Purpose and Our Product
Background

Today, the number of obese individuals worldwide has reached 1 billion, and the problem of increasing obesity rates is not limited to adults; many children and adolescents also face obesity. In 2022, it was reported that 880 million adults and 159 million children were obese globally, with the obesity rate among minors increasing fourfold and that among adults rising by more than double. In daily life, we frequently encounter people affected by obesity, whose weight-related limitations lead to various inconveniences. Beyond daily difficulties, obesity can cause hypertension, obstructive pulmonary disease, and a range of cardiovascular diseases. Moreover, many obese pregnant women face complications during childbirth, including a higher likelihood of miscarriage, stillbirth, and preeclampsia compared to healthy women. Thus, addressing the obesity issue to improve public health and quality of life is an urgent matter. These individuals often resort to unhealthy or even dangerous methods to achieve their desired body shape quickly. To assist those seeking to lose weight in a healthier and more effective manner, our team has conducted extensive research on the disease and collected data on public willingness to lose weight. We decided to utilize probiotics to help those struggling with obesity and others in need of weight loss achieve their goals more gently and effectively.##Product Description


Product

E.coli Probiotic Lyophilized Powder Capsules and Bottled E.coli Probiotic Lyophilized Powder


Form: Capsules and Bottled

The production of E. coli lyophilized powder capsules and bottled powder can utilize large-scale liquid fermentation, solid surface fermentation, and submerged fermentation techniques. The process involves fermenting genetically modified E. coli while controlling conditions—keeping the inoculated culture at a low temperature of 25°C to slow protein expression, allowing for proper folding and activity. The cultured E. coli is stored at 37°C to 39°C, its optimal growth temperature, before being extracted and frozen at -80°C for preservation. Throughout the process, conditions such as moisture, activity, oxygen levels, and temperature are meticulously controlled to ensure the strains maintain their integrity, activity, and stability. The genetically modified E. coli is then converted into lyophilized powder and stored in capsules or small bottles.


Product Formula

Ingredients: Edible glucose, Skim milk powder,E. coli probiotic lyophilized powder (28%) {E. coli (E. coli Nissle 1917)}, isomaltoligosaccharides, DHA algae oil, dietary fiber, taurine, vitamin A, vitamin B, vitamin C.

Product Efficacy

We have developed a probiotic that aids in weight loss. It secretes GLP-1, which slows gastric emptying, increasing feelings of fullness and helping to reduce body weight. Additionally, it secretes Bimagrumab, which effectively increases muscle mass. Finally, we have designed a self-destruction system to ensure the safety of the product.

Product Positioning

Our product is aimed at patients with obesity, specifically those with a BMI ≥ 30 kg/m² or a BMI ≥ 28 kg/m² with comorbidities, serving those who have a necessary need to lose weight. The product features a stable drug concentration curve and eliminates the need for injections, reducing difficulties and inconveniences during the weight loss process. The cost of producing the probiotic freeze-dried powder from E. coli is influenced by various factors, including raw material procurement costs, investments in production equipment and facilities, labor costs, quality control and testing costs, packaging costs, transportation costs, as well as the scale and production efficiency of the enterprise. Generally, small-scale production costs may range from a few yuan to several tens of yuan per unit. However, since we aim for large-scale industrial production, optimizing production processes and increasing raw material procurement can reduce costs to as low as a few dimes per unit or even lower. Throughout the production process, we will employ advanced technologies and management measures to ensure environmental sustainability. For example, we will optimize energy consumption in production, utilize clean energy, continually improve production processes, reduce unnecessary steps and resource waste, and enhance production efficiency. Our product is classified as a prescription drug, requiring a doctor's prescription for purchase in hospitals or pharmacies. Users must adhere to medical guidance regarding appropriate methods and dosages, avoiding unauthorized misuse to prevent adverse health effects.

Product Advantages

1.Helps patients achieve fat loss while providing convenience.

2.Prevents muscle loss during the fat reduction process.

3.Higher success rate without significant challenges, such as strict diets or exercise regimens.

4.Simple production process and low cost, resulting in an affordable price.

5.Does not require injections, alleviating fear associated with needles.

6.Allows for quick mitigation of side effects through self-destruction of engineered bacteria induced by arabinose.

Target Customers
Target Customer Analysis

Our product is designed for individuals with a BMI (Body Mass Index, a measure of body fat based on height and weight, applicable to adult males and females) greater than 30, which can be defined as overweight or obese.

Target user communication
Coaches from weight loss camps

We interviewed a weight loss camp coach. The coach emphasized that fitness is much more important than relying on weight loss pills. He pointed out that the key to weight loss lies in the balance between calorie intake and expenditure. Although there are many weight loss products on the market, such as meal replacements, diet pills, and weight loss teas, these often work by reducing appetite or increasing elimination, which are not sustainable methods and may cause side effects. In contrast, exercise, especially aerobic exercise, is an effective means of promoting fat breakdown. However, for individuals with a higher weight baseline, exercising may not be suitable, as it could impose additional burdens on their bodies. In such cases, they may need to use weight loss medications to assist in achieving safer and more effective weight loss goals.

After our lab work concluded, we contacted the coach of the weight loss camp by phone to update him on the progress of our project. He was very pleased and expressed excitement about our advancements in the weight loss field. Furthermore, he mentioned that if our product successfully reaches the market, he would be happy to recommend it to individuals in need, as part of his role as a coach, helping them achieve their weight loss goals.


Team Members' Self-Experiments

Our team includes several members with a higher weight baseline, so we tried exercising together. After a period of workouts, although there was some weight change, one member experienced noticeable knee pain. The coach explained that this pain was mainly due to the extra pressure on the knees caused by the higher weight during exercise. To protect the knees, the coach advised us to pause high-intensity workouts and focus on dietary adjustments to lose weight, gradually resuming exercise once physical condition improved. This made us realize that weight loss isn't solely reliant on exercise; individuals with higher weight baselines need supplementary methods to assist in their weight loss efforts.


Weight Loss for Children (with consent from minors and their guardians)

We interviewed a child who needed to lose weight. He admitted that he really enjoyed eating fried chicken and burgers, which contributed to his high weight. Although he recognized the need to control his diet, he found it very difficult in practice. During his weight loss journey, he discovered that low-fat, low-oil, and low-salt foods often lacked appeal and didn’t taste as good as the fast food he liked. Additionally, the hunger caused by dietary restrictions made it even more challenging for him to stick to his plan. He yearned to find healthy food options that could satisfy his cravings while also helping him lose weight.

Successful Weight Loss Individuals

We interviewed a person who successfully lost weight, and he shared his weight loss journey. He believes that success in weight loss relies 50% on exercise and 50% on strict self-management. During his weight loss period, he often felt hungry but couldn’t indulge in food, especially before bed when he would find himself repeatedly opening the fridge, facing the temptation of food. Due to a busy work schedule, he couldn't consistently exercise, and eating too little sometimes caused discomfort in his heart. This challenging process made him realize that controlling weight requires not only willpower but also a healthy approach.

Weight loss is not just a challenge that requires determination; it also needs to be personalized according to each individual's specific situation. For overweight office workers who have busy schedules, traditional exercise may not be suitable for weight loss, and they often struggle to make effective dietary adjustments on their own. In such cases, a healthy method is needed to help them manage cravings for food, maintaining balance during their weight loss journey.

Medication Users

Liu is currently using GLP-1 and shared his experience with us. He mentioned that the effects are significant, but the injection method is uncomfortable. Additionally, the concentration of the medication can cause periodic physical discomfort, increasing the challenges of usage. These issues require patients to carefully weigh the pros and cons during use.

For those needing to lose weight, the goal is not just to improve appearance but also to enhance health. Many people recognize that obesity can lead to high blood pressure, diabetes, heart disease, and other health problems, but they often face difficulties in controlling their diet and maintaining an exercise routine during the weight loss process. Especially in a busy lifestyle, they need to find methods that are effective for weight loss but not overly painful.

Weight Loss Demand Population

We spoke with a weight loss blogger who is currently managing her diet by restricting her food intake daily. However, she finds it very challenging to resist the temptation of delicious foods and sometimes indulges in binge eating. We introduced her to GLP-1 and mentioned its effectiveness. She expressed willingness to try it but feels some fear about the injection method and would prefer an oral supplement or medication instead. For individuals with weaker self-control, current weight loss methods can indeed be very challenging. For most, self-control is a significant hurdle, and each failure can add a heavy psychological burden. Those with lower psychological resilience often fall into deep anxiety. Therefore, finding a gentler and more effective weight loss method is crucial to help alleviate their mental burden while achieving their weight loss goals.

Weight Loss Bloggers

We also interviewed a weight loss blogger on Douyin who has 359,000 followers. She admitted that, due to her high weight, she cannot rely on exercise to lose weight as it adds extra strain to her body. During our conversation, we introduced her to GLP-1, and she expressed strong interest, especially if it could be taken orally. This feedback encouraged us to develop our product in an oral capsule form.

Athletes and coaches

We first interviewed a team member who mentioned that weight management is not only a concern for overweight individuals, but athletes also require strict weight control. To explore whether our product could benefit athletes, we conducted interviews with several students from a sports school.

We spoke with athletes in fencing, trampoline, gymnastics, and martial arts. They expressed the need for precise dietary control and exercise plans, as relying solely on reducing food intake could lead to muscle loss, which is detrimental for athletes. They hoped we could develop a muscle-building drug component that must not be on the doping list.

Additionally, we interviewed their coaches, who pointed out that using drugs to control weight and increase muscle mass not only violates sportsmanship but may also contravene legal regulations. They emphasized that even if a drug is not currently classified as a performance enhancer, it could be added to the list in the future. Moreover, they noted that for obese individuals, using GLP-1 could lead to a decrease in basal metabolic rate, which is not favorable for weight loss. Therefore, it is crucial to ensure that muscle is preserved for those needing to lose fat.

Endocrinologist

The doctor mentioned that this is a very promising direction, but it is essential to be cautious about avoiding drug misuse, especially among individuals who are not overweight or obese using the medication for further weight loss, which could pose risks. She suggested that we limit our target population to those with a BMI greater than 30 or a BMI greater than 28 accompanied by obesity-related underlying conditions. This definition of the target group can ensure safer and more effective use of the medication, reducing unnecessary health risks. Additionally, such positioning will help us clearly define our target audience in market promotion, enhancing the product's relevance and effectiveness.


Product Development Plan
Market Analysis
Market Size

The market of obesity is huge in the whole world. Our product aims to overcome shortages on Semaglutide, the main loss weight pills nowadays, such as inconvenience and expensive, and provide those individuals who cannot neither use Semaglutide nor persist to taking exercise through long-time periods.

In our region, China, since the large amount of basic population around the world, becomes the country with the greatest number obese groups in 2020. About 5% residents of the total population are suffering the obesity, including 43.2 million men and 46.4 million women, and 20% of patients lives in metropolis (See Fig.1.1).[1] What is worse, though the decreasing rate in obese groups occurs contrast 2023 and 2024, the percentage of people with obesity continues to increase (See Fig.1.2). [2]What’ more, obesity patients gradually younger.

Semaglutide is the most popular obesity treatment in recent market. Shown on Fig 1.3, Novo Nordisk created 610 million USD by Semaglutide in one quarter year in 2024 which is even valuable than the GDP of Denmark in 2023. In anticipation, the revenue provided by Semaglutide will increase in an increasing rate. These evidence reveals the obesity market is huge enough and our program owns the potential to extend.A protein called GLP-1 contained in Semaglutide is the main factor in meeting people's needs, so we decided to produce a new product.

Competitive Analysis
#Competitor
##Semaglutide

Retail Price: $950.52[4]

Semaglutide should be injected once a week at any time of day, without needing to coordinate with meal times. It is administered via subcutaneous injection, with injection sites including the abdomen, thigh, or upper arm. Changing the injection site does not require dose adjustments. This medication should not be injected intravenously or intramuscularly. If necessary, the weekly administration date can be adjusted, provided that doses are spaced at least 2 days (more than 48 hours) apart. Once a new administration time is chosen, weekly injections should continue.

The starting dose of semaglutide is 0.25 mg once weekly. After 4 weeks, the dose should be increased to 0.5 mg once weekly. Following at least 4 weeks at the 0.5 mg dose, it can be escalated to 1 mg once weekly to further improve blood sugar control. The 0.25 mg dose is not intended for maintenance, and it is not recommended to exceed a weekly dose of 1 mg.

When semaglutide is used in conjunction with existing metformin therapy, the current metformin dosage should remain unchanged. If it is used alongside sulfonylureas, consideration should be given to reducing the sulfonylurea dosage to minimize the risk of hypoglycemia. Self-monitoring of blood glucose is not required for adjusting the semaglutide dose; however, when starting treatment with semaglutide and sulfonylureas together, self-monitoring of blood glucose may be necessary to adjust the sulfonylurea dosage and reduce the risk of hypoglycemia.

##Liraglutide

Retail Price: ¥780/9ml

Liraglutide should be injected once daily at any time, without needing to align with meal times, although it is recommended to inject it at the same time each day. The injection is administered subcutaneously, with possible sites including the abdomen, thigh, or upper arm. Changing the injection site or time does not require dose adjustments.

For special populations, patients with liver or kidney impairment generally do not need dosage adjustments. This includes those with mild, moderate, or severe kidney impairment, as well as patients with mild or moderate liver impairment. Patients who are also taking insulin or insulin secretagogues may need to reduce those doses to lower the risk of hypoglycemia, following medical guidance.

For off-label use, the initial dose for patients with a BMI over 27 kg/m² or over 30 kg/m² is 0.6 mg daily, which should be increased to 1.2 mg after at least one week. The dosage can be adjusted weekly based on clinical response, with a gradual increase to 1.8 mg, 2.4 mg, or 3.0 mg as needed, according to medical advice.

To improve gastrointestinal tolerance, the starting dose is 0.6 mg daily, increasing to 1.2 mg after at least one week. For further improvements in glycemic control, the dose may be raised to 1.8 mg after a minimum of one week, with a maximum recommended daily dose of 1.8 mg, as advised by a healthcare professional.

##Yue Shen Heat Burn Tablets

Price: ¥328/month

Dosage: Take three tablets once a day after meals with warm water.

#Competitor Analysis:
##Semaglutide

Advantages: (1) Results can be seen in 1-3 months. (2) Can lower blood sugar and treat diabetes.

Disadvantages: (1) Only available via injection, which many people find psychologically unacceptable. (2) Not environmentally friendly; injection needles and equipment are single-use. (3) May suppress appetite, leading to malnutrition. (4) Possible side effects include hypoglycemia and digestive issues. (5) High price, making it unaffordable for the average person.

##Yue Shen Heat Burn Tablets

Advantages: (1) High cost-performance ratio. (2) Simple administration method. (3) Relatively environmentally friendly.

Disadvantages: (1) Results may not be significant. (2) Possible side effects include gastrointestinal discomfort and nausea.

#Self-Analysis

Compared to traditional weight loss methods like appetite suppressants or sleeve gastrectomy, probiotics offer a gentler, non-invasive approach that may be less effective for urgent weight loss needs. Some weight loss products might not be suitable for individuals with specific health issues (e.g., diabetes, heart disease, thyroid problems), potentially worsening their conditions. Additionally, certain products can lead to nutritional imbalances, failing to provide comprehensive nutrition. Effective weight loss often requires exercise, which these products cannot replace.

##Advantages of Our Product

Currently, the most popular GLP-1 products are administered via injection, whereas our solution is a convenient oral probiotic powder. While some weight loss methods come in oral form, they often present various drawbacks. Our probiotic powder offers a unique alternative, providing a user-friendly method without the intimidation of injections. Additionally, probiotics contribute to overall health benefits, such as immune support and mood enhancement through the gut-brain axis, while also offering fewer side effects compared to traditional weight loss options, making it more suitable for long-term use.#####Disadvantages of Our Product

Every product has its drawbacks. While weight loss probiotics can aid in lowering blood sugar and reducing fat, they also have certain limitations. The primary function of our product is to improve gut microbiota absorption through probiotics. However, gut microbiota varies from person to person, which means the effects of the product will differ. Some users may experience significant results, while others might see little to no change. Additionally, some individuals may experience digestive discomfort such as bloating or diarrhea when they first start using probiotics.

SWOT Analysis
Cost Analysis

We conducted a detailed analysis of our costs by researching relevant materials and examining market trends and competitors' pricing strategies. This helped us identify various cost components, including raw materials, production, marketing, and operational costs.

Labor Costs

Note!!!: Since we plan to conduct our research and development primarily in China, all of the following currencies are in RMB.

Sales: ¥9,542 per person/month

Total: ¥9,542 × 10 people × 12 months = ¥1,145,040

Management: ¥12,513 per person/month [6]

Total: ¥12,513 × 4 people × 12 months = ¥600,624

R&D: ¥21,364 per person/month [7]

Total: ¥21,364 × 12 people × 12 months = ¥3,076,416

Our team consists of 26 members: 10 in sales, 4 in management, and 12 in R&D.

Total Annual Labor Costs: ¥4,822,080.

Venue Costs

Venue Fee: ¥20 per square meter per month

Estimated Rental Area: 17,000 square meters

Total Annual Rent: ¥20 × 17,000 × 12 = ¥4,080,000

Total Annual Venue Costs: ¥4,080,000.

Equipment Costs
#Active Pharmaceutical Ingredient Production Equipment

Stainless Steel Fermentation Tank: ¥10,000 each [9]

Stirring Equipment: ¥1,000 each [10]

pH Meter: ¥18,800 each [11]

Dissolved Oxygen Meter: ¥45,000 each [12]

Fermentation Bed: ¥18,900 each [13]

Reaction Kettle: ¥42,800 each [14]

Total Cost: ¥91,500

#Formulation Production and Packaging Equipment

Extraction Tank: ¥4,800 each [15]

Centrifuge: ¥12,000 each [16]

Vacuum Freeze Dryer: ¥185,000 each [17]

Crushing Equipment: ¥10,000 each [18]

Capsule Filling Machine: ¥53,000 each [19]

Automatic Canning Machine: ¥66,700 each [20]

Capper: ¥12,000 each [21]

Total Cost: ¥158,500

Total Equipment Costs: ¥250,000.

Preliminary R&D Costs

The estimated R&D costs total around ¥200 million. This includes approximately ¥100,000 to ¥200,000 for purchasing 1,000 laboratory mice, and about ¥500,000 for acquiring 10 laboratory pigs or monkeys. Phase I clinical trials are projected to cost around ¥8 million, covering expenses such as personnel (salaries and benefits for researchers, clinical doctors, and subject management staff), drug supply (production, procurement, storage, and distribution), subject recruitment and management (advertising, screening, surveys, and compensation), and data collection and analysis (data management system construction, data entry and cleaning, and statistical analysis).

Phase II clinical trials are estimated at around ¥49 million, with increased costs due to larger personnel needs, greater drug supply requirements, and the need to recruit and manage more subjects. Additionally, costs associated with the trial site and data collection will also rise.

Phase III trials are expected to cost approximately ¥80 million, primarily due to significantly higher personnel costs, increased drug supply needs, and substantial expenses related to subject recruitment and data analysis necessary for drug registration.

Finally, Phase IV clinical trials will likely incur around ¥60 million, primarily covering subject recruitment and management, drug supply, data collection and analysis, safety monitoring, and other operational expenses.

Raw Materials

Glucose: ¥4,500/ton [22]

Milk powder: ¥360/kg (Total: ¥360,000/ton) [23]

Agar culture plates: ¥240/box [24]

Isomalto-oligosaccharides: ¥6,000/ton [25]

DHA algae oil: ¥320/kg (Total: ¥320,000/ton) [26]

Dietary fiber: ¥60/kg (Total: ¥60,000/ton) [27]

Taurine: ¥18/kg (Total: ¥18,000/ton) [28]

Vitamin A: ¥210/kg (Total: ¥210,000/ton) [29]

Vitamin B: ¥150/kg (Total: ¥150,000/ton) [30]

Vitamin C: ¥18/kg (Total: ¥18,000/ton) [31]

Total Cost: ¥1,146,740

Financial Plan

For our project, we aim to raise 10 million yuan in the initial phase, which will be allocated to research and development, production equipment, marketing, and the first six months of operating costs. Based on market research, we have priced our product at 210 yuan per bottle, with a target of selling 100,000 bottles in the first year, generating an expected revenue of 21 million yuan. We anticipate a 50% increase in sales in the second year and a 30% increase in the third year. This sales growth forecast will provide a sustainable foundation for our project and offer good returns for investors.

Development Plan
Initial Market Demand Analysis

Our goal is to help individuals with weight loss needs achieve healthier and more effective results. Through extensive research on obesity, public weight loss motivations, and health trends, we have decided to use probiotics to assist those struggling with obesity and weight management to achieve a more efficient, gentle, and effective weight loss solution.

To develop this probiotic weight loss product, we first studied the current state of the weight loss market, which includes mainstream weight loss products like meal replacements, nutritional supplements, functional slimming foods, and medications (e.g., GLP-1 receptor agonists), as well as surgical interventions. We also interviewed leading brands in the market, such as Herbalife, Orlistat, and Semaglutide injections, analyzing their market share and competitiveness.

Next, we focused on understanding consumer demand by analyzing our target audience, which includes young women, middle-aged individuals, and people with obesity. We evaluated their weight loss needs and preferences, finding that safety, effectiveness, convenience, and personalized solutions were their main concerns. We also examined the consumer decision-making process, including how they gather information, select products, and make purchasing decisions.

Competitive Landscape and Market Trends

We analyzed the competitive landscape by reviewing the major players in both domestic and international markets. We segmented the market based on product type, consumer demographics, and sales channels, and predicted future trends in the weight loss market, such as the rise of healthier weight loss methods and the growing popularity of personalized weight loss plans.

In our initial short-term market research (1-2 weeks), we gathered a general understanding of the market through industry reports, market analysis articles, and news sources. This provided us with a broad overview but lacked detailed data. Therefore, we conducted a more in-depth medium-term market study (1-2 months), focusing on detailed product analysis, consumer demand segmentation, and a clear description of the competitive landscape. This phase involved gathering and analyzing data, conducting surveys, and interviewing industry experts to obtain more comprehensive insights.

Recognizing that the weight loss market is constantly evolving, with new products, technologies, and trends emerging, we have maintained ongoing market tracking and research. This allows us to stay attuned to market dynamics and adjust our strategy accordingly as we develop our probiotic weight loss product.

Scientific Principle and Mechanism Research

After clarifying market demand, we began studying the scientific principles behind probiotics and their weight loss potential. We investigated how probiotics regulate gut microbiota, improve metabolic functions, and enhance satiety, providing theoretical support for our product development. Additionally, we researched the specific mechanisms through which probiotics affect fat metabolism, reduce energy absorption, and regulate hormone pathways to achieve weight loss. This has been crucial in optimizing our product formula and improving its effectiveness.

Risk Assessment
Long-Term Positive Impacts

1.Large Market Size, Few Competitors, and Broad Target Audience: Market research reveals that the weight loss drug market is vast and covers a wide range of target demographics. This includes not only individuals seeking to lose weight for aesthetic purposes but also those who need to reduce weight due to health conditions. GLP-1 holds a unique advantage in the market with relatively few competitors, showcasing significant market potential. By designing detailed surveys, the company can better understand consumer needs and preferences, enabling the development of more effective marketing strategies to ensure the product meets market demand optimally.

2.Widespread Promotion to Reduce Concerns about New Weight Loss Methods: The long-term development of GLP-1 involves not only the improvement and optimization of the drug itself but also continuous market promotion and publicity efforts. Through a series of educational and promotional activities, consumers can gradually understand and accept this new weight loss method, reducing concerns about its safety and efficacy. For example, clinical trial data, user testimonials, and expert endorsements can enhance public trust in GLP-1, encouraging more people to try and benefit from this weight loss approach.

3.Higher Cost-Effectiveness and Less Discomfort Compared to Other Weight Loss Methods: Traditional weight loss methods, such as dieting, intense exercise, and surgery, often require significant time, effort, and financial investment from users. As a pharmaceutical solution, GLP-1 offers substantial weight loss results through a simple administration method, reducing the economic and time costs for users, as well as the discomfort and hardship associated with the weight loss process. Its high cost-effectiveness and convenience make it an appealing option for more individuals seeking to achieve their weight loss goals.

4.More Noticeable Long-Term Effects and Easier to Maintain: The long-term use of GLP-1 can produce stable and significant weight loss results over time. Compared to short-term weight loss methods, this approach makes it easier for users to maintain their results. The sustained effect and gradual weight reduction instill greater confidence in users to persist in their efforts, leading to more enduring weight loss outcomes. This not only helps users maintain a healthy weight but also improves their overall health and quality of life. Positive user feedback and continued usage provide strong support for the further promotion and market acceptance of the drug.

Long-Term Negative Impacts

1.Harm to Non-Diabetic Users: According to interviews conducted at the Provincial Second Hospital, GLP-1 is primarily used to treat Type 2 diabetes by promoting insulin secretion and lowering blood sugar levels. In non-diabetic patients, using this drug may disrupt normal metabolic functions and lead to side effects like hypoglycemia. Therefore, doctors typically do not recommend GLP-1 for weight loss or other non-diabetic purposes. Misuse by non-diabetic individuals could result in metabolic disturbances that pose health risks.

2.Increasing Drug Regulation: As the misuse of GLP-1 by non-diabetic patients grows, legal and regulatory bodies are likely to impose stricter controls on the drug. This could include reclassifying the medication as a prescription-only drug and imposing stricter purchase and usage conditions to prevent misuse. These regulations aim to safeguard public health by mitigating the risks associated with drug misuse and ensuring that GLP-1 is used appropriately.

3.Dependency in Long-Term Users: Long-term use of GLP-1 might result in dependency, causing users to reduce or avoid regular physical activity. Since the drug effectively suppresses appetite and controls weight, some individuals may become overly reliant on it and neglect the importance of exercise and a healthy diet in maintaining weight and overall well-being. A lack of physical activity could lead to muscle loss, and increase the risk of cardiovascular diseases, osteoporosis, and other health problems.

4.Not Suitable for All Groups: Several groups should particularly avoid using GLP-1. Pregnant Women: The effects of GLP-1 on fetal development are not fully understood, so it is recommended that pregnant women avoid using this drug. Type 1 Diabetic Patients: GLP-1 is not designed to treat Type 1 diabetes, which requires a different form of treatment. Patients with Diabetic Ketoacidosis: The use of GLP-1 may exacerbate this condition, so it is best avoided by those at risk.

To address these negative impacts, we will develop a comprehensive usage guide to help users understand the risks and precautions associated with GLP-1. In the future, we also plan to raise awareness about healthy weight loss through lectures, online consultations, and distributing educational materials. These efforts aim to empower users to make informed choices, ensuring their health and safety while enhancing our product’s social responsibility.

Project Planning

Throughout the process of our project, we have explored several commercialization opportunities to identify the best market entry points and development paths.

21st Endocrinology Academic Conference—2024 Novo Nordisk Special Session

We attended the Endocrinology Academic Conference hosted by Novo Nordisk, the leading manufacturer of GLP-1 products and a pioneer in insulin production. The conference focused on the clinical value and future applications of GLP-1 in diabetes treatment, with special attention on the innovation of oral GLP-1 formulations. This experience deepened our understanding of the therapeutic benefits and immense market potential of GLP-1, further boosting our confidence in developing our own probiotic-based weight loss solutions as a non-injection alternative to current GLP-1 products.


RenShen drugstore

We inquired at pharmacies about the current weight loss drugs on the market and their effectiveness. We learned that Orlistat is a common weight loss medication. While it effectively reduces fat absorption, it can cause an uncomfortable side effect of "oily leakage," which many users find troubling. Another past option was Sibutramine, which was popular due to its significant effects but has since been banned due to its severe side effects. This information gave us deeper insights into the range of weight loss medications available in the market, prompting us to consider how we can offer a safer, more effective alternative to meet consumer needs.


AIA Insurance Company

AIA Insurance Company has expressed interest in providing coverage for our product once it enters the market, assuming it is proven to be an effective weight loss drug. They noted that obesity leads to a range of underlying diseases, and they are willing to offer reimbursement for such a product. This support not only enhances the market competitiveness of our product but also signifies the insurance company's recognition of the role weight loss drugs can play in improving public health. By collaborating with insurance companies, we can further increase consumer acceptance and reduce their financial burden, thus attracting a larger population in need of weight reduction to consider and use our product. This partnership will not only help us achieve greater success in the market but also contribute to promoting public health.


Microbial Fermentation Plant

We attended a lecture organized by a microbial fermentation plant, where we gained in-depth knowledge about the specific processes of microbial fermentation in industrial settings. The experts provided detailed explanations of every stage, from strain selection and cultivation to the control of fermentation conditions, giving us a comprehensive understanding of the technical workflow in industrial fermentation. Additionally, we discussed the market prices and cost structures of industrial fermentation microbes, which provided valuable economic data and market insights for our subsequent project planning.


Interview with Dr. Dingyu Liu from Asymchem's Insulin Synthesis Department

We conducted an online interview with Dr. Dingyu Liu from Asymchem to learn more about the current production methods and market scale of GLP-1-related drugs. Dr. Liu explained that GLP-1 is mainly produced through heterologous expression in yeast, followed by side-chain modifications to extend the half-life of the purified peptides. However, this process is costly and yields relatively low. Regarding the weight loss drug market, Dr. Liu mentioned that as of 2023, GLP-1 holds a market share comparable to other synthetic biology products, indicating a promising market potential. After introducing our concept of weight loss probiotics, Dr. Liu expressed great approval of the project and provided valuable feedback and suggestions.


Guangzhou Biomedical Industry-Academia-Research Exchange Conference

We participated in the second Guangzhou Biomedical Industry-Academia-Research Exchange Conference, where we engaged in in-depth discussions with professionals in the field. They provided detailed explanations of the approval process for medical products, including clinical trials, registration applications, and various regulatory steps, which helped us gain a clearer understanding of the complexities involved in market entry. Additionally, Manager Zhou from Guangzhou Pharmaceutical Research Institute Co., Ltd. shared insights on financing, highlighting that sufficient funding is essential for the smooth development of our project. This information provided valuable guidance for planning the next steps in our project's development and financing strategies, while also deepening our understanding of future challenges.


Guangzhou Overseas Intellectual Property Talent Training Program

We attended the overseas intellectual property training in Guangzhou, where we learned about various aspects of intellectual property, including the patent application process, trademark registration, copyright protection, and their importance in business. Experts emphasized the critical role of protecting intellectual property in enhancing innovation and market competitiveness. We recognized that establishing a robust intellectual property management system is key to ensuring project success. Therefore, we need to actively develop an intellectual property strategy and apply for relevant patents and trademarks promptly to safeguard our innovations and prevent potential infringement risks. This will provide a solid legal foundation for the long-term development of our project.


Future Outlook

Looking ahead, in addition to optimizing the project, I aim to enhance my own skills. To further promote product development, we plan to expand our team and attract more professionals. This will strengthen our capabilities in technology R&D, market promotion, and customer service, ensuring that our products can better meet market demands and maintain a competitive edge. Furthermore, through team diversity, we can bring together different perspectives and experiences, fostering innovation and efficient collaboration, ultimately achieving greater success.


References

[1]Chen K, Shen Z, Gu W, Lyu Z, Qi X, Mu Y, Ning Y; Meinian Investigator Group. Prevalence of obesity and associated complications in China: A cross-sectional, real-world study in 15.8 million adults. Diabetes Obes Metab. 2023 Aug 17.

[2]chinanews.com.,2024.

[3]Company Announcement in Novo Nordisk official website, 22 May,2023.

[4]goodrx.com

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