ENTREPRENEURSHIP

Introduction

On the stage of iGEM, entrepreneurship serves as a crucial bridge connecting scientific innovation with practical applications. The SKLBE team, composed of young scientists and entrepreneurs filled with dreams and passion, is dedicated to addressing the global public health challenge of hyperuricemia through synthetic biology technology.

This business plan will comprehensively showcase the entrepreneurial philosophy, market analysis, product design, marketing strategies, financial planning, and risk mitigation measures of the SKLBE team, laying a solid foundation for the future commercialization of the project.

Brand Value & Vision

1.1 Entrepreneurial Background

Hyperuricemia, a metabolic disorder caused by purine metabolism disturbances or impaired uric acid excretion, has emerged as a significant global public health challenge. According to the U.S. National Health and Nutrition Examination Survey (NHANES 2007–2008), the prevalence of hyperuricemia among American adults is as high as 21.2%–21.6%, with gout prevalence at 3.9%, both showing significant increases over the past two decades. In China, the prevalence of hyperuricemia has reached 13.3%, affecting over 180 million individuals and showing a trend towards younger age groups, with the number of patients projected to increase to 230 million by 2029. Traditional treatment options primarily rely on drugs that inhibit uric acid synthesis or promote uric acid excretion, but these medications have notable side effects, including severe allergic reactions, increased risk of cardiovascular events, and exacerbated kidney burden. Therefore, there is an urgent clinical need for safe and effective new strategies to prevent and treat hyperuricemia.

1.2 Entrepreneurial Philosophy

The SKLBE team adheres to the core philosophy of “innovation-driven, health for the people,” leveraging synthetic biology technology to focus on the prevention and treatment of hyperuricemia and its complications. Our vision is to become an internationally leading supplier of super probiotics, providing global patients with safe, effective, and convenient solutions through continuous technological innovation and product development, thereby advancing the cause of public health.

Market Insight

2.1 Macro-environment Analysis

With the acceleration of global population aging and changes in lifestyles, the incidence of metabolic diseases continues to rise. Hyperuricemia, as a key player among these diseases, sees its market size expanding continuously. Simultaneously, China’s national policy support provides strong guarantees for the development of synthetic biology technology. The “Healthy China 2030” Plan explicitly proposes strengthening the comprehensive prevention and control of metabolic diseases and incorporating chronic disease management into key tasks. Furthermore, the “Chinese Guidelines for the Diagnosis and Treatment of Hyperuricemia and Gout (2023)” emphasize “early screening, early diagnosis, and early treatment,” encouraging the development of innovative therapies. The “14th Five-Year Plan” for the biomedical field lists synthetic biology as a frontier technology, supporting the transformation research of innovative therapies such as microbial therapies.

2.2 Industry Environment Analysis

The global microbial therapy market is expected to reach USD 7.68 billion by 2027, with a compound annual growth rate of 21.3%. In China, with policy support and industrial chain advantages, it is anticipated to capture over 10% of the domestic market share within the next decade. However, international competitors may accelerate their entry into the Chinese market, posing certain competitive pressures. Nevertheless, the SKLBE team, with its unique technological advantages and differentiated competitiveness, is poised to stand out in the market.

2.3 Target Audience Profile

• Asymptomatic hyperuricemia high-risk groups (China): Elevated uric acid without obvious gout symptoms, but strong preventive needs.
• Patients troubled by side effects of traditional drugs: Severe allergic reactions (e.g., allopurinol), increased cardiovascular risks (e.g., febuxostat), and kidney burden (e.g., benzbromarone) create demand for safer options.
• Younger hyperuricemia patients (China): Pay more attention to biosafety and long-term efficacy; key potential audience for YES301.

2.4 Market Size and Growth Trend

China has a vast number of hyperuricemia patients, trending younger. Based on our market research, if initially targeting gout patients, the market size is ~RMB 5.6 billion at a 10% penetration rate; if further covering preventive needs of asymptomatic high-risk groups, the potential market size exceeds RMB 10 billion at a 5% penetration rate. The rapid growth of the global microbial therapy market also provides broad prospects for our products.

2.5 Market Pain Points

Current drugs mainly include xanthine oxidase inhibitors (e.g., allopurinol, febuxostat) and uricosuric agents (e.g., benzbromarone), but they carry significant side effects. In contrast, YES301 regulates uric acid metabolism via the gut microbiota, offering high biosafety, precise efficacy, and multi-layered regulation, reducing side effects and improving quality of life.

Product Highlights

3.1 Engineered Probiotic YES301

YES301 is engineered to modulate intestinal purine/uric-acid metabolism as a safe, daily intervention. Expression is further optimized to enable the absorption of over 80% of extracellular purines within 30 minutes. Additionally, we introduced the uricase gene, forming a dual-regulation strategy of “source reduction + end acceleration clearance.”

3.2 Core Technologies

• Gene Editing: CRISPR/Cas9, Red recombination, Argonaute for directional chassis modification.
• Protein Rational Design & Directed Evolution: Structure-based computational analysis to improve functional proteins.
• Fermentation & Formulation Platform: From strain design and efficacy validation to scale-up; optimization of media, conditions, and downstream processes for synergy of growth and synthesis.

3.3 Product Advantages

• High Biosafety: Local gut action reduces systemic side effects and organ risks.
• Precise Efficacy: Fine regulation of intestinal purine absorption avoids excessive interference with global networks.
• Multi-layered Regulation: Co-expression of transporters and uricase achieves “source reduction + end acceleration clearance.”
• Technological Barriers: Patent strategy and confidentiality ensure exclusivity and leadership.

Digital Companion — Interactive Voice Assistant (UriGuard)

UriGuard uses our optimized “intestinal purine–serum uric acid dynamic model” so dosage outputs are model-driven. Inputs (dietary purine; age/gender/weight) are collected via guided voice questions (e.g., “Did you eat 100 grams of shrimp today?”). Beyond purine calculation & guidance, UriGuard offers disease education, multilingual (Chinese/English/French/Spanish), and timed reminders (“It’s time to take your medication”), improving adherence. We plan to iterate and ultimately release a lightweight app.

Growth Strategy

4.1 Product Strategies

• Development: Continuously optimize YES301; derivative products and dosage forms for different severities.
• Production: Strict GMP system; cooperate with qualified manufacturers for standardization and controllability.
• Optimization: Iterate formulations/packaging per market feedback to enhance user experience and compliance.

4.2 Pricing Strategies

Premium positioning with differentiated tiers by market affordability: high-end customized; mid-range cost-effective; entry basic (with charitable/free programs). Early promotions and patient assistance reduce burden and improve accessibility.

4.3 Channel Strategies

• Hospitals: Clinical research + physician education (rheumatology/endocrinology) to drive recognition and prescriptions.
• Retail Pharmacies: Chain partnerships; displays and consulting to raise conversion.
• E-commerce: Tmall/JD operations; livestream and time-limited campaigns to expand coverage.

4.4 Promotion Strategies

• Advertising: Medical journals, conferences, exhibitions; social video/animation.
• Public Relations: Patient association events, lectures, and free clinics to build trust.
• Sales Promotion: Time-limited discounts, BOGO, holiday offers.

4.5 Relationship Marketing

• CRM: Record info & purchase histories; personalize services; regular follow-ups and satisfaction surveys.
• Partners: Long-term supplier/distributor/hospital cooperation; secure materials; joint market expansion.
• Employees: Training and career development; team-building; communication/collaboration to boost efficiency.

4.6 Stage Goals

• Short-term (1–2 yrs): Complete preclinical & Phase I; obtain regulatory approvals; set up initial production & sales systems.
• Mid-term (3–5 yrs): Grow market share & brand influence; complete channels and service system; scale production.
• Long-term (5+ yrs): Continuous R&D; expand pipeline; become a global leader in synthetic-biology therapies.

Financial Outlook

5.1 Initial Investment & Fund Usage

• R&D: Gene editing, protein rational design, fermentation optimization — RMB 4 million.
• Clinical Trials: Phase I, II, III — RMB 3 million.
• Production Facilities: GMP workshop & equipment — RMB 3 million.
• Market Promotion: Advertising, PR, sales promotion — RMB 2 million.

5.2 Investment Return Predictions

Risk Management

6.1 Risk Assessment & Mitigation Measures

• Technical: Technology leakage and rapid iteration → confidentiality, patents, continuous R&D.
• Market: Demand changes and policy fluctuations → agile marketing, diversified layout, regulator communication.
• Financial: Funds recovery and cost control → strong financial management, diversified financing, cost optimization.
• Operational: Production delays/quality issues → strict production management, enhanced QC, contingency plans.

6.2 Security Assurance

• Product Quality Control: GMP/ISO-aligned lifecycle management, real-time monitoring, periodic 3rd-party audits, and a dedicated quality team for CAPA.
• User Data Privacy: Advanced encryption; strict access control; compliance with global data regulations; emergency response for breaches.

Social Value

7.1 Health Value

If successfully commercialized, the project will provide a safe and effective new treatment avenue for hyperuricemia patients, reducing severe adverse reactions caused by traditional drugs, improving quality of life, and alleviating disease burden.

7.2 Industry Value

The project will drive development of engineered bacterial therapies and create new economic growth points, boosting related industrial chains and employment.

7.3 Inclusive Value

By improving access to advanced therapy across diverse populations, the project helps reduce health disparities and ensures broader benefit from biomedical progress.

Full Business Plan

This section compiles the key content above—vision, market, product, growth, finance, risk, and social value—as the basis for subsequent commercialization, partnership outreach, and regulatory communication.