynamics and competitors strategy adjustments, and develop corresponding market entry strategies to cope with potential market risks. At the same time, the changes in policies and regulations may also have an impact on the market access and pricing strategies of products.

The threat of alternatives

In the field of intestinal lipid metabolism regulation, despite the innovative and potential clinical application of the dual-targeted LBK 1 / AMPK / Insig axis regulation strategy proposed in this project, alert to possible alternative threats on the market. These alternatives may come from different technical pathways, drug forms, or therapeutic concepts, directly or indirectly competing with this project.

Existing drugs and treatment methods:

• (1) Statins: Statins are currently widely used lipid-regulating drugs that reduce the synthesis of cholesterol mainly by inhibiting HMG-CoA reductase. Although its mechanism of action is different from the dual targeting strategy of this project, it has a significant effect in lowering blood lipids and has been widely accepted and recognized. The major statin manufacturers in the market include multinational pharmaceutical giants such as Pfizer (Lipitor) and AstraZeneca (Crestor), which have high market share and brand influence in the market and may constitute direct competition for the project.
• (2) Value drugs: Value drugs are mainly used to reduce triglyceride levels, especially for patients with hypertriglyceridemia. Although its main action targets are different from this project, there is an overlap in the regulation of lipid metabolism. Major manufacturers, such as GlaxoSmithKline (Fenofibrate), have established a stable customer base for their products in the market, which could pose a potential threat to the project.
• (3) Intestinal microbial modulators: In recent years, the relationship between intestinal microbes and health has attracted more and more attention, and a variety of products have appeared on the market to improve lipid metabolism by regulating intestinal microorganisms. These products may include probiotics, prebiotics, or synbiotics, which indirectly affect lipid metabolism by improving the intestinal environment. For example, DuPont, Nestle and other companies have a layout in this field, and have launched a series of related products. Although their direct mechanisms of action are different from those of this project, they may capture market share by meeting the consumer demand for the natural, safe regulation of lipid metabolism.

Research and emerging therapies:

• (1) Gene therapy: With the rapid development of gene editing technology, gene therapy has shown great potential in the field of lipid metabolism regulation. Several biotechnology companies are developing gene therapies for genes involved in lipid metabolism, aiming to regulate lipid levels by directly modifying gene expression. For example, Bluebird Bio, Spark Therapeutics and other companies have actively explored this aspect. Although gene therapy is still in development stage and faces many challenges, its potential efficiency and precision may make it an important competitor in the future market.
• (2) Cell therapy: Stem cells and other types of cell therapy are increasingly widely used in the field of regenerative medicine, some of which also involve the regulation of lipid metabolism. For example, mesenchymal stem cells have been used to treat several diseases because of their immune regulation and differentiation potential, including diseases associated with abnormal lipid metabolism. Some biotech companies such as Mesoblast, Cytori Therapeutics are developing stem cell-based lipid metabolism regulation therapy. These therapies may improve lipid metabolism by promoting tissue repair and metabolic reconstruction.
• (3) New small molecule drugs: New small molecule drugs targeting the LBK 1 / AMPK / Insig axis or other related signaling pathways are under development. These drugs may regulate lipid metabolism through direct inhibition or activation of specific targets, with the advantages of a clear mechanism of action and ease of synthesis and purification. Some small biotech companies and innovative drug companies such as Vertex Pharmaceuticals and AstraZeneca have some layout in this field. These new small-molecule drugs, once marketed, may quickly occupy market share, posing a direct threat to the project.

Cross-border competition and emerging technologies:

• (1) Wearable devices and telemedicine: With the development of the Internet of Things and artificial intelligence technology, the application of wearable devices and telemedicine services in health management is increasingly widespread. Health monitoring devices launched by technology companies such as Fitbit and Apple can monitor users physiological indicators in real time, including blood lipid levels. Although these devices themselves do not directly modulate lipid metabolism, they indirectly influence the market landscape by providing personalized health management and intervention recommendations. Furthermore, telemedicine services enable patients with easier access to professional medical advice and treatment options, potentially reducing reliance on specific treatment products.
• (2) Diet and lifestyle intervention: diet adjustment and lifestyle change are one of the basic measures to regulate lipid metabolism. With the improvement of health awareness, more and more people begin to focus on the effects of dietary structure and exercise habits on lipid metabolism. A large number of food and health care products characterized by low fat, low sugar and high fiber have emerged in the market, as well as App and service platforms advocating a healthy lifestyle. Although these non-drug interventions have a relatively slow effect and require long-term patient adherence, they have the advantages such as low cost and easy to implement, which may have a certain impact on the drug market.

The degree of competition of the competitors in the same industry

In the field of intestinal lipid metabolism regulation, with the deepening of scientific research and continuous technological progress, more and more enterprises began to enter this market, aiming to improve the health of the public through innovative therapies. This strategy of regulating intestinal lipid metabolism by dual-targeting the LBK 1 / AMPK / Insig axis, although unique and innovative, still needs to face fierce competition from the same industry.

• 1. Novo Nordisk (Novo Nordisk)

  

  Novo Nordisk is a worlds leading biopharmaceutical company focusing on the treatment of diabetes and other metabolic diseases. The company has a strong research and development strength and a rich product line in the field of diabetes management, and its insulin analogues (such as Novo ®, Norpeace ®, etc.) occupy an important position in the global market. Although Novo Nordisks current product line focuses on insulin and GLP-1 receptor agonists (such as liraglutide, selmellutide, etc.), the company has been actively exploring new metabolic regulation pathways to meet the growing demand for metabolic diseases.

  In the field of intestinal lipid metabolism, Novo Nordisk may compete indirectly by expanding the scope of application of its GLP-1 therapy. For example, Novo Nordisk, by developing new drugs that can simultaneously promote the secretion and regulation of lipid metabolism, is expected to further enhance its leadership in the treatment of metabolic diseases. Therefore, the project needs to pay close attention to Novo Nordisk to develop an effective competitive strategy.

• 2. Eli Lilly (Eli Lilly and Company)

  

  Eli Lilly is another world-renowned biopharmaceutical company that also has a deep accumulation in the treatment of diabetes and other metabolic diseases. The companys GLP-1 receptor agonist products, such as degrees sugar-peptide (Trulicity®), are well received worldwide and provide effective glycemic control solutions for patients with diabetes.

  Similar to Novo Nordisk, Lilly is also actively exploring new ways to treat metabolic diseases. By strengthening research and development cooperation and expanding the scope of indications, Lilly continuously improves the market competitiveness of its products. In the field of intestinal lipid metabolism regulation, Lilly may use its advantages in the GLP-1 field to develop innovative drugs with multiple regulatory effects, thus forming direct competition with this project.

• 3. AstraZeneca (AstraZeneca)

  

  AstraZeneca is a leading global pharmaceutical company with a product line covering a variety of therapeutic areas, including oncology, cardiovascular, respiratory and metabolic diseases. Astrazeneca has also performed well in the treatment of metabolic diseases, with products such as SGLT 2 inhibitors (such as dagliflozin) offering new treatment options for patients with diabetes. Although Astrazenecas current product line does not directly involve intestinal lipid metabolism regulation, the companys strong research and development capabilities and rich product line layout give it the potential to quickly enter new areas. In the future, AstraZeneca may expand its business scope in the field of metabolic disease treatment through acquisition, cooperation or independent research and development, so as to form a competitive relationship with this project.

• 4. AbbVie (AbbVie)

  

  AbbVie is a global research-based biopharmaceutical company specializing in the fields of immunology, oncology, neuroscience, and aesthetics. While AbbVies core business is not directly focused on metabolic disease treatment, its deep accumulation in the biopharmaceutical sector allows it to quickly respond quickly to market changes and develop new therapeutic products.

  In the field of intestinal lipid metabolism regulation, AbbVie may introduce innovative therapies to meet the market demand through cross-border cooperation or independent research and development. For example, AbbVie may work with companies focused on gut microbiological research to develop biologics or engineered bacterial products that can modulate gut lipid metabolism. This cross-border cooperation will not only help AbbVie to enter new markets quickly, but also may bring direct competitive pressure to the project.

• 5. Start-ups and innovative biotechnology companies

  In addition to the worlds leading pharmaceutical companies, a large number of start-ups and innovative biotechnology companies are actively engaged in the field of intestinal lipid metabolism regulation. These companies tend to have more flexible R & D mechanisms and faster decision-making processes, and are able to quickly respond to market demand and launch innovative products. For example, some start-ps focusing on synthetic biology, gene editing, or gut microbial research, may be developing engineered bacterial products that enhance butyrate synthesis or self-secretion of GLP-1. These products may form direct competition with the dual targeting strategy of this project and have an impact on market share. In addition, some innovative biotech companies may also introduce more competitive innovative therapies by introducing advanced technologies from other fields into the field of intestinal lipid metabolism regulation.

19. Background environment analysis, clear positioning

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• 1.Domestic policy environment

  In recent years, with the in-depth implementation of the national strategy for healthy China and the continuous improvement of the national health awareness, the policy support for the management of chronic diseases and the prevention and treatment of metabolic diseases has been increasingly strengthened. In the field of intestinal lipid metabolism regulation, a series of policy guidance provide a good external environment for the R & D and application of this project.

  Incentive policies for pharmaceutical innovation: Since 2015, the state has greatly stimulated the innovation vitality of domestic pharmaceutical enterprises through the special project of major new drug innovation, drug administration reform, and the opening of the capital market (such as the 18A of the Hong Kong Stock Exchange and the Science and Technology Innovation Board). These policies not only lower the threshold for new drug research and development, but also accelerate the transformation of innovative achievements, providing financial support and market access convenience for the research and development of dual-targeted LBK 1 / AMPK / Insig axis to regulate lipid metabolism technology.

  Healthy China strategy: The state clearly puts forward the implementation of the healthy China strategy, and puts the peoples health in the strategic position of priority development. This strategy emphasizes prevention first, focuses on full life-cycle health management, and encourages the application of scientific and technological innovation in health services. In response to this strategy, the dual targeted regulation technology of this project aims to improve the national lipid metabolism status and reduce the risk of chronic diseases such as cardiovascular and cerebrovascular diseases. Medical insurance cost control and rational drug use policy: In the face of increasing medical expenses, the country continues to implement the medical insurance cost control policy, aiming to optimize the allocation of medical resources and reduce unnecessary medical expenses. By regulating intestinal lipid metabolism, this project is expected to help patients reduce the treatment costs of related diseases caused by dyslipidemia, which is in line with the spirit of medical insurance cost control, and also in line with the principle of rational drug use, to reduce the side effects of drugs and improve the treatment effect.

• 2. Social and cultural environment

  With the improvement of living standards and the change of lifestyle, the problem of lipid metabolism disorder among Chinese residents is becoming increasingly prominent, and the incidence of metabolic diseases such as obesity and hyperlipidemia is increasing year by year. This change has not only affected personal health, but also brought great pressure on the social health security system. Therefore, there is an urgent need for the products and technologies that can effectively regulate lipid metabolism and prevent metabolic diseases.

  Health awareness: modern people pay more attention to health, and more and more people begin to pay attention to lifestyle adjustments such as healthy diet and moderate exercise. The emergence of dual targeted regulation technology just meets the needs of consumers for health management, and is expected to become a part of a healthy lifestyle.

  Popularization of science education: With the development of online media and the increasing popularity of health science education, the public has a deeper understanding of the concepts of lipid metabolism and intestinal flora. This has laid a good foundation for the marketing and consumer education of the project products.

• 3. Technology competition environment

  In the field of intestinal lipid metabolism regulation, although many drugs and therapies have been applied in the clinic, the dual technology of targeting the LBK 1 / AMPK / Insig axis still has significant innovative and differentiated advantages.

  Technological innovation advantages: Through genetic engineering and cell engineering technology, this project has developed an engineered bacterium that can enhance the synthesis of butyric acid and self-secretion of GLP-1, realizing the dual targeted regulation of intestinal lipid metabolism. This innovative technology not only improves the regulation efficiency, but also reduces the side effects of traditional drugs, and has a broad market prospect.

  Market competition pattern: Although there are a variety of products regulating lipid metabolism in the market, most of them focus on a single target or mechanism. The technical barriers of this project are relatively high, and no direct competitive products appear in the market. However, with the maturity of the technology and the improvement of the market awareness, it is expected that more enterprises will enter the field in the future, and the market competition will gradually intensify.

  Coping strategy: In order to cope with the possible future competition, this project needs to continuously increase the investment in R & D, optimize the performance and stability of engineering bacteria, and improve the safety and effectiveness of products. At the same time, to strengthen the marketing and brand building, to improve consumers awareness and trust of the project products. In addition, it actively seeks cooperation with medical institutions, scientific research institutions and upstream and downstream enterprises of the industrial chain to jointly promote the clinical application and industrialization process of technology.

20. financial forecasting

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capital composition

The total registered capital of the organization is 10 million yuan. The source structure of equity capital and debt is shown in the following table:

Among them, the entrepreneurial team invested in intellectual property rights, fixed assets and capital, accounting for 82.16% of the companys shares, used 6.2% equity to absorb 2 million yuan, introduced strategic partners to buy 1 million yuan with 11.64%, and attracted banks to provide loans to form 1 million yuan of debt financing.

Main Financial Assumptions

The calculation process specifically makes the following assumptions:

• (1) Full investment assumption. It is assumed that when determining the cash flow of the project, only the entire investment movement is considered, without distinguishing the specific forms of cash flow from the funds of the venture capital company. That is, make all the actual existing funds as the capital of the operation of the company.
• (2) Deterministic hypothesis. Suppose that the price, cost, and income tax rates related to the project cash flow are all known constants.
• (3) Financial feasibility analysis hypothesis. Assuming that the investment decision is from the standpoint of the enterprise investors, the investors determine the cash flow to conduct the feasibility study of the project, the project has the feasibility of national economy and technical feasibility.
• (4) The hypothesis of investment funds during the construction period. Whether the original investment of the project is one investment or two investment, it is assumed to be invested during the construction period, except as otherwise specified.
• (5) Time-point index assumptions. In order to facilitate the use of the time value of funds, whether the value index involved in the time index of the cash flow is the timing index; at the end of the year of the construction year, the income, cost, amortization, profit, tax and other items occur at the end of the year; and the final scrapping or liquidation of the project occurs at the endpoint.
• (6) Investment income analysis: According to the development plan of the company, the following objectives, the preparatory work of the Company shall be gradually improved in the initial construction stage to purchase fixed assets; since the initial operation stage, the advanced price is more reasonable than similar products; with the normalization of the Company, the Company shall expand production scale and reinvest.
• (7) Accounting system: The company implements the Accounting System for Business Enterprises.
• (8) Fiscal year: one fiscal year is from January 1 to December 31 of the Gregorian calendar year.
• (9) Accounting standard currency: RMB is the bookkeeping standard currency.
• (10) Accounting basis and valuation principle: take accrual basis as the accounting basis and historical cost as the valuation principle.
• (11) Depreciation of fixed assets: the plant construction is 3%; the equipment is 3% for 10 years; vehicles and office equipment are 5 years; the residual value is 3% and the residual value of office equipment is excluded.
• (12) Long-term amortized expenses: the companys decoration expenses are amortized by 3 years and 5 years respectively (the first year decoration cost is amortized by 3 years, and the fourth year decoration expenses are amortized by 5 years).
• (13) Payment receivable and employee compensation payable treatment.
• (14) It is estimated that the accounts receivable of the first year will be 10% of the operating income of the year, and the accounts receivable of the next 2-4 years will be 20% of the operating income of the year.
• (15) All expenses and employee compensation of the enterprise in the software development stage (the first two months) shall be paid in time, and there is no due payment. It is estimated that the accounts payable of the enterprise in the ten months after the first year will be 20% of the total advertising expenses and business entertainment expenses of the current year.
• (16) The annual receivables and payments payable shall be recovered and paid at the beginning of the next year.
• (17) 10% of the payable employee compensation payable shall be paid at the beginning of next year.
• (18) Employee salary is divided into four grades: 8,000 yuan, 6000 yuan, 4000 yuan and 3000 yuan, and 14% of the welfare fund, 2% of the employee education funds and 2% of the union funds.
• (19) The enterprise will conduct an impairment test on the intangible assets at the end of each year, and it is expected that the intangible assets will not be impaired within five years.
• (20) The applicable tax (fees) and tax (fees) rates of the company are listed as follows: Company business tax and additional tax (5%) Corporate income tax (25%).
• (21) According to the forecast of the companys operating conditions in the next few years, the company can maintain a high profit growth. It is planned to take a reasonable proportion of funds from the net profit as a return for shareholders. Meanwhile, in order to ensure the capital needs of the company when expanding business, the company will not pay dividends in the first year and the second year. In the third year, the proportion of 20% of the net profit and the proportion of 40% of the annual net profit after the third year.
• (22) The main business costs include the salary of the technical personnel of the server and the operating expenses of the website.
• (23) Fuel, water, electricity and alkali costs are calculated according to their annual consumption multiplied by the corresponding price, and consider certain losses. Among them, the price of fuel fuel is 1.8 yuan / kg, the water fee is 2 yuan / ton, the alkali is 250 yuan / ton, and the electricity fee is 0.8 yuan / degree.
• (24) Other manufacturing expenses shall be calculated at 20% of the direct wages.
• (25) Other management fees shall be 10% of the manufacturing cost excluding depreciation.

financial statements

forecast balance sheet

Forecast profit statement

cash flow statements

Analysis of financial indicators

profitability

In the enterprise financial evaluation system, profitability is the core, which is an important content to measure whether the enterprise has vitality and development future. The following paper analyzes the profitability and operating ability of the company from the three indicators of net interest rate of total assets, net interest rate of sales and net interest rate of equity:

debt paying ability

As can be seen from the above table, the proportion of current assets in total assets is 97.65%, and the proportion of non-current assets in total assets is 2.35%, indicating that the enterprise has strong flexibility, but the foundation is relatively weak, and there is no risk in the recent operation, but the long-term operation risk is large.

The proportion of current liabilities in the total liabilities is 45.19%, indicating that enterprises are strongly dependent on short-term funds, and enterprises are under great pressure to repay debt in the near future.

The liabilities of non-current assets were 54.81%, indicating that the enterprise is highly dependent on long-term funds in the process of operation. The long-term debt repayment pressure of enterprises is very great.

• (1) Short-term solvency index analysis

  Short-term solvency indicators

  a particular year	the first year	the next year	The third year	The fourth year	The fifth year
  working capital	473,533.20	595,547.40	793,936.17	967,533.09	1,194,471.11
  current ratio	4.54	5.77	5.81	4.36	4.38
  quick ratio	4.46	5.23	7.17	6.53	6.82
  cash ratio	0.46	0.23	0.17	0.53	0.82

  computational method:
  A. Working capital = current assets-current liabilities
  B. Current ratio = current assets / current liabilities
  C. Quick ratio = quick assets / current liabilities
  D. Cash ratio = (monetary funds + trading financial assets) / current liabilities

  • 1. Working capital analysis

    The more working capital, the more the solvency, the stronger the short-term solvency of the enterprise. The higher the chance of creditors recovering their claims. Therefore, the amount of working capital can reflect the ability to pay off the short-term debt.

    For the enterprise, the increase in net working capital indicates that the enterprise has strong short-term solvency, and the risk of short-term insolvency is low. Compared with the beginning of the year, the working capital has increased by 122,140.2 yuan, indicating that the working capital situation of the enterprise continues to rise, further reducing the risk of insolvency.

  • 2. Current ratio analysis

    The current ratio is a more commonly used ratio to evaluate the solvency of enterprises. It can measure the size of the short-term solvency of enterprises.

    For creditors, the higher the ratio, the better. A high ratio means that the ability to repay the short-term debt is strong, and the debt is guaranteed. For the owner, this ratio should not be too high. The high ratio indicates that a large amount of funds are overstocked in the form of current assets held, which affects the high-speed operation in the production and operation process and affects the efficiency of the use of funds. If the ratio is too low, it means that the ability to repay short-term debt is low, which affects the financing ability of enterprises, and is bound to affect the smooth development of production and operation activities.

    When the current ratio is greater than 2, it means that the solvency of the enterprise is strong. When the current ratio is less than 2, it means that the solvency of the enterprise is weak. When the current ratio is equal to 1, it means that the solvency of the enterprise is more dangerous. When the current ratio is less than 1, it means that the solvency of the enterprise is very difficult.

    Our company, the current ratio is 4.54, according to the general recognized standards, indicating that the solvency of the enterprise is strong, and the short-term solvency is further enhanced compared with the previous year.

  • 3. Quick ratio analysis

    Although the current ratio can be used to evaluate the overall liquidity of current assets, it is also hoped that, especially short-term creditors, will obtain a further ratio indicator of liquidity than the liquidity ratio. This is the quick ratio.

    The normal quick ratio is usually considered to be 1, and the quick ratio lower than 1 is considered that the enterprise faces a great debt repayment risk. The important factor affecting the credibility of the speed ratio is the liquidity of accounts receivable. The accounts receivable on the book may not always be cash, the actual bad debts may be more than the provision; so the evaluation quick ratio should be combined with the accounts receivable turnover rate. The quick ratio is the same as the current ratio, which reflects the final situation and does not represent the long-term debt situation of the enterprise.

    The quick ratio of the enterprise is 4.64. For the accepted standards, the short-term solvency of the enterprise is relatively strong.

    Further analysis of the reasons for our companys strong solvency can be seen that the proportion of the companys monetary capital in the total assets is relatively high, and the excessive occupation of the companys monetary capital will greatly increase the opportunity cost of the enterprise.

  • 4. Cash rate analysis

    The cash ratio is the balance of the quick assets after deducting accounts receivable. The amount calculated by the quick assets after deducting the accounts receivable can best reflect the ability of the enterprise to directly repay the current liabilities. The cash ratio is generally considered better at more than 20%. However, this ratio is too high, which means that the current assets of enterprises have not been used reasonably, and the profitability of cash assets is low. The high amount of such assets will lead to the increase of the opportunity cost of enterprises.

    As can be seen from the above table, the cash ratio is 0.46, which is much higher than the general standard of 20%, indicating that the enterprise has a good ability to directly repay the current liabilities, but the working capital has not been fully utilized.

• (2) Long-term solvency index analysis

  Long-term solvency indicators

  a particular year	the first year	the next year	The third year	The fourth year	The fifth year
  asset-liability ratio	0.84	0.69	0.09	0.38	0.30
  equity ratio	1.26	1.27	1.32	1.42	1.43

  computational method:
  A. Asset-liability ratio = total liabilities / total assets
  B. Title ratio = total liabilities / shareholders equity

  • 1. Asset-liability ratio

    The asset-liability ratio reflects the comprehensive ability of the enterprise to repay debts, and the higher the ratio is, the worse the ability to repay debts; on the contrary, the ability to repay debts is stronger.

    It is generally believed that the appropriate level of the asset-liability ratio is 0.4-0.6. For enterprises with relatively high operating risk, relatively low asset-liability ratio is selected to reduce financial risk; for enterprises with low operating risk, relatively high asset-liability ratio should be selected to increase shareholder income.

  • 2. Property ratio

    The ratio of property rights not only reflects the relative relationship between the capital provided by the debtor and the capital provided by the owner, but also reflects the ability of the enterprises own funds to repay all the debts. Therefore, it is an important indicator to measure the safety of the enterprises debt operation. Generally speaking, the lower the ratio indicates that the stronger the long-term solvency of the enterprise, the higher the protection degree of creditors rights and interests, and the smaller the risk borne. Generally, it is believed that this ratio is within 1, that is, below 1, which should be solvent, but it should also be analyzed according to the specific situation of the enterprise. When the return on assets of an enterprise is greater than the liability cost rate, the debt operation is conducive to improving the return on capital and obtaining additional profits, then the property right ratio can be appropriately higher, which is the financial structure of high risk and high remuneration; the low property right ratio is the financial structure with low risk and low remuneration.

operation capacity

Caltable of operating capacity indicators

• 1. Business cycle refers to how long it takes to convert all the ending inventory into cash. The short business cycle indicates that the capital turnover speed is fast and the normal flow ratio is low. We can see from Table 2-4 that the business cycle of GCSSC is short and the inventory liquidity is strong.

• 2. Inventory turnover rate is the ratio of the sales cost of goods to the average inventory in a certain period of time. It is an indicator to measure the realization speed of the companys inventory, the companys sales ability and whether the inventory is excessive. Generally, the higher the inventory turnover rate, the stronger the liquidity or liquidity of the companys inventory, the higher the sales or turnover, and the higher the profitability. The calculation formula is: inventory turnover rate = cost of sales / average inventory.

  As can be seen from the table, the inventory turnover rate of the company has been at a relatively stable level in the past three years, with a small range of change, and the inventory turnover speed is relatively fast.

• 3. The turnover rate of accounts receivable is an important indicator of an enterprise. Even the recovery of accounts receivable can not only enhance the short-term solvency of an enterprise, but also reflect the efficiency of the enterprise in managing accounts receivable.

  As can be seen from Table 2.4, the companys receivables recovery rate was the fastest in the second year, 8.8% faster than in 2008 and 25.26% faster than in the first year. This is mainly due to the companys strengthening of management and improving work efficiency, resulting in the increase of the main business income and the decrease of accounts receivable, and thus accelerating the recovery speed of accounts receivable.

• 4. The turnover rate of current assets refers to the number of turnover of current assets in a certain period of time and the number of days required for one turnover of goods. It is mainly an important index to measure the turnover rate of current assets, and can reflect the utilization efficiency of all current assets. The calculation formula is as follows: turnover rate of current assets = sales income / average balance of current assets.

  Accordingly, it is concluded that the companys current assets turnover rate for three years is 0.79,0.78 and 0.80, respectively. It can be seen that the companys current asset turnover rate is the fastest in the second year, but compared with the change is not obvious. It can be seen that the utilization efficiency of current assets is relatively high, and the annual change is stable.

• 5. Total asset turnover is the ratio of the companys sales revenue to the average total assets, which is mainly used to evaluate the operating efficiency of all assets. According to the definition, the total asset turnover rates in the third year, the second year and the first year are 0.65,0.66 and 0.64, respectively. According to the income statement, the sales revenue in the past three years is at a stable level, and the operating efficiency of assets is relatively good.

  Comprehensive analysis can be seen that the companys current operating situation is better, and showed a trend of improving year by year, the company should continue the rising momentum, improve the efficiency of using the economic resources, including the enterprise assets turnover speed and utilization efficiency of human resources, to make the enterprise more effective use of assets, make more profits.

Growth ability

Sales growth rate, total assets growth rate.

Growth ability index calculation table

The companys sales growth rate was 250% in the second year and 60% in the third year. The companys total assets growth rate was 23% in the second year and 38% in the third year. From these data, it can be seen that the enterprise is still developing, and the growth rate is fast.

Investment recovery analysis

Through the net cash flow, discount rate, the investment payback period is two years and three months, and the investment plan is feasible.
According to: Ik= Ok

Investment recovery forecast table

computational method:
A. Payback period = cumulative net present value positive years-1 + (unpaid cash / current year present value)
B. Investment payback period = 2+12515213.80/6296312.20=2.2 That is, the investment payback period is two years and three months, and the investment plan is feasible.

Net present value of investment

Net present value of the Project investment:

Considering the current low cost of capital, as well as the opportunity cost of capital in the same industry and the risk of investment and other factors, I takes 10% (the same below), at this time, NPV = 2012 (10,000 yuan), much greater than zero. The profitability during the calculation period is very good, and the investment plan is feasible.p>

Inclusion rate of remuneration

The embedded remuneration rate calculated in the cash flow statement is as follows:

The embedded return rate reaches 12%, which is greater than the capital cost rate of 10% and greater than the embedded return rate of 8% in the same industry, mainly because of the high quality and low price of the product, the sales profit margin is high. Moreover, the market growth in the first five years is very good.

overall merit

Through the investigation of the above evaluation indicators, the following conditions are also met:

• (1) Net present value NPV> 0
• (2) Inclusion of return rate IRR> 10% (capital cost rate)
• (3) The investment payback period is <3 years

It can be concluded that the investment project has financial feasibility in any aspect, and the investment project should be accepted.