Summary

Why

• The problem of antifungal resistance is rising fast in China, especially in the Yangtze Delta region (a market share of 65.3 million).
• Current tools like WGS are expensive, slow, and static—they miss the real-time process and visualization of resistance evolution.
• CROs and pharma need faster, quantitative, and easy-to-use platforms to support antifungal drug development.

What

• Dr.sTraTeGY = Kit + Software for dynamic resistance tracking.
• Kit: engineered yeast strains with fluorescent clocks + mutation probes + reagents.
• Software: quantifies fluorescence, models resistance evolution, and exports ready-to-publish reports.
• Pricing: USD 18,000–38,000 per package; optional customization & service contracts.

How

• Structured in three phases (2025–2029+), focusing on pilot testing in the Yangtze Delta, national expansion, and eventual exit opportunities.
• Strengthened by complementary strategies, including SaaS licensing for software IP, tiered pricing models, and third-party distribution channels.
• Backed by expert validation (Shanghai Stock Exchange Cup, SoftBank China CEO), prioritizing IP protection, CRO partnerships, and targeted market segmentation.

Pre-research: the Antifungal medication market

1.1 Current business landscape

According to Fortune Business Insights, the global antifungal drugs market size is projected to reach USD 13.17 billion by 2027, with a compound annual growth rate (CAGR) of 3.3% during the forecast period ^[1]. With our estimation, the Chinese antifungal drugs market accounts for 25% of the global share (3.29 billion).

Since the advent of echinocandins, the worsening drug resistance crisis has made the development of antifungal drugs with entirely new mechanisms an urgent global need.

Moreover, current fungal infection treatments still face the following challenges, contributing to a significant market demand for new antifungal drugs:

In addition, the continuous growth of the elderly population, the rising prevalence of chronic diseases, and the increasing number of immunocompromised patients are all closely linked to the high disease burden and demand for antifungal drugs within these target groups:

• According to a study published in the Journal of Microbiology, Immunology and Infection ^[2], patients who have recovered from COVID-19 face a significantly elevated risk of developing fungal respiratory infections. The incidence of invasive pulmonary aspergillosis (IPA) within the studied population ranged from 19.6% to 33.3%. Consequently, since 2021, there has been a sharp increase in demand for antifungal medications.
• Based on data updated in September 2022 by the U.S. Centers for Disease Control and Prevention (CDC), onychomycosis (fungal infection of the fingernails and toenails) may affect up to 14% of the global population, with diabetic patients being particularly vulnerable. Among this group, dermatophytes (50%) and yeasts (30.8%) were identified as the most common cultured strains ^[3].

While these factors underscore the rising strategic importance of antifungal drug development, it is necessary to examine the practical process of antifungal drug R&D in greater detail to better evaluate the market landscape and opportunities.

1.2 The importance to study AMR

Currently, the preclinical R&D pipeline for antifungal drugs remains insufficiently robust. This is attributed to the lack of efficient and effective drug screening, which results in a relatively high attrition rate during early-stage drug innovation. Specifically, many drugs that appear promising in the preclinical phase fail in subsequent clinical trials due to various reasons, such as safety concerns and inadequate efficacy. The existing preclinical R&D pipeline is unable to offset the losses caused by these high attrition rates.

Through our desk research, the R&D of a drug pipeline usually has five stages: Drug Discovery, Pharmaceutical Research, Preclinical Research, Clinical Trial, Approval and Marketing. AMR testing typically focuses on the phase of pharmaceutical research.

In this stage, CRO usually takes the responsibility of drug screening for Drug manufacturers. CRO stands for Contract Research Organization, companies that provide outsourced research services to pharmaceutical, biotechnology, and medical device firms. Therefore, they usually conduct specialized works including AMR tests that allow drug developers to reduce costs, accelerate timelines, and access specialized expertise without building everything in-house.

Our solution: possible, scalable and inventive

2.1 Core Technology

At the heart of DR.sTraTeGY is the Grape Yeast multicellular chassis, engineered with targeted genetic modifications and modular extensions. This system integrates five functional modules to enable full-cycle tracking and analysis of fungal drug resistance evolution, offering dynamic insights that traditional endpoint sequencing cannot capture. The unique multicellular chassis turns the evolving population into a physical, spatio-temporal lineage tree, overcoming the limitations of static endpoint snapshots brought by unicellular systems.

2.2 MVP (Minimum Viable Product)

We will deliver Dr.sTraTeGY to our clients as a "Reagent Kit + Companion Software" tool package, consisting of three parts.

Core Reagent Components

• Tree-like multicellular grape yeast strains (pre-installed with fluorescent molecular clock and GPCR circuit);
• Multi-target mutation fluorescent probe set (covering common resistance-associated genes; customizable site-specific probes available);
• Signal inducers (to regulate the GPCR circuit), fluorescent detection buffer, and other supporting reagents.

Data Analysis, Software

• Fluorescence Quantification Module: Automatically detects fluorescence intensity and calculates mutation rates;
• Evolutionary Modeling Module: Generates evolutionary branching maps and mutation-generation prediction reports based on experimental parameters (e.g., drug concentration, culture time);
• Data Export Module: Exports results in formats compatible with Excel, GraphPad, and other tools for easy figure and manuscript preparation.

Auxiliary Tools

• Microscope-adapted slides optimized for fluorescence imaging;
• Standard Operating Manual;
• Technical Support Service.

Discover: Unmet needs in the Yangtze Delta region

3.1 The Gap in Drug Target Discovery

Currently, the escalation of fungal drug resistance and the lag in chassis organism models have led to a 24-year stagnation in the development of new classes of antifungal drugs.

The root cause of the inability to address the drug resistance issue lies in the lack of suitable chassis organisms, specifically because existing models have flaws. Single-cell systems cannot simulate the drug-resistant behaviors of biofilms or fungal populations.

The prerequisite for developing anti-resistance drugs is the precise identification of resistance mutation sites. However, traditional whole-genome sequencing (WGS) is costly, analytically complex, and faces four major challenges: lack of standardization, resource dependency, high expense, and ambiguous results. Therefore, we aim to leverage our technology to develop a toolkit that can track the evolutionary dynamics of fungal resistance under drug pressure.

3.2 Benchhead market

Located in the Yangtze River Delta (YRD) region, which includes Shanghai, Suzhou, and Hangzhou, this area is a hub for China’s biopharmaceutical industry, housing key players like WuXi AppTec and numerous innovative drug developers. Our decision to focus on this region is driven by four key factors:

Strong Industrial Cluster The YRD region has developed a robust R&D cluster, particularly around Shanghai's Zhangjiang Medicine Valley and Suzhou BioBAY, which together represent 25% of China’s clinical-stage anti-fungal drug pipelines. Zhangjiang Medicine Valley supports a full industrial chain, including gene synthesis and preclinical validation. In 2024, the park’s technical transaction volume exceeded USD 210 million. We estimate an annual investment potential of USD 28 million in anti-fungal drug pipelines.

Talent Pool Led by Zhejiang University of Technology, the YRD Green Pharmaceutical Collaborative Innovation Center is supported by top-tier institutions such as Zhejiang University and the Shanghai Institute of Pharmaceutical Industry. With 190 members, including 15 high-level talents, such as Chinese Academy of Engineering members and recipients of the National Outstanding Youth Fund, the center offers extensive expertise across pharmaceutical engineering, pharmacodynamics, and toxicology—key to advancing antifungal drug R&D.

Expanding Market East China is the primary growth engine for China's anti-infective drug market, valued at USD 6.8 billion in 2023 (36.7% of the national market). Projected to exceed USD 8.4 billion by 2025, it is growing at an 8.2% CAGR. The YRD region alone sees over 2.8 million annual dermatology outpatient visits, with a high density of pharmacies, providing a vast market for antifungal drug development.

Policy Support The YRD Pharmaceutical Industry Collaborative Development Plan prioritizes the establishment of joint R&D platforms for anti-infective drugs and accelerates regulatory processes for new antibiotics and antifungal drugs. To date, 4 Class 1 new drugs have been approved through priority review, enhancing the speed of antifungal drug R&D implementation.

By embedding ourselves in this ecosystem, we will gain:

• Direct access to a concentrated customer base.
• Opportunities for strategic partnerships with leading CROs.
• A thriving talent pool for recruitment and collaborative research.

3.3 TAM, SAM, SOM Analysis

TAM Analysis The Yangtze River Delta accounts for 39.7% of China’s antifungal resistance testing market. Given that the national fungal infection diagnostics market is projected to reach USD 3.29 billion by 2027, and assuming antifungal resistance testing represents 5%, the total national market would be approximately USD 164.5 million. Based on the regional share, the TAM in the Yangtze Delta is about USD 65.3 million.

SAM Analysis Our core target customers—CROs (70%) and research institutes/pharmaceutical R&D companies (30%)—represent 45% of the market. Adjusting for geographic accessibility, where 20% of CROs remain difficult to reach, the SAM is estimated at USD 23.5 million.

SOM Analysis In the presence of established competitors, a new entrant with technical, pricing, or network advantages could reasonably capture 20% of the SAM, resulting in a SOM of approximately USD 4.7 million.

Analyze: our Resources and Stakeholders

4.1 Product Advantages

4.2 PEST analysis

4.3 Our stakeholders

The stakeholder matrix is a widely used strategic tool to differentiate partners by their value contribution and engagement priority. Applying this framework, we identified three tiers:

• Tier 1 (CROs): Our primary focus. They hold the strongest purchasing power, have an urgent need for precise resistance tracking, and can rapidly validate our approach through pilot studies—making them ideal for early case studies.
• Tier 2 (R&D pharma and research institutions): Critical for credibility and downstream influence. They strengthen intellectual property, support publications, and broaden application scenarios, creating mid-term strategic value.
• Tier 3 (Public health, regulators, and policy stakeholders): Their benefits are societal and systemic, helping to drive market access, regulatory acceptance, reimbursement, and policy alignment. They typically come into play later or via partnerships.

Stakeholder Type	Representative Example	Interests / Needs	How DR.sTraTeGY Can Serve Them	Risks & Considerations
Tier 1 (Primary) CROs in China	Shanghai Medicilon Inc. — a leading R&D CRO based in Shanghai.	High-resolution, robust mutation/resistance data. Reduced time & cost vs whole-genome sequencing. Regulatory compliance, software/data export for analyses. Good support / training.	Offers real-time tracking of resistance emergence and quantitative mutation rates. Automation and software export help integrate into CRO workflows. Modular/pre-installed reagents reduce set-up time.	Need to demonstrate cost/time advantages over NGS/WGS. Learning curve, software usability, and microscope infrastructure. Pricing must be acceptable vs. CRO project budgets.
Tier 2 (Secondary) Other research institutions in YRD; Antifungal/Infectious Disease R&D pharma companies	Lizhu Pharmaceutical (cooperation on SG1001); Hansoh Pharma (partnership with SCYNEXIS).	Deep mechanistic insights to support drug candidate development. Usage in preclinical models / early drug efficacy study. Custom probe panels to monitor specific resistance genes. Publication / translational outputs.	Provides detailed mutation mapping and simulates evolutionary pressure under drug concentrations. Customizable panels allow tracking of relevant resistance mutations. Software outputs usable for academic papers and regulatory dossiers.	Require extensive proof/validation due to long R&D timelines. High expectations for data quality and reproducibility. May require certification/regulatory-grade assays.
Tier 3 (Tertiary/Indirect) Patients; Local health authorities; Hospitals & diagnostic labs	Local CDC in YRD provinces; Hospital mycology labs in Shanghai/Zhejiang.	Better diagnostics and earlier detection of resistant strains. Public health surveillance to track resistance emergence. Hospitals want reliable assays with understandable metrics. Patients want effective treatments.	Outputs could support hospital labs in diagnostics and inform clinicians. Health authorities can use aggregated data for stewardship policies. Potentially reduces treatment failures and hospital costs.	Slow adoption in hospitals; may lack equipment or trained staff. Regulatory approvals (IVD) needed for diagnostic use. Patient benefit is indirect and needs demonstrated clinical outcomes.

4.4 Team Members' capability

As a team with diverse backgrounds, we have members specialized in different areas, including: biology, Clinical Medical Science, software development, commercialization, public relations.

Dr. Meredith Belbin, the famous British management psychologist develop the Belbin Team Roles Theory in the 1980s ^[4]. His framework identifies nine distinct roles individuals naturally adopt in teamwork. The core premise of the theory is that no single person possesses all the skills or traits needed for a team to succeed. And it is essential to ensure each iGEM team member’s roles align, complements each other in the commercialization of our product.

Here is the visualization of our distribution of team roles of the 12 members:

4.5 SWOT Analysis

Based on SWOT, we will take the SO strategy: where we will leverage internal strengths to capitalize on external opportunities.

Leverage unique dynamic-tracking strength to position DR.sTraTeGY as the gold-standard tool for CROs developing antifungal drugs.

Bundle kit + software with CRO service workflows to tap into the rapidly growing outsourcing sector.

Partner with Yangtze Delta biotech clusters (Shanghai, Suzhou, Hangzhou) to capture nearly 40% of the national market first, then scale nationwide.

Use competition wins and expert endorsements to strengthen brand credibility and accelerate adoption in regulatory- and policy-driven biotech programs.

Differentiate with quantifiable metrics (selection pressure, mutation rates) to meet pharma demand for precision antifungal R&D.

Marketing: Business Strategies and Roadmap

5.1 Our mission

5.2 Pricing Strategy

With our understanding of stakeholders and YRD CRO / diagnostics kit markets, we will develop three suggested tiers for pricing.

Package	Contents	Suggested Price (USD)	Additional Notes
Basic	Standard reagent kit (tree yeast strain + core probes), core software (fluorescence quantification, evolutionary modeling), manual, 3-month tech support	$18,000	Lower margin for easier entry; potentially a subsidized/pilot price for early adopters; could include a consumable usage cap.
Professional	Adds customizable probes, advanced software features, priority technical support, potentially shorter training lead time	$28,000	Intended for mid-sized CROs doing repeated studies, or labs needing more advanced metrics.
Enterprise	Full probe customization, extended license (12 months+), higher usage volumes, potential onsite/bespoke modifications, premium support, software updates & modeling additions	$38,000 - $45,000	May include "consumables per run" pricing or subscription components for software updates.

Additionally, we also planned pricing strategy ABC to engage our first consumers:

A. Consumables / Per-Sample Add-ons: For labs / CROs not able to purchase full kits/licences upfront, you might offer per-sample reagents or per-run reagent bundles priced at e.g. USD 300-500 / sample depending on complexity, or "run" pricing (batch) to make it more accessible.

B. Software License / Maintenance / Updates: After initial sale, offer annual renewal/subscription for software updates / new models / cloud features in range USD 5,000-10,000/year for Pro and Enterprise clients.

C. Discounts and Pilot Offers: Early adopter discount (e.g. 10-20% off) for first few CRO clients in YRD in exchange for validation data / case studies.

5.3 Marketing Strategy

By linking these five strategic pillars, we will build a complete marketing funnel from brand awareness → interest generation → value validation → trust building → conversion & payment → word-of-mouth propagation. This integrated online and offline approach efficiently drives the commercial success of Dr.sTraTeGY, achieving brand building, lead generation, and sales conversion in a closed loop.

I. Brand & Corporate Image

Brand Positioning & Core Messaging:

• Positioning: The leader in dynamic antifungal resistance research solutions for drug development.
• Core Slogan: From Static Snapshot to Dynamic Evolution.
• Value Proposition: We provide the only integrated Kit + Software platform that enables real-time, visual tracking of the dynamic evolution of fungal resistance, helping CRO clients elevate their R&D efficiency to a new dimension.

Visual Identity System:

• Logo: Features a line-art puppy inspired by the shape of multicellular yeast clusters, creating an approachable yet scientifically grounded brand symbol.

• Color Palette: Primary Colors are Cyan and Orange; accent color is purple (echoing the grape yeast theme).

Typography & Imagery: Maintains clean, modern sans-serif fonts while continuing to utilize dynamic graphs, microphotography, and clean interface illustrations in a unified "scientific visualization" style.

II. Digital Marketing Strategy

Official Website – Integrated Interaction Hub

• Positioning: Not just an information portal, but the core platform for immersive product experience and sales lead conversion.
• Key Modules:
  • Interactive Product Tour: Embed an interactive module that simulates the software interface, allowing visitors to adjust parameters (e.g., drug concentration, time) and intuitively see simulated generated evolution maps and reports, strongly conveying product value.
  • Resource Center with Smart Gating: Place whitepapers, case studies, and other content behind forms to capture high-quality potential customer information.
  • Clear Calls-to-Action (CTAs): Prominently feature CTAs like "Schedule a Demo," "Apply for a Pilot Project," and "Contact Sales" across the site.

Precision Digital Advertising & Marketing Automation

• Ad Placement:
  • Platforms: Focus on LinkedIn and WeChat Official Account Ads.
  • Targeting: Precisely target users in CROs and pharma companies in the Yangtze River Delta with job titles like "R&D Director," "Project Lead," "Head of Biology."
  • Content: Use the "Dynamic Antifungal Resistance Tracking Whitepaper" download and online webinar invitations as core lead magnets.
• Marketing Automation:
  • After capturing leads via the website and ads, automatically trigger a nurturing email sequence. Content should progress from industry insights to deep product introductions, finally guiding towards a sales conversation.

III. Content & PR Strategy

Content Marketing:

• Expert Content: Publish the authoritative "Dynamic Resistance Tracking Whitepaper" to establish industry thought leadership.
• Case Study Content: Produce video versions of Customer Success Stories, featuring testimonials from 1-2 benchmark CRO clients, highlighting cost savings and reduced R&D timelines.
• Educational Content: Create the "Dr.sTraTeGY Academy" online video series for new customer training and potential client education.

Public Relations & Media:

• Systematically publicize milestone events like participation in the Shanghai Stock Exchange Cup competition and the meeting with SoftBank China CEO.
• Plan feature stories like "How an iGEM Team Solved a Billion-Dollar Market Pain Point" for placement in tech and biopharma media outlets like RedNote, 36Kr, and VCBeat.

IV. Event Marketing

Industry Summits:

• Goal: Go beyond exhibiting; lead the conversation. Strive for keynote speaking opportunities at all major industry conferences (e.g., China Drug R&D Annual Conference).
• Booth Design: Set up a "Live Dynamic Tracking Demo Zone" with a large screen broadcasting the experimental process live to attract traffic and create buzz.

High-Level Closed-Door Seminars:

• Regularly host "New Frontiers in Antifungal Drug R&D" closed-door seminars in Shanghai, Suzhou, etc., inviting no more than 20 decision-makers from target customers for in-depth technical exchanges and relationship building.

Online Webinars:

• Regularly host webinars focusing on specific technical challenges (e.g., "How to Quantitatively Analyze Resistance Mutation Rates") as a key method for acquiring lead lists and nurturing prospects.

V. Private Domain Marketing

WeChat Ecosystem Operation:

• WeChat Official Accounts:
  • Service Account: Used for important product updates, event notifications, and hosting functions like "Technical Support" and "Schedule a Demo," emphasizing service attributes.
  • Subscription Account: Used for daily content pushes to maintain brand activity and professional image.
• Enterprise WeChat:
  • Connect all inquiring customers and users who submitted forms on the website via Enterprise WeChat.
  • The sales and technical support teams use Enterprise WeChat for 1-on-1 professional communication and sharing expert content in their Moments (e.g., latest experimental data, technical tips), building an "expert" persona and establishing deep trust.

Customer Community Building:

• Establish an exclusive "Dr.sTraTeGY Pioneer User Club" community for customers who have made purchases.
• Within the community, prioritize releasing product updates, provide expert Q&A, host online exchanges, and encourage users to share experiences, fostering word-of-mouth and user stickiness to pave the way for upsells and renewals.

5.4 Other Strategies

5.5 IP Protection Strategy

Potential Intellectual Property Assets

• Patents: Core recombinant yeast strains (with fluorescent molecular clock + GPCR circuit); mutation probes; software algorithms (evolutionary modeling, branch prediction, mutation rate calculation).
• Trade Secrets: Specific probe designs/sequences; software source code; lineage tracking data (unique datasets).
• Copyright/Licensing: Software programs, operation manuals, user interfaces.

Protection Measures

• Deposit biological materials with designated depository institutions (e.g., China Center for Type Culture Collection - CCTCC). Submit patent applications via the electronic system of the China National Intellectual Property Administration (CNIPA), with claims covering the product, preparation methods, and applications in drug resistance research. Submit the deposit receipt and viability proof to CNIPA within four months of the application date.
• Leverage China's trend of strengthening IP judicial protection (utilizing the WIPO framework, patent courts) to safeguard rights. Simultaneously file PCT international applications via CNIPA, entering China and other target countries within 30 months to secure time for global layout.
• For pure software algorithms, consider copyright registration as supplementary protection, and employ trade secret measures such as source code encryption and licensing agreements.
• Protect lineage tracking datasets as trade secrets, supplemented by strict access controls and contractual agreements.

Commercial IP Strategy

• Licensing Authorization: Grant software/probe usage licenses to laboratories or CROs preferring not to purchase the full kit. Offer exclusive/co-exclusive licensing agreements to high-volume clients.
• Infringement Monitoring: Conduct regular market monitoring and promptly enforce rights through administrative or judicial pathways upon detecting infringement.

5.6 Business Exit Strategy

We listed four possible exit paths for Dr.sTraTeGY: typically 5-6 years from first commercial sales to either acquisition or IPO if all goes well (pMYTarket traction, regulatory compliance, scaling).

Exit Path	Description	Pros / Cons	Likely Valuation Drivers
Acquisition by larger diagnostics / biotech company	A company that sells diagnostic kits or an IVD/antifungal R&D company buys you for your tech, customer base, and IP.	Pros: Quicker exit, less risk of scaling; acquirer's distribution & regulatory power aids scaling. Cons: Might accept a lower valuation; integration risk.	Validated performance (clinical/pilot data), regulatory approvals, revenue growth, CRO customer list, defensible IP.
Licensing plus strategic partnerships	License the technology to different geographies or companies; possibly involve partial buy-outs.	Pros: Lower risk; retain ownership; recurring revenue; flexibility. Cons: Slower cash inflow; requires strong legal/IP infrastructure.	Value of licensing agreements, royalty streams, strength of contracts, robust and defensible IP.
IPO / public listing	Float on a Chinese board (e.g., Zhujiang Delta Market) or an overseas biotech-friendly market.	Pros: Potential for high valuation if growth is strong; brand and resource expansion. Cons: Burdensome regulations, public reporting, dilution, market risk; dependent on favorable market conditions.	Proof of scale, documented revenue growth, recurring contracts, a clear path to profitability.
M&A by CRO / service company	A large CRO might acquire DR.sTraTeGY to internalize the resistance-tracking capability.	Pros: Logical buyer with direct benefit from the technology; potential for strong synergies. Cons: Purchase price negotiation challenges; may command a lower premium than a product company.	Integration potential, cost-saving synergies, ability to scale the technology, overlap with the acquirer's customer base.

5.7 Business model canvas

Overlook: Impact and Plans for the Long Term

6.1 Expansion Timeline

With our product planning to exit in 5years, we planned the business timeline since 2026:

Phase	Timeline	Key Activities
Phase 1: Proof & Pilot	0-12 months	Regulatory groundwork; pilot studies with 2-3 CROs in YRD; gather data; refine kit + software UI; generate case studies/publications; set up IP filings.
Phase 2: Local Market Rollout	12-24 months	Full launch in YRD; onboarding of CRO clients; sales & marketing; refinement; support infrastructure; pricing optimization; consumables supply chain; begin expansion to other Chinese regions.
Phase 3: Product Maturation & Scaling	24-36 months	Expand probe panels; enhance software features (cloud, dashboards); automation; partner with reagent distributors; strengthen regulatory certification; build recurring contracts.
Phase 4: Geographic Expansion & Licensing	36-48 months	Enter other provinces in China; possibly Southeast Asia; license or partnership in non-China jurisdictions; consider export/IVD registration overseas; build brand internationally.
Phase 5: Exit Preparation & Growth Optimization	48-60 months	Solidify recurring revenue streams; profitability or path to it; clean financials; prepare for M&A or IPO; investor relations; possibly raise growth-stage capital.

6.2 Impact Assessment

Scientific Impact

Specific Impact Description	Likelihood	Mitigation & Solution Strategies
Positive: Provides dynamic, visualized data on resistance evolution, significantly enhancing understanding of fungal resistance mechanisms and potentially catalyzing new drug target discovery.	High	Continuously iterate technology; collaborate with top research institutions to publish high-impact papers; establish technical standards.
Negative: Risk of data misinterpretation. Model predictions might be overinterpreted, leading to erroneous research conclusions.	Medium	Provide detailed SOPs, data analysis guidelines, and user training; embed clear disclaimers and result interpretation notes within the software.
Negative: Technology imitation or circumvention. Competitors may develop more advanced or cheaper alternatives.	Medium-High	Build a robust patent portfolio; maintain technological leadership through ongoing R&D; establish brand reputation and customer loyalty.

Medical and Clinical Impact

Specific Impact Description	Likelihood	Mitigation & Solution Strategies
Positive: Accelerates R&D of novel antifungal drugs, potentially providing patients with more effective treatment options and improving clinical outcomes in the future.	High	Collaborate closely with pharmaceutical companies, using real-world data to demonstrate the platform's ability to shorten preclinical timelines.
Negative: If R&D decisions based on platform data fail, it could lead to resource waste and delay the development of truly effective therapies.	Medium	Clearly define the platform's scope and limitations, emphasizing its role as a "tool", not a "decision-maker"; integrate findings with other preclinical data for comprehensive judgment.
Negative: Biosafety risks. Accidental release of engineered yeast strains or probes could pose unknown risks to the environment or lab personnel.	Medium	Low Strictly adhere to biosafety level regulations; genetically engineer strains to reduce environmental survivability; develop and drill emergency response plans.

Economic & Social Impact

Impact Category	Specific Impact Description	Likelihood	Mitigation & Solution Strategies
Economic/Market Impact	Positive: Saves significant R&D costs and time for CROs and pharma, creating direct economic value; generates substantial revenue through sales and licensing.	High	Execute phased market entry and expansion strategy; adopt flexible pricing models; demonstrate clear ROI through case studies.
	Positive: Enables local Chinese biotech/diagnostic industry to capture more value in the global supply chain.	Medium	Form strategic partnerships with local companies; actively participate in industry ecosystem development.
	Negative: Market adoption slower than expected due to high switching costs and required infrastructure investment.	Medium	Offer pilot programs and early-adopter discounts; provide comprehensive technical support and training services.
Social Impact	Positive: Contributes to combating the global AMR crisis, improves public health, and aligns with UN Sustainable Development Goals.	Medium (Long-term)	Participate in public health initiatives; publish white papers; raise awareness among public and policymakers about fungal resistance.
	Negative: Societal controversy over GMOs. Public may have safety concerns about "genetic modification" of synbio products.	Low-Medium	Practice responsible innovation, maintain transparency; conduct public science communication; proactively engage with regulators.
	Negative: High prices may exclude resource-limited regions, potentially exacerbating healthcare disparities.	Medium	Consider preferential pricing for academic institutions; explore tiered pricing strategies for developing regions.

6.3 Financial Planning

Financial Projections & Assumptions

Item	Year 1	Year 2	Year 3	Year 4	Year 5
Number of CRO Clients (Full Kit Sale)	2	5	10	20	30
Revenue from Kit Sales	~$60k - $100k	~$300k	~$800k - $1,200k	~$2,000k - $3,000k	~$4,000k - $6,000k
Consumables / Re-order Revenue	Low	Growing	25-40% of Total Revenue	25-40% of Total Revenue	25-40% of Total Revenue
Software License / Maintenance Revenue	Small	Growing	~$100k - $200k/yr	~$100k - $200k/yr	~$100k - $200k/yr
R&D / Operational Costs	High (pilot studies, staff, regulatory)	High	Tapering in relative %	Tapering in relative %	Tapering in relative %
Gross Margin			Kits/Reagents: >60% after scale; Software: High after fixed cost amortization

Exit Valuation Estimate

Metric	Value / Multiple	Notes
Valuation Method	Revenue Multiple	Based on biotech/diagnostics sector benchmarks.
Typical Exit Multiple	8x - 10x Annual Revenue	Depends on growth, visibility, and IP strength.
Reference Data	Avg: ~9.7x Revenue Median Exit: ~$250M	Based on desk research in certain markets.
Scenario (Based on Year 5 Revenue)
Conservative (8x)	$32M - $48M
Base Case (~9.7x)	$38.8M - $58.2M
Optimistic (10x)	$40M - $60M

So possible exit values at different revenue levels:

• If Year 4 revenue is USD ~2-3 million, exit might fetch USD ~16-30 million (if acquired).
• If by Year 5 revenue reaches ~USD 5-6 million with good margin, strong customer base, IP, then exit could be USD 40-60 million or more; with licensing, recurring revenue, or IPO, possibly higher.

Funding Needs & Use

• Seed / Pre-Series A (USD 1-2 million) for pilot, regulatory, initial sales / hiring.
• Series A (USD 5-10 million) around Year 2-3 to scale production, marketing, expand geographic coverage.

Return for Investors

• If exit in Year 4-5 at multiple revenues, investors in early rounds could see a 5-10x return, depending on dilution, growth.

Our Action

In March 2025, we participated in the National Innovation Competition, where we refined our business model and product presentation for the first time.

Later, in May 2025, we took part in the Biopharmaceutical Track of the Shanghai College Student Innovation and Entrepreneurship Competition (Shanghai Stock Exchange Cup), aiming to raise initial funding from potential investors through roadshows. Industry experts and judges provided valuable feedback in discussion sessions - for instance, experts recommended that we further segment our target customer groups in market sizing and strengthen the alignment of our product applications with clinical needs. Investors also highlighted the importance of early planning for intellectual property protection and building strong competitive barriers. Overall, these experiences sharpened our understanding of both our strengths and weaknesses, laying a solid foundation for product iteration, market expansion, and fundraising strategies in the future.

In June 2025, we had the privilege of engaging in a face-to-face discussion with Mr. Jie Chen, CEO of SoftBank China. During the meeting, we presented the development concept, market positioning, and future roadmap of our core product, DR.sTraTeGY, highlighting its potential applications in antifungal resistance testing and drug discovery. Mr. Chen emphasized the importance of establishing benchmark collaborations with CRO clients in the early stage to create demonstrative impact. He also reminded us to balance long-term capital planning with short-term cash flow management in our fundraising strategy. This exchange not only provided us with strategic insights from the investment community but also strengthened our confidence in driving the product toward industrialization.

On September 18, our team held a constructive meeting with the iGEM team from East China University of Science and Technology (ECUST) to discuss the commercialization plans of our respective projects. The dialogue covered business alignment, progress updates, and marketing strategies, while also clarifying each team's commercial focus and strategic logic.

We introduced our multi-cellular yeast tracking tool, targeting CROs in the Yangtze River Delta, along with the designed yeast strains and software package. Our exit strategy involves licensing the toolkit to CROs by the fifth year.ECUST shared their project centered on gout prevention through functional food, aimed at easing the burden on healthcare and patients. They addressed challenges such as public skepticism toward functional products and safety concerns regarding engineered bacteria, highlighting outreach as key to gaining acceptance.

Additionally, ECUST provided suggestions for our business plan, including:

1. Adding supporting data, patents, or authoritative certifications;
2. Including documents such as patent applications, after-sales guarantees, and user guides to enhance credibility;
3. Emphasizing favorable macro-trends and policy support;
4. Adhering to international standards to ensure safety and compliance.

The exchange was insightful and beneficial for both teams.

References

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