Obesity is a global health crisis, affecting over ten billion people worldwide and causing metabolic disorders like diabetes and cardiovascular disease. Current solutions like diet, exercise, and GLP-1 drugs often have disadvantages like high cost, side effects, or poor long-term adherence. FatBuster pioneers a synthetic biology approach to address obesity after rigorous examination: gut microbiome-mediated metabolic dysfunction. By engineering E. coli to produce sulfide quinone oxidoreductase (SQR) and flavocytochrome sulfide dehydrogenase (FCSD), we target hydrogen sulfide (H₂S), a gut microbial metabolite that suppresses the GLP-1 signaling pathway, a key regulator of appetite and glucose metabolism. Our live biotherapeutic product aims to restore GLP-1 function, offering a simultaneous action of glucose control and fat reduction with minimal adverse effects.

Current treatments for obesity face several key challenges. First, existing medications have limited efficacy. GLP-1 agonists (e.g., semaglutide) require injections and often cause nausea and diarrhea, while oral drugs like Orlistat yield modest weight loss (5–10%) with gastrointestinal side effects. Second, gut microbiome dysbiosis in obesity is characterized by elevated hydrogen sulfide (H₂S) levels, which suppress GLP-1 secretion (reducing satiety signals) and promote fat storage through mitochondrial dysfunction, yet no therapies currently target H₂S for pharmaceutical intervention. Lastly, patient compliance remains a barrier, as injectable treatments are less preferred than oral alternatives, further limiting their real-world effectiveness. Fixing these gaps could improve obesity management.

Why

Obesity requires solutions that are not only effective but also safe, affordable, and sustainable in the long run. Current treatments often fall short due to side effects, cost, or limited patient adherence. FatBuster is built on a groundbreaking idea: targeting hydrogen sulfide (H₂S)—a key microbial metabolite in the gut that drives metabolic dysfunction. By focusing on this root cause, we aim to restore the body’s natural ability to regulate weight and glucose, offering a novel approach to microbiome-based metabolic repair.

How

FatBuster works through an orally administered capsule containing engineered E. coli, which continuously produces SQR and FCSD enzymes to break down excess hydrogen sulfide (H₂S) directly in the gut. By lowering H₂S levels, our treatment helps reactivate the suppressed GLP-1 signaling pathway, thereby enhancing the body’s natural appetite control and glucose metabolism. This process not only aids in blood sugar management but also promotes fat breakdown through restored mitochondrial function, delivering dual metabolic benefits in a single, patient-friendly oral format that supports long-term compliance.

What

FatBuster is a first-in-class oral live biotherapeutic product (LBP) designed to tackle the root cause of metabolic dysfunction, rather than merely addressing symptoms. It provides a non-invasive, convenient alternative to injectable drugs, and can work alongside existing therapies such as GLP-1 agonists, potentially enhancing their efficacy and tolerability. Ultimately, FatBuster represents a sustainable, physiology-driven strategy for long-term weight and metabolic health management.

The global GLP-1 receptor agonist market size was estimated at USD 53.46 billion in 2024 and is projected to reach USD 156.71 billion by 2030, growing at a CAGR of 17.46% from 2025 to 2030. This indicates that demand for this kind of drugs is increasing dinamicly, which brings us a prospective market outlook.

Figure 1 PEST Model

Political

China launches 3-year campaign on public year weight management since 2024. On June 30, China’s National Healthcare Security Administration (NHSA) and National Health Commission jointly released a sweeping new policy titled Several Measures to support the High-Quality Development of Innovative Drugs. The policy outlines 16 action items across five focus areas—spanning R&D, market access, clinical application, and reimbursement. Its aim is to streamline upstream and downstream drug development and better meet China’s growing medical needs. These political supports make the public realize the importance of weight management and provide a optimistic atmosphere for us to promote our project. China also subsidize Class 1 innovative drug developers with 20% of preclinical costs and state price stability protection for 1 to 5 years post-approval with more efficient centralized drug procurement listing.

Economic

China’s GDP reached RMB 134.91 trillion and a 5% growth, driven by stimulus measures, strong exports, and high-tech investment.

In 2024, the nationwide per capita disposable income was 41,314 yuan, a real increase of 5.1 percent after deducting price factor. The nationwide per capita expenditure was 28,227 yuan, a real increase of 5.1%. The real increase in GDP and per capital expenditure demonstrates positive economic environment where people are more likely to consume our drugs.

Social

According to the World Obesity Federation’s 2025 Atlas, the global population of adults with obesity is projected to surge by over 115% between 2010 and 2030, reaching 1.13 billion. The issue is particularly pronounced in China, where over half of all adults and roughly 20% of school-aged children are overweight. This pervasive trend is driving a growing demand for weight-loss solutions, indicating a substantial and expanding potential market for our product.

Technological

Novo Nordisk launched the combination formulation CagriSema (GLP-1&pancreatic amylin) with patent protection extended beyond 2040 to build new barriers. It is a barrier and challenge for our team to commercialize in the future.

Companies shifted from generic to differentiated innovation: e.g., development of oral dosage forms (Hengrui Pharma HRS-7535), multi-targeted drugs (Xindan Biomasdutide), triple-targeted agonists (Federal Pharma UBT251).

The competitive landscape is intensifying, as evidenced by Novo Nordisk's development of CagriSema. With patent protection extending beyond 2040, this combo-drug sets a high barrier for new entrants, posing a significant long-term challenge to our commercialization. Concurrently, a clear industry-wide shift from generics to differentiated innovation is underway, exemplified by novel oral formulations (e.g., Hengrui’s HRS-7535), multi-targeted drugs (Xindan’s Biomasdutide), and triple-agonists (Federal Pharma’s UBT251).

Figure 2 Porter’s Five Forces

Bargaining Power of Suppliers (low)

The fermentation process using E. coli is well-established and widely mastered by multiple suppliers. As a result, switching costs are low, and no single supplier can exert significant pricing power based on technical exclusivity. This limits the risk of technical premiums and keeps supplier bargaining power low.

Bargaining Power of Buyers (low)

Patients with severe obesity or those seeking urgent weight loss solutions tend to exhibit low price sensitivity, especially among individuals who have experienced strong side effects from existing treatments and are seeking a milder alternative. This strengthens the product's pricing leverage and leads to low buyer bargaining power.

Threat of New Entrants (low)

High R&D costs, extended development timelines, and stringent intellectual property protections collectively create substantial barriers to entry. As a result, the threat posed by new market entrants remains low.

Threat of Substitutes (high)

Semaglutide, a leading GLP-1 receptor agonist, already captures roughly 50% of the market. Its widespread adoption and proven efficacy make it a preferred choice for many patients, presenting a high substitute threat to new entrants in the weight loss drug segment.

Rivalry Among Existing Competitors (high)

A large number of domestic and international companies are developing GLP-1-based weight loss therapies, leading to intensified homogeneous competition. With over 60 candidates in advanced clinical stages, the market faces potential price competition and rivalrous pressure, resulting in a high level of existing competition.

Figure 3 SWOT Model

Strengths

Our product exerts its effects by modulating the gastrointestinal microenvironment to enhance the secretion of endogenous GLP-1. Although GLP-1 has a short half-life, the sustained elevation in its concentration prolongs the therapeutic effect, aligning with the body’s natural physiological processes and thereby improving safety. Moreover, we utilize a well-established E. coli fermentation process, which offers significant cost advantages compared to peptide synthesis routes.

Weaknesses

As an oral formulation, the drug’s absorption may be impaired by the body’s natural defense mechanisms in the gastrointestinal tract. Compared to injectable formulations, this may result in reduced bioavailability, which could partially compromise efficacy.

Opportunities

Beyond weight management, our drug may improve mitochondrial function and reduce systemic inflammation, offering potential additional health benefits. Furthermore, the strong emphasis on weight management in China, supported by government policies, presents a favorable environment for the development and adoption of our product.

Threats

Metabolites and by-products generated during the purification process may affect the quality of the target product, necessitating strict control measures. Additionally, scaling up production introduces variability in fermentation conditions, including temperature and pH control, which could challenge product consistency and process stability.

Figure 4 Comparing Metrics

Administration Route

Unlike most competitors—including Semaglutide, Liraglutide, Beinaglutide and Tirzepatide, which require subcutaneous injection—our drug is administered orally. This offers significant user convenience, improves adherence, and reduces discomfort associated with frequent injections.

Dosing Frequency

While injectable GLP-1 analogs typically require weekly or daily dosing, and oral agents such as orlistat are taken three times daily, our product’s dosing schedule remains under investigation with the aim of achieving a less frequent and more patient-friendly regimen.

Side Effect

Oral administration is expected to mitigate common injection-related side effects, such as localized reactions and systemic gastrointestinal issues frequently observed with GLP-1–based therapies. In addition, by modulating endogenous GLP-1 secretion rather than introducing exogenous receptor agonists, our approach may lead to a more favorable safety and tolerability profile.

Weight Loss Efficacy

Although direct efficacy comparisons will require clinical validation, our mechanism—which targets hydrogen sulfide–induced metabolic dysfunction—aims to provide durable weight loss with reduced risk of weight regain, a known limitation of several existing therapies.

Product

Our product is an innovative oral medication for obesity treatment, delivered via encapsulated live biotherapeutic products (LBPs) to ensure targeted release in the intestine. It functions by promoting insulin secretion, delaying gastric emptying, and regulating appetite—effectively restoring metabolic balance, enhancing fat metabolism, and reducing fat accumulation to support sustainable weight loss. To enhance patient support, we provide 24-hour online consultation services for continuous guidance and adherence assistance.

Price

Table 1 Our Product's Price

During the protection period (particularly for first-in-class drugs or breakthrough therapies), the state maintains price stability by capping reimbursement negotiation reductions and deferring inclusion in centralized procurement. After the protection period expires, innovative drugs may be included in centralized procurement (VBP),leading to a greater extent price reduction. If generics or biosimilars enter the market after the expiration of patents, there will be substantial price reductions.

Place

The product will be distributed through a multi-channel approach. In hospitals, access will be achieved via the Pharmacy and Therapeutics Committee using pharmacoeconomic data, with products supplied through large-scale wholesalers serving broad hospital and pharmacy networks. Additionally, we will partner with clinics and retail pharmacies through authorized distributors to expand patient accessibility across diverse healthcare settings.

Promotion

Promotion will integrate professional and digital channels. In the medical system, we will engage key opinion leaders and departments through expert lectures and department meetings to drive prescription adoption. On social media, we will share science-based weight management content, complemented by authentic patient testimonials to softly introduce product benefits. Furthermore, exhibition participation at international health and weight management events will raise awareness among professionals and influencers, strengthening brand credibility.

Our primary market consists of end-users whose needs can be categorized into the following segments:

Patients with Clinical Obesity

This core segment includes adults with a BMI≥30, or a BMI≥28 accompanied by at least one obesity-related comorbidity (e.g., type Ⅱ diabetes, hypertension). They seek a safe and effective long-term therapeutic solution for sustainable weight management and health improvement.

Individuals Pursuing Aesthetic & Lifestyle Goals

This group consists of generally healthy adults (BMI 24-28) seeking pharmacological aid for short-term body shaping objectives, such as preparing for special events. They value convenience, rapid results, and a non-invasive treatment option compared to invasive procedures.

Patients with Complex Comorbidities

This segment includes individuals with complex health challenges, such as binge-eating disorder, obesity linked to psychiatric medication use, or mobility-limiting conditions that prevent exercise. Their treatment requires close medical supervision to ensure drug safety and compatibility with existing therapies.

We have thoroughly planned our growth strategy. Our business model outlines key steps, resource and activities for development.

Figure 5 Our Business Model Canvas

‌Phase 1: Lab-based Tests & Experiments (2025-2027)

This stage involves constructing recombinant PET28a plasmids carrying genes encoding SQR and FCSD enzymes, followed by transformation into E. coli BL21 competent cells for protein expression. Successful gene insertion and the H₂S degradation efficiency of the enzymes will be confirmed through DNA sequencing, gel electrophoresis, and enzyme activity assays. Concurrently, venture capital funding and government research grants will be sought to support subsequent R&D activities.

Phase 2: Animal Studies (2027-2029)

Animal experiments will be conducted using mouse models with elevated H₂S levels. After oral administration of the product, changes in intestinal H₂S and GLP-1 levels will be monitored, along with overall health, gut microenvironment, and immune response. If adverse effects are observed, adjustments will be made to enhance safety, such as modifying gene expression conditions or dosage.

Phase 3: Prototype Development & Partnership Outreach (2028-2031)

A capsule or tablet prototype containing the engineered bacteria will be developed, and documentation for ethical review will be prepared. Simultaneously, partnerships with pharmaceutical and biotech companies will be pursued through industry conferences, workshops, and strategic meetings to facilitate technology transfer and collaborative development.

‌Phase 4: Pre-Clinical & Clinical Trials (2032-2035)

Upon obtaining ethical approval, small-scale human safety trials will be conducted to monitor any adverse reactions. Formulation and dosage will be further optimized based on human trial data. Effectiveness will be evaluated by analyzing changes in gut microbiota, H₂S reduction, GLP-1 secretion, and improvements in weight and glucose levels.

‌Phase 5: Commercialization & Scale-Up (2035 and Beyond)

Commercialization efforts will be initiated in parallel with late-stage R&D. These will include applying for government subsidies, preparing for an IPO, and securing partnerships and investments to enable large-scale production. Strict quality control and enhanced safety standards will be established, along with targeted marketing campaigns. Collaborations with hospitals, pharmacies, and online platforms will facilitate product launch, while long-term safety monitoring and global market expansion will be pursued.

Figure 6 Risk Management

Our project has identified key risks across critical phases and developed corresponding mitigation strategies. To address potential funding shortages, we will actively pursue biotech grants from sources such as the NIH and EU Horizon programs while also engaging impact investors. If protein secretion efficiency in strain engineering proves low, we will expand signal peptide library screening and utilize computational prediction tools. To prevent delays in regulatory approval from the FDA or EMA due to our novel mechanism, we will collaborate with regulatory consultants and conduct rigorous preclinical safety studies. Should scale-up production face challenges like high costs or low yields in industrial fermentation, we plan to license strains to partners with GMP facilities and optimize growth conditions. To compete against established GLP-1 drugs like semaglutide, we will emphasize our product's natural mechanism and reduced side effects. Finally, to overcome patient skepticism regarding microbial-based therapies, we will initiate pilot studies with wellness clinics and publish peer-reviewed data to build credibility.

Figure 7 Our Financial Planning

Our financial projections were structured according to the key phases of development, reflecting the high initial investment typical of bio pharmaceutical companies, followed by a gradual transition to profitability.

During the first three years (experimental phase), annual costs were estimated at approximately $6.2 million, covering laboratory and office space, equipment depreciation, labor, utilities, and raw materials. Initial funding was supported by government subsidies and early-stage financing, resulting in a net annual loss of around $5.6 million. As the company progressed into animal studies and prototype development (years 4-7), costs increased to an average of $14.3 million annually due to expanded R&D activities and the addition of pilot-scale factory space. Losses accumulated during this period, reaching a total of -$18.4 million by year 7.

The preclinical and clinical trial phase (years 8-10) saw annual costs rise to approximately $17.3 million, driven by higher labor, factory, and raw material expenses. By the end of this stage, cumulative losses peaked at -$33.2 million.

Revenue generation began in year 11 with market entry. Sales revenue grew from $68 million in the first year, with a gradual decline in subsequent years due to anticipated market competition. Despite high production costs—estimated at $470 per unit initially—and significant ongoing expenses for large-scale manufacturing and promotion, the company achieved profitability within the second year of sales (year 12). Cumulative profit turned positive by year 14, reaching approximately $41.8 million.

These estimates were based on a conservative market penetration assumption and remained consistent with industry benchmarks for biopharmaceutical manufacturing costs and facility investments.

Our team made up of 14 high school students. We divided our team into two groups— dry group and wet group. The main ability of dry group includes design, programming, product management, investigate and survey, interview, education and so on. The main ability of wet group includes experiment, method improving, scientific research and so on. Some work such as education combined the help from both two groups. Work in cooperation with the division of the students help each student utilized their talents and made our project more efficient.

The figure below respectively shows the interest and the impact of each possible stakeholders. The x-axis represents interest level, ranging from negative attitude on the left to positive attitude on the right. The y-axis represents impact level, ranging from negative impact at the bottom to positive impact on the top. The figure below classifies various kinds of stakeholders associated with our product based on different degrees of relevance and clearly represents them on the graph, this helping us better identify our target customer groups.

Figure 8 Stakeholder Analysis

Typical Case 1: Person with Obesity

Figure 9 Person with Obesity

This product promotes sustainable weight management, mitigates associated symptoms, and enhances patient’s self-confidence. Hence, person with obesity may occupies high interest and high impact in the figure.

Typical Case 2: Person with Diabetes

Figure 10 Person with Diabetes

By regulating H₂S level in the intestine, the drug enhances GLP-1 secretion to stimulate the insulin and improve the balance of body glucose. It also plays an important role on curing diabetes but the effect on patients and the understanding of the principle of drug action may not be so direct comparing with other traditional diabetes drugs.

Typical Case 3: Biotechnology R&D Company

Figure 11 Biotechnology R&D Company

Proprietary access to this innovative therapeutic target enables monetization via licensing or M&A. It helps enterprises to make innovations and increases company’s revenue. So these companies may show high interest and have great impact on buying the drugs.

Typical Case 4: Media and Social Platforms

Figure 12 Media and Social Platforms

Social influencers, creators and vloggers may create a trend of Weight Loss and Figure Anxiety. their pictures and stories would somehow encourage their followers to imitate them: adopt strict and even unhealthy diet or take drugs in order to lose weight and become more , so-called attractive. However, when the creators gain benefits from "quick-fix" weight loss stories and highly filtered or photoshopped selfies, it promotes the anxiety of body shape in society, which potentially increase the level of drug abuse.

Typical Case 5: Medical Insurance Providers

Obesity patients often require long-term use of the drugs so that it increases extra underwriting costs for medical insurance companies, which creates a conflict of interest. If they do not cover all these medications, they may face the pressure from the public. Consequently, medical insurance providers often have less interest on new weight-loss drugs and perceive the risks as higher.

1. Improved Public Health with Potential Cost Reduction

Our project addresses the global challenge of obesity and type II diabetes by offering an oral enzyme-based therapy that enhances the body’s natural GLP-1 production through modulation of gut hydrogen sulfide levels. This approach provides a more physiologically aligned treatment compared to direct receptor agonists. By enabling large-scale production through efficient fermentation, we aim to supply an affordable solution that may help lower long-term healthcare costs associated with obesity-related complications.

2. Sustainable and Scalable Manufacturing

The use of biological fermentation for producing SQR and FCSD enzymes represents an energy-efficient and environmentally friendly alternative to traditional chemical synthesis. This method reduces hazardous waste associated with injectable formats and supports scalable production with a lower carbon footprint.

3. Educational Alignment with Global Health Goals

This initiative helps raise public awareness of the gut-metabolism axis, emphasizing the role of hydrogen sulfide in metabolic health. It supports United Nations Sustainable Development Goal 3 (Good Health and Well-being) by promoting innovative and accessible health solutions.

1. Uncertain Long-Term Safety and Immune Response

As a novel biologic formulation, the potential for varied individual immune reactions and long-term effects of regular enzyme intake remains incompletely understood.

Mitigation: Comprehensive pre-clinical and clinical studies will be conducted across diverse participant groups to monitor safety, allergy risks, and immune responses, with adjustments made as necessary before product launch.

2. Regulatory and Public Perception Challenges

The innovative nature of enzyme tablets and the use of genetically engineered production systems may raise regulatory and public concerns around GMOs and novel therapeutic categories.

Mitigation: We will adhere strictly to all food and drug safety regulations, maintain full transparency regarding production and purification processes, and clarify that the final product contains purified proteins—not GMOs—to build trust and ensure compliance.

3. Risk of Exacerbating Health Inequalities

If priced without consideration for accessibility, the product could remain out of reach for low-income populations, who often experience higher rates of obesity and diabetes.

Mitigation: We plan to engage with public health programs and pursue tiered pricing strategies to ensure broad and affordable access, particularly for vulnerable communities.

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