Appearance
SOD Shield: Novel Eye Drops Prevent Oxidative Cataracts
1. Market opportunities and user demand
1.1 Background and trends
Cataracts are a common ophthalmic disease and the leading cause of blindness worldwide, especially in an aging society. There are more than 94 million patients worldwide, with 20 million new cases per year. With the deepening of the aging of the Chinese population, the burden of cataract disease continues to rise. Epidemiological studies have shown that the prevalence of cataracts increases step with age, reaching approximately 73% in the elderly population (85–89 years) [R1]. Based on the GBD framework, the total number of cataract cases in China reached about 18.14 million in 2019, and the number of cases and disability-adjusted life years (DALY) showed an upward trend between 1990 and 2019 [R2]. On the treatment side, the cataract surgery rate (CSR) in China has increased significantly in the past decade, jumping from less than 800 cases per million in 2010 to more than 2,000 cases per million in 2018 [R3], but there is still a significant gap compared with the > of 12,000 cases per million people in developed countries such as the United States and Japan [R4]. This means that a large number of early and mid-stage patients are still in the "unsurgipated" or "waiting period" stage, forming a huge potential market for conservative interventions.
Driven by clinical and policy directions, China's cataract market will expand two major sectors at the same time in the next five years: "surgical increment" and "waiting period intervention". The latter is still a blank space in the existing treatment pathway. This eye drop project can reduce surgical dependence on waiting period for intervention and prevention, solve the problem of disease, reduce the medical burden, leverage the tens of billions of market, invest with low risk and high return, and have huge market opportunities. Let's take a step ahead and focus on eye drop projects that will fill gaps in the market and have high growth potential and have been scientifically proven to be effective in preventing them.
1.2 User pain point insights
Patients with early cataracts usually have a slow progression and atypical symptoms, making it difficult to detect and receive effective intervention in time. At present, it is often recommended to "wait for the opportunity for surgery", but there is a lack of systematic "waiting period intervention plan" support, which makes a large number of patients fall into the dilemma of long-term anxiety and visual function decline.
Most of the existing products on the market are soothing or nutritional eye drops, which mainly relieve eye discomfort, but lack active ingredients for the pathological mechanism of cataracts and cannot really delay the process of lens clouding. Patients generally expect to have a product that can be used for a long time, has low side effects, and has pathological intervention to delay the progression of the disease and even reduce the need for surgery while waiting for surgery.
1.3 Project overview and value proposition
Cataracts are mainly caused by opacity caused by lens protein degeneration, and age, environment, genetics, etc. are common causes. Common causes include:
Age-related factors: The incidence rate of people over 50 years old is as high as 50%, and over 80% over 65 years old (global aging is intensifying, such as China's population over 65 years old has exceeded 200 million).
Environment and lifestyle habits: UV exposure (30% of cases), diabetes (2-5 times increased risk), smoking, malnutrition (e.g., vitamin C/E deficiency).
Other factors: genetics, eye trauma, or long-term use of hormonal drugs. The accumulation of these causes leads to oxidative stress and free radical damage, which is a key entry point for prevention.
There are more than 94 million cataract patients worldwide, with 20 million new cases every year (WHO data). Current treatment is mainly surgery, but the cost of surgery is high (average $3,000/case), accessibility is low (there is a large gap in developing countries), and preventive programs are scarce, forming a huge unmet need. Our eye drops project directly addresses this pain point, reducing surgical dependence and medical burden, and not only solves the root cause of cataracts, but also leverages the tens of billions of blue ocean markets, with low investment risk, high returns, and billions of dollars worth of market opportunities.
The current cataract treatment market is mainly focused on the level of "postoperative recovery" or "remission", and there is a lack of solutions that can intervene early on the pathogenesis itself. Most of the existing eye drop products are moisturizing or nutritious, such as glutathione and vitamin eye drops, which have a relatively mild mechanism of action and are difficult to substantially block lesions caused by lens free radicals. At the same time, a large number of patients with early cataracts and high-risk groups (such as diabetics and people with high myopia) are in the "waiting for surgery" stage, and there is a lack of available and recommended conservative treatment options by doctors, forming a huge treatment gap.
2. Prevention mechanism and scientific innovation
Prevention principle and mechanism: Based on the cause, eye drops block cataract development through multiple mechanisms: Eye drops block cataract development through multiple mechanisms such as antioxidant, anti-glycation, anti-inflammatory and nutritional supplementation. It is the first prophylactic formulation that is safe, convenient, low cost, and has a patent layout that enhances competitiveness.
Antioxidant protection: Contains ingredients such as N-acetylcarnosine, neutralizes free radicals, reduces lens protein oxidation (clinical studies have shown that it can reduce the incidence by 40%).
Anti-glycation effect: Inhibits the formation of AGEs (advanced glycation end products) for diabetes-related cataracts.
Anti-inflammatory and nutritional supplements: Vitamins and minerals (such as zinc and selenium) are added to enhance lens repair ability.
3. Market analysis (market positioning and differentiation)
The project conducted a market questionnaire in July 2025 with a valid sample of 306 people aged 14–66+, with 24.5% aged 51 and over.
(Consumer survey (n=306, Jul-2025, China, 51+, accounting for 24.5%); Non-random sampling, used only for directional insights, does not represent national population inferences. The core findings are as follows:
3.1 Cognition and reach
In the total sample, 34.0% of respondents had some understanding of "symptoms or treatments", and 54.7% had patients around them. In the 51+ year old segment, the reach rate of patients around them is higher, and their attention and motivation are significantly increased.
3.2 Intervention method preference
Among the total sample, drug intervention (such as antioxidant eye drops) was the first choice, accounting for 50.0%; This was followed by lifestyle intervention (36.3%) and nutritional intervention (13.7%). In the 51+ age segment, the propensity for pharmacological intervention was higher, validating the strong demand for non-operative drug regimens.
3.3 Purchase concerns
The top three concerns were: (1) worry about side effects/irritation (78.3%), (2) fear of unsafe ingredients (66.5%), and (3) concern that the effect is not obvious (52.4%). Among the elderly segments, the attention to effectiveness and safety is higher.
3.4 Product core element preference
Both the total sample and the elderly subdivision ranked efficacy and long-term safety as the two most important items, followed by comfort (no irritation of eye drops), durability (less frequent use) and economy (reasonable price). Among the 51+ year olds, the selection rates of "effectiveness" and "safety" reached 88.5% and 75.0%, respectively.
3.5 Packaging and price acceptance
For packaging, 5–10 mL/bottle was the mainstream (47.6%), which was suitable for household routine and on-the-go use. Among the total samples, 41.0% were ≤100 yuan/10 mL, and 62.7% were ≤ 200 yuan/10 mL. The acceptance of ≤200 yuan is higher in the elderly segment.
3.6 Typical user profile analysis
● Age group: 55 years old and above
● Geographical distribution: second- and third-tier cities and urban-rural areas, with fewer hospital resources
● Life status: Retired or semi-retired status, information acquisition channels are mainly based on the advice of relatives and friends, community doctors
● Emotional state: Strong perception of vision loss, fear of surgical risks but desire for conservative treatment
● Ability and willingness to pay: have a stable pension and are willing to invest 100~300 yuan/month to improve visual function
● Scenario 1: The patient was told in the community hospital that he was "not suitable for surgery" and lacked a reference for the treatment plan after returning home
● Scenario 2: Due to long-term blurred vision affecting the quality of life, try a variety of eye drops but no significant improvement
● Scenario 3: Children pay attention to the health of the elderly and actively look for "non-surgical alternatives" for them
● Scenario 4: Awareness of regular physical examinations is low, but more sensitive to reminders from children or doctors
● Scenario 5: Occasionally try health supplements (such as lutein, vitamins) to "prevent eye aging"
● Scenario 6: Fear of blindness, expecting to delay eye deterioration through diet and lifestyle improvement
Patients are willing to pay for products that are verifiably effective, long-term safe, easy to use, and want a doctor/pharmacist recommendation as a trust endorsement. For the elderly group, safety and effectiveness are absolute priorities, and price and convenience are pluses rather than determining factors.
4. Product mechanism and strategic positioning
Product Overview:
For early cataracts and high-risk groups, SOD enzyme-containing eye drops that can target the removal of lens free radicals and delay the progression of the disease are provided, filling the gap in scientific intervention before surgery. This project intends to develop an innovative eye drop containing high-purity, modified superoxide dismutase (SOD) for early cataract intervention. As a common and non-invasive method of administration, eye drops are easy to use, high adherence, and easy to popularize in home and primary medical settings. By intervening in the oxidative stress response in the early stages of cataract formation, it delays the process of lens opacity and helps patients delay or even reduce the need for surgery, thereby reducing the risk of multiple surgeries and the incidence of complications.
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4.1 Technological innovation points
Genetic modification path: Using PCR technology to amplify naturally extracted SOD genes, and screening and optimizing SOD mutants through ancestral sequence reconstruction and machine learning methods, the modified SOD shows better performance in terms of biological activity and temperature resistance, suitable for eye drop storage and stable use in multi-climate environments. Based on the core pathology of cataract formation – free radicals (ROS) continuously attack lens proteins and lipids – intervene directly from the source of oxidative stress.
SOD enzymes have three major mechanisms of action in this protocol:
Scavenge superoxide anions (O₂•⁻): Catalyze their dissociation into hydrogen peroxide (H₂O₂) and oxygen, reducing the free radical load at the source. [R5]
Synergistic antioxidant network: forms an antioxidant cascade with catalase (CAT) and glutathione peroxidase (GSH-Px) to efficiently decompose H₂O₂ into water and avoid secondary oxidative damage.
Protects lens proteins and antioxidant substances: maintains the solubility of α-, β-, and γ-lens proteins, and reduces the formation of insoluble aggregates; Increase reduced glutathione (GSH) levels, improve aqueous humor and serum antioxidant status.
4.2 R&D and application prospects
Short-term (1–2 years): Complete pharmaceutical studies, stability and safety evaluations of modified SOD eye drops, and initiate early clinical trials (for people with early cataracts).
Medium term (3–5 years): Conduct multi-center clinical trials in cooperation with tertiary hospitals and ophthalmology institutions; Expand to preventive use for high-risk groups such as diabetic cataracts and ultraviolet exposure occupations.
Long-term (5 years+): Build a closed loop of "early screening + intervention", combining wearable visual detection and community pharmacies to achieve national promotion of early and mid-term cataract prevention and treatment.
4.3 Market competition and strategic positioning
At present, cataract-related eye drops on the market are mainly divided into these categories: glutathione, vitamins, and postoperative care.
Glutathione: mainly used in the preoperative stage, aiming to improve the metabolic environment of the lens, but does not have the effect of directly treating cataracts; No prescription is required, and it is not a technological innovation. For example, Pinoxine eye drops, cataract stop eye drops, and Carlinyou eye drops.
Vitamins: mainly used as nutritional supplements to prevent or delay ocular degenerative changes, and have limited effect on cataract treatment; Usually no prescription is required, and technical barriers are low.
SOD enzymes (this project): by directly scavenging free radicals and inhibiting the oxidative aggregation of lens proteins, delaying the progression of cataracts from the etiological link, it can be used for early treatment, and it is also a new scheme with clear mechanism innovation. The target is OTC, and the final regulatory approval (Registration status TBD based on NMPA review) is expected to fill the market gap for early and mid-stage cataract intervention. Conclusion: Most of the existing products are at the level of nutrition or auxiliary care, and there is a lack of effective intervention for the cause. The SOD enzyme eye drops in this project have obvious differentiation advantages in terms of mechanism, applicability and technical originality, and the competitive barriers are higher.
4.4 Strengths- Weaknesses- Opportunities- Threats Analysis (SWOT)
4.4 Strengths- Weaknesses- Opportunities- Threats Analysis (SWOT)
| Strengths | Weaknesses |
|---|---|
| The mechanism is leading and the intervention mechanism is more accurate**.** SOD (superoxide dismutase) acts as a naturally occurring free radical scavenging enzyme in the body, It has significant antioxidant activity, can delay the oxidative aggregation process of lens proteins from the source, and has higher targeting and scientific intervention logic than traditional glutathione and vitamin C products. Theoretical innovation and obvious path differentiation. We have developed eye drops that target the removal of superoxide anion radicals from the lens and delay the oxidative denaturation of lens proteins at the source, using engineered highly active SOD enzymes as the core ingredient. This plan is different from the moisturizing or nutritional eye drops in the existing market. Starting from the pathogenesis of cataracts, aiming at the early pathological change process, it has the potential ability to "block the course of the disease", which belongs to the dual innovation of theoretical model and application mode. Good safety and compliance. As an endogenous enzyme component, SOD has high safety, non-addiction and low side effects. It is suitable for long-term use, especially for the preference of middle-aged and elderly people for "mild/sustainable" in chronic disease management. | Ingredient awareness is low**.** As an emerging intervention ingredient in ophthalmology, SOD currently has limited awareness among ordinary consumers and front-line pharmacists, and its mechanism of action and advantages still need to be educated in the market. The decision-making chain is long and the cost of education is high. The degree of product differentiation is high, and users have a relatively long conversion path under the premise of lack of doctor endorsement and clinical recommendation, which puts forward higher requirements for popular science education and trial mechanisms. Stability and cold chain logistics requirements need to be broken. SOD is an active protein substance, and if the final formulation is temperature-sensitive, it needs to be stored in the cold chain, which may increase transportation and storage costs and reduce the acceptance of retail channels. |
| Opportunities | Threats |
| Demographic dividend under the trend of aging**.** As the number of people over 60 years old continues to grow, the population base of cataract patients in China will continue to expand in the future, and conservative intervention products have long-term growth space.At present, the usage rate of cataract eye drops in our country is only about 5%, compared with mature markets such as Japan (15-20%), there is still room for 3-5 times the penetration rate to increase, which is a typical "low penetration, high potential" track. | Traditional competitors have strong cognitive and trust advantages. There are already mature products such as glutathione eye drops and vitamin B2/C eye drops in the market, which have a stable user base and doctor recommendation path at the terminal, which will form market resistance to new products in the short term. Uncertainty in policy supervision. If the state classifies SOD products into a higher regulatory level (such as prescription drugs or medical devices) in the future, it may face challenges such as extended registration cycles and complex approval processes, affecting the pace of product launch and sales. |
Our differentiators are:
Precise mechanism intervention: directly acts on the starting point of cataract pathology - the lens protein aggregation process triggered by free radicals
Safe and suitable for a wide range of people: As a human endogenous enzyme, it is suitable for long-term use, especially for early patients and high-risk groups
Surgical substitution window intervention: In the stage of "not yet meeting the indications for surgery", provide patients with a more scientific delay mechanism and psychological comfort
Potential preventive value: It has antioxidant protection for diabetes, high myopia, and the elderly, and can be used in advance
There is a long-overlooked gap in the cataract treatment market – a gap in scientific interventions for early and high-risk populations. While traditional eye drops mostly stay at the level of "symptom relief" or "auxiliary care", our SOD enzyme eye drops directly act on the pathological starting point of cataracts - the lens protein aggregation process triggered by free radicals, delaying the progression of the disease from the source. This means that this project can not only cut into a segment that has not yet been covered by mature products, but also effectively target a large and rapidly growing user base. In other words, the user's clinical need is real, and there are few direct competitors in the market for that need – providing an extremely favorable window for product commercialization.
4.5 Market feasibility judgment
Cost and pricing: Using the engineering high-activity SOD enzyme fermentation + purification process, the cost of a single agent is estimated to be less than 5 yuan, and it can be reduced to less than 3 yuan after mass production, and the gross profit space is sufficient; Referring to the market pricing range of high-end glutathione eye drops (68–98 yuan/bottle), this product has the dual advantages of price competitiveness and profit margin balance.
Supply Chain and Production Feasibility: Upstream SOD enzyme production can be cooperated with GMP-qualified biopharmaceutical companies to ensure stable supply at scale. Stabilized embedding technology can be introduced in the preparation process, which significantly reduces cold chain dependence and improves channel acceptance.
User Education and Penetration Path:
● Doctor's side: Establish doctors' trust through ophthalmology academic conferences, clinical trials, and core KOL science popularization;
● Pharmacist side: cooperate with pharmacy display, training and sales incentives to improve the recommendation rate;
● Patient side: Improve ingredient awareness and first-time conversion rate with the help of short videos, popular science articles, community lectures and try-on activities.
Channel layout rhythm:
● The first stage: OTC pharmacy + e-commerce flagship store entry to quickly obtain market feedback;
● The second stage: penetrate the ophthalmology specialty chain and tertiary hospital pharmacies to establish authoritative endorsements;
● The third stage: sink to community hospitals and grassroots pharmacies to improve coverage and repurchase rate.
Potential obstacles and coping strategies:
● Low ingredient cognition → Continue to strengthen the concept of "free radical scavenging" and bind the demand for delayed surgery for market education.
● Resistance to traditional competitors → Use clinical trial data and doctor recommendations to build trust barriers;
● Policy change risk → Simultaneously promote OTC and prescription registration paths to diversify compliance risks.
5. Business model and profit model
5.1 Product landing path
General principle: Drug registration is the main path (A route), and medical institution preparations/RWD (B route) are explored in parallel to reduce time and clinical uncertainty. All expressions such as "OTC/e-commerce sales" are subject to the final registration conclusion, and no efficacy commitment will be made before approval.
The project is expected to complete the entire process from core ingredient development to full market rollout within 5-7 years, adopting a four-stage promotion strategy of "prototype development→ clinical validation→ access approval, → commercialization" to ensure that the technological achievements match the market rhythm.
Path A:
| Stage | Proposed Timeline | Key Activities / Objectives | Milestones |
|---|---|---|---|
| Formulation & Process Lock (CMC-0) | 6-9 months | Formulation screening; evaluation of delivery systems (microcapsule/liposome, select one); comparison of packaging and preservative strategies; establishment of activity and purity analytical methods. | Intra-batch & Inter-batch RSD ≤10%; Activity retention ≥90%; Endotoxin (LAL) and microbial limits meet standards. |
| Pilot-scale & Stability (CMC-1) | 9-12 months (Can run in parallel with Non-Clinical) | 3 pilot batches (≥10L); ICH Q1A/Q1B stability protocol (accelerated/long-term/photostability/freeze-thaw); draft quality specification. | All accelerated (6-month) and long-term (12-month interim) stability time points pass; Formulation/process frozen. |
| Non-Clinical (GLP) | 12-18 months (Can run in parallel with CMC) | Ocular local tolerance, systemic exposure assessment, immunogenicity, genotoxicity (may seek exemption for enzymes), systemic/ocular toxicology; large animal studies (rabbit/dog) if necessary. | GLP study reports completed; primary safety conclusions support IND application. |
| Communication with CDE & IND Acceptance | 3-6 months | Pre-communication (meeting minutes); IND submission (CMC + Non-Clinical + clinical protocol); ethics approval; clinical trial registration. | IND Approval |
| Phase I (Safety/Tolerability) | 6-9 months | Healthy volunteers / small patient cohort; assessment of local/systemic adverse reactions and immunogenicity. | Safety meets pre-set criteria (discontinuation rate, manageable adverse events). |
| Phase II (Proof-of-Concept & Efficacy Exploration) | 12-18 months | Early cataract population. Primary endpoints suggested: Contrast sensitivity, glare radius, NEI VFQ-25 questionnaire. Secondary endpoints: LOCS III classification, objective lens opacity parameters. | Pre-specified effect size achieved (p<0.05 or meets non-inferiority/superiority margin). |
| Phase III (Confirmatory, Multi-Center) | 18-24 months | ≥8-12 tertiary/specialized hospitals; randomized, double-blind, controlled study; strict management of concomitant medications. | Primary endpoints statistically significant; safety profile acceptable. |
| New Drug Application (NDA) Submission | 6-9 months | Finalization of CMC data; on-site inspection / sample testing; compliance of package insert and labelling. | Market Approval (Rx/OTC status subject to approval document). |
Path B:
| Stage | Cycle | Key Points | Value |
|---|---|---|---|
| Feasibility Study for Medical Institution Preparation Partnership | 3-6 months | • Qualifications of specialized ophthalmic hospitals and their scope of preparation. • Target patient population. • Ethics approval and medication communication. • Not permitted for external commercial sales. | • Small-scale clinical application and experience. • Accumulates Real-World Data (RWD). |
| Small-Scale Clinical Observation | 6-12 months | • Define clear inclusion/exclusion criteria and endpoints (e.g., glare, contrast sensitivity, Patient-Reported Outcome questionnaires). • Strictly prohibited from publicly promoting efficacy. | • Generates publishable-grade Real-World Evidence (RWE). • Informs and optimizes Phase III clinical trial design. |
| Adjuvant Care Products (Non-Eye Drop) | 6-12 months | • Products that do not contact the ocular surface and make no efficacy claims.• Aims to build brand awareness and physician networks. | • Generates cash flow. • Increases brand exposure. |
5.2 Supply chain and technology verification
Positioning statement: Registered attributes (Rx/OTC) and marketable channels are subject to the final review of NMPA; No efficacy commitment will be made before approval.
5.2.1 Production mode (phased)
● P1|CDMO Small-Scale Certification (0–18 months): Select a dual-supply CDMO with experience in aseptic filling and ophthalmic formulations to complete prescription lock-up, 3 batches of pilot (≥10 L), and stability start-up.
● P2|CDMO scale-up (18–36 months): scale-up to ≥100 L for an annual supply of 100–3 million bottles; For clinical samples and pre-market stocking.
● P3|Self-built/long-term production line (36–60+ months): Gradually switch to reduce COGS, stabilize quality and supply.
5.2.2 Key materials and packaging materials (dual supply)
● SOD raw material enzyme (API): Escherichia coli expression (pET-28a), activity unit (U/mg), purity (SEC-HPLC), endotoxin (LAL) up to release standard; 2 fermentation/purification dual supply.
● Prescription and delivery: buffer system (pH 7.0–7.4) + homeostasis; H₂O₂ disposal strategies (synergistic with CAT/GSH-Px or chemical scavengers); Optional liposomal/microcapsule improves stability and corneal permeability.
● Packaging materials: preferential disposable small dose of preservative-free single bottle (BFS); If you use multi-dose bottles, use low-irritation and antiseptic and verify ocular surface safety.
5.2.3 Key points of quality and release
● Identity/Purity/Activity: SDS-PAGE, SEC-HPLC, Viability Units.
● Safety limits: endotoxin EU/mL, microbial limits, visible foreign bodies.
● Physicochemical: pH, osmotic pressure, (if any) particle size, content uniformity.
● Stability (ICH Q1A/Q1B): Accelerated for 6 months, long-term 12–24 months, light stability, freeze-thaw; Set a post-opening period.
5.2.4 Milestones (Financing Alignable)
● M1 Prescription/Process Freeze (90% Active≥ Accelerated June Point Qualification)
● M2 3 batches of pilot test passed + long-term December mid-term pass
● M3 GLP Non-Clinical Completion & IND Approved
● M4 Phase I./II. primary endpoint met (glare/contrast sensitivity/NEI-VFQ-25)
● M5 Phase III. Lock Library & NDA Acceptance
5.3 Revenue and profit model
| Cost Item | Description | Small-Batch Production (via CDMO) | In-House Production (Large-Scale) |
|---|---|---|---|
| A. SOD Active Pharmaceutical Ingredient (API) | Must meet release standards for activity & purity; cost based on median dosage and purchase price. | ¥6.0 | ¥5.0 |
| B. Excipients | Buffer salts, stabilizers, delivery system (liposome/microcapsule, select one). | ¥2.5 | ¥2.0 |
| C. Sterile Filtration & Filling | CDMO labor/equipment fees. | ¥4.5 | ¥2.8 |
| D. Quality Control & Release | Includes testing for activity, purity, endotoxin, microbial limits, and physicochemical properties. | ¥1.8 | ¥1.0 |
| E. Packaging Materials | Single-dose BFS (Blow-Fill-Seal) or multi-dose bottle (bottle/cap/dropper/box/insert/label). | ¥2.2 | ¥1.8 |
| F. Logistics & Cold Chain (if required) | Domestic controlled room temperature or 2-8°C shipping. | ¥1.2 | ¥0.9 |
| G. Scrap/Loss Rate | CDMO 3%, In-House 2% (weighted average applied to items A-F). | ¥0.6 | ¥0.3 |
| Total COGS per Bottle | ¥18.8 | ¥13.8 |
Pricing and channels are based on registered attributes: Rx first hospital/specialty chain + DTP; If it is OTC, first go to a professional pharmacy and then e-commerce after maturity. We set the retail price at ¥79/10 mL. Products are mainly sold through two channels: pharmacies and e-commerce.
● Suggested Retail Price (RRP): ¥79 / 10 mL
● Channel structure: pharmacy 60%|e-commerce 40%
● Pharmacy link deduction points: retail 40% + distribution 10%
● E-commerce link change fee: 15% of the platform + 4% of fulfillment + 1% of payment + ¥5/bottle of new marketing
● → Manufacturer (excluding tax)≈ ¥48.9/bottle
● Pharmacy: 79×0.6×0.9=¥42.7; E-commerce: 79−(11.85+3.16+0.79+5)=¥58.2
5.4 Marketing and marketing strategy
Registration attributes are preferred: Rx goes to "hospital/specialty chain + DTP"; If it is OTC, the "specialty pharmacy" matures before e-commerce.
Claim boundary: Externally, only use mechanism and experience expressions (such as "antioxidant mechanism, mild, convenient use"), and do not use curative terms such as "treatment/prevention of cataracts/delay cataracts/improvement of vision"; All materials go through compliance review.
5.4.1 Target population and motivation
| Segment | User Profile / Characteristics | Key Motivation | Typical Scenarios |
|---|---|---|---|
| 50+ Middle-aged & Elderly | Experience early-stage blurred vision and photophobia. | Desire gentle, long-term antioxidant eye care. | Community hospital recommendations, pharmacy consultations, children purchasing on their behalf. |
| Child Caregivers (Ages 35-55) | Adult children managing their parents' health. | Prioritize safety, trustworthiness, and ease of adherence. | Purchasing after health check-ups, repeat purchases via e-commerce. |
| High-Risk Populations | Individuals with diabetes, high myopia, or family history. | Seek daily antioxidant care as a preventive measure. | Self-management following a doctor's advice. |
| Medical/Pharmacy Professionals | Physicians, pharmacists, store managers, salesclerks. | Need compliant, easy-to-recommend products with supporting materials. | Providing supplementary non-prescription advice, in-pharmacy recommendations. |
5.4.2 Promotion channels
A. Rx Route (Prescription Drugs)
Academic side: Ophthalmology Annual Conference/Specialist Salon; RWD Observation Project; KOL co-authored a review.
DTP/specialty chain: doctor education leaflet, medication follow-up card, follow-up repurchase guide (QR code to join the group).
Pharmacy education: pharmacist speech card (mechanism/applicable scenario/precautions), monthly training.
B. OTC route (over-the-counter)
Pharmacy dynamic sales: end racks/displays, shopping guide SOPs, trial packs/samples; Membership repurchase vouchers.
E-commerce (after maturity): (1) Mechanism and security (2) Standardized usage (3) Professional endorsement (not equivalent to efficacy) (4) Real user experience (compliance).
C. Short video/social media:
Douyin: 1-minute "antioxidant trivia", lab highlights (compliance)
Xiaohongshu: Graphic notes "How to persist in long-term care" and "How to understand the ingredient list"
Official account/video account: Doctor Pharmacist Q&A, usage rules, Q&A compliance Q&A
D. Offline event scene
| Scenario | Format / Activities | Key Outcomes / Deliverables |
|---|---|---|
| Community Hospitals / Health Screening Centers | "Eye Care Corner" + Free Screening + Trial Samples | Lead Registration & Follow-up List |
| Pharmacies / Retail Chains | Loop Video Playback, Sales Staff Training, Member Day Experiential Activities | Member Tagging & Repurchase Coupon Distribution |
| Nursing Homes / Universities for the Elderly | Science Popularization Lectures + Care Kits | Word-of-Mouth Referrals & Family Group Promotion |
| Public Welfare Partnerships | Conduct Free Clinics & Popular Science Sessions with NGOs | Enhanced Brand Credibility & Public Exposure |
E. Science popularization and public welfare communication
| Target Audience | Educational Content | Format / Activities | Expected Outcomes |
|---|---|---|---|
| Target Group (Ages 55+) | "The 'Cleaner' in Your Eyes: How SOD Enzyme Protects the Lens" | Community Lectures, Pamphlets, Short Videos | Reach 200+ elderly individuals; 80% understand SOD's mechanism of action. |
| Adolescent / Student Group | "Re-engineering Enzymes with Synthetic Biology: From the Lab to Eye Drops" | Campus Open Days, iGEM Website Exhibition | Produce 3 educational videos; accumulate 1,000+ total views. |
| Public Welfare Partnership | Collaborate with local senior health associations to provide 500 free trial samples + free eye exams. | Community Free Clinics, Donation of Medical Supplies | Collect feedback from 80+ users to optimize product formulation. |
F. Growth funnel AARRR model
| Stage | Goal | Key Actions | KPI (Example) |
|---|---|---|---|
| Acquisition | Obtain leads & first-time store/page visitors | KOL endorsements, short videos, traffic from public welfare events | CPM ≤ ¥40; Cost Per Lead (CPL) ≤ ¥30 |
| Activation | First trial/order | Trial samples, post-lecture coupons, product bundles | First-purchase conversion rate ≥ 8% |
| Retention | Repurchase & course completion | 3-bottle/6-bottle treatment packs, community reminders | 60-day repurchase rate ≥ 28% |
| Revenue | Increase customer lifetime value (LTV) | Treatment plan upgrades, membership points | 90-day LTV ≥ 1.6 × first order value |
| Referral | Referrals (existing users bring new users) | Invitation rewards, points for reviews | Virality rate ≥ 12% |
5.5 Financial planning and financing strategy
Based on the current situation of China's cataract prevention and treatment market, the aging trend, and the differentiated advantages of this project in technology and mechanism, we expect that the product will go through three stages after launch: market education period→ penetration acceleration period, → brand expansion period.
| Year | Phase | Volume (10k bottles) | Mfr. Net Price (¥/bottle) | Revenue (¥' 0000) | Contribution Margin per Bottle (¥) | Gross Margin | Fixed Costs (¥' 0000) | Net Profit Margin | Break-Even Point (10k bottles) |
|---|---|---|---|---|---|---|---|---|---|
| 2025 | R&D Validation | 0 | - | 0 | - | - | 3,000 | - | - |
| 2026 | Clinical Advancement | 0 | - | 0 | - | - | 5,000 | - | - |
| 2027 | Market Education | 80 | 48.9 | 39,120 | 29.1 | 60% | 15,000 | 23% | 52 |
| 2028 | Penetration Acceleration | 300 | 48.9 | 146,700 | 32.0 | 66% | 18,000 | 54% | 45 |
| 2029 | Brand Expansion | 800 | 48.9 | 391,200 | 34.1 | 71% | 25,000 | 65% | Breached |
In 2027, in the first year of product launch, the revenue will be about 390 million yuan, limited by market education and fixed expenses, and the net profit margin will be about 23%.
In 2028, it will enter a period of accelerated penetration, with sales of up to 3 million bottles, revenue of about 1.47 billion yuan, and a net profit margin of 54%.
In 2029, the scale effect will appear, with sales expected to be 8 million bottles, revenue close to 4 billion yuan, and net profit margin of about 65%, fully breaking through the break-even point.
5.6 Capital requirements and use plans
To support R&D, clinical, registration and marketing over 5–7 years, we expect a total financing requirement of approximately $50 million, which will be phased in in Pre-A and Series A. The fund allocation plan is as follows: Capital ratio (R&D 40%, marketing 25%, production 15%, team 10%, compliance 10%)
| Purpose | Proportion | Amount (in '10,000 RMB) | Description |
|---|---|---|---|
| R&D and Clinical Trials | 40% | 2,000 | Includes formulation optimization, animal testing, and Phase I-III clinical trials. |
| Team Building and Operations | 10% | 500 | Core R&D, regulatory affairs, marketing, and operations team. |
| Marketing and Channel Expansion | 25% | 1,250 | Market education, healthcare professional promotion, and channel distribution. |
| Production and Supply Chain | 15% | 750 | Raw material production capacity building, cold chain, and quality control systems. |
| Compliance and Registration | 10% | 500 | Regulatory registration with NMPA, trademarks & patents, third-party testing and certification. |
Rhythm of fund use:
Angel Round (2025 Q3–Q4, 500–8 million yuan): Completed SOD engineering preparation and preclinical verification;
Pre-A round (2026–2027, 2,000–25 million yuan): Phase I–II clinical trials were promoted, and formulation formulation and stability verification were completed;
Series A (2028, 2,000–30 million yuan): Support phase III clinical trials, registration application and channel layout.
At the same time, the team will actively apply for policy funds such as major national science and technology projects and provincial and municipal pharmaceutical industry funds to reduce the pressure of equity financing.
Investor structure: biomedical industry fund + strategic pharmaceutical company + medical device leader (with channel resources)
5.7 Exit mechanism design
There are three main paths for investor returns:
Mergers and acquisitions: Domestic and foreign ophthalmic pharmaceutical giants (such as Santian Pharmaceutical, Aier Ophthalmology, China Resources Pharmaceutical, etc.) have expanded their early-stage cataract intervention pipeline through acquisitions;
IPO listing: Choose the opportunity to list on the Science and Technology Innovation Board or the Hong Kong Stock Exchange, relying on continuous research and development pipelines (such as anti-glaucoma and dry eye products) to form a long-term story;
Equity repurchase: After the brand forms a dominant market position, the founding team or strategic investors repurchase the shares of early shareholders.
Valuation reference model:
Based on the 2029 forecast, it is expected to have revenue of 3.9 billion yuan, net profit margin of about 30%, and net profit of about 1.2 billion yuan. According to the average price-earnings ratio of the industry is 25-30 times, the valuation range of enterprises can reach 300-36 billion yuan. For angel round investors, there is room for 8–12 times the return on investment in 3–5 years.
6. Compliance and risk management
6.1 Regulatory Compliance
As an ophthalmic eye drop project involving new active enzyme preparations, this product will strictly comply with relevant domestic and foreign laws, regulations and industry standards in the whole cycle of R&D, registration, production and marketing to ensure compliance and market access qualifications.
(1) Drug registration and approval path
The research and development and registration of this product will be completed in accordance with the requirements of the "Drug Registration Management Measures" (NMPA), and the phase I-III clinical trial and drug marketing registration application will be completed in turn.
If the regulatory authorities finally define the product as a prescription drug (Rx) or an over-the-counter drug (OTC), we will follow the corresponding registration category and review process respectively to ensure that the registration path is compliant.
In the R&D and clinical process, we comprehensively compare the guiding principles of ICH (International Technical Harmonization Committee for the Registration of Medicinal Products for Human Use) to ensure the scientific and traceability of data, and lay the foundation for future international registrations (such as CE and FDA).
(2) Production quality management (GMP)
The whole process follows the Good Manufacturing Practice (GMP), covering key links such as fermentation and purification of raw material enzymes, preparation filling, sterility testing, and stability inspection.
In the mass production stage, introduce and maintain the ISO 9001 quality management system, as well as the ISO 13485 system that meets the requirements of pharmaceutical products (if it involves medical device filing scenarios), to ensure that the quality system is in line with international standards.
Passed third-party quality inspection and batch release inspection to ensure the safety and stability of each batch of products.
(3) Intellectual property and trademark protection
The invention patent application for "Anti-cataract eye drops based on high stability SOD" has been initiated, and patent protection will be deployed simultaneously in the preparation process and delivery system.
Before the product is launched, complete trademark registration and brand protection to prevent market confusion and imitation.
Adopt a multi-level protection strategy of "patent + trademark + technical secret" to ensure long-term market barriers.
(4) Marketing and publicity compliance
Strictly abide by the "Advertising Law" and "Measures for the Review of Drug Advertisements" to ensure that all publicity materials are true, legal and verifiable, and there should be no illegal terms such as "treatment, cure, prevention, and efficacy guarantee".
All external publicity is limited to the ingredient mechanism, usage scenarios, and safety advantages, and shall not be exaggerated beyond the scope.
Establish an internal compliance review mechanism to conduct pre-audits of KOL cooperation, social media placements, and academic promotion materials to avoid the risk of violations.
The educational materials provided by doctors and pharmacists will be in popular science and compliance language to ensure sustainable promotion.
6.2 Risk identification and response strategies
| Risk Category | Specific Manifestations | Potential Impact | Mitigation Strategies |
|---|---|---|---|
| R&D & Technical Risk | Animal studies or clinical trials fail to meet endpoints; insufficient SOD stability. | Launch delays, increased R&D investment. | Conduct multiple parallel experimental batches; develop backup formulations; engage external CROs to improve trial efficiency. |
| Clinical Safety Risk | Subjects experience ocular irritation or adverse reactions. | Trial suspension or protocol amendments, increased compliance complexity. | Establish an independent Data and Safety Monitoring Board (DSMB); strictly adhere to GCP; pre-design withdrawal/rescue protocols. |
| Regulatory Approval Risk | Protracted NMPA review cycle; product re-categorization (Rx/OTC). | Delayed time-to-market, restricted sales scope. | Engage in early communication with NMPA on registration pathway; pursue CE/FDA filing in parallel to reduce single-market dependency. |
| Production & Supply Chain Risk | Insufficient API (SOD enzyme) production capacity; cold chain logistics volatility. | Increased COGS, unstable supply. | Sign long-term contracts with 2-3 CDMOs/OEMs; gradually build pilot and full-scale production lines; utilize stable encapsulation tech to reduce cold chain reliance. |
| Market Acceptance Risk | Low awareness of SOD among users/doctors, resulting in low prescription/recommendation willingness. | Low conversion rates, high market education costs. | Phased education: publish data post-Phase II; KOL/physician consensus conferences; community sample campaigns; establish patient education alliances. |
| Competitive Risk | Major pharma companies launch similar products. | Market share erosion, pricing pressure. | Secure key academic resources and sales channels; highlight "mechanistic differentiation + safety"; build a patent portfolio in advance. |
| Intellectual Property Risk | Patents are circumvented or infringed. | Market share erosion, reduced competitive barriers. | Implement multi-layered IP strategy: invention patents + design patents + trademark registrations + trade secret protection (e.g., for processes). |
| Financial & Funding Risk | Failure to secure expected financing; tight cash flow. | Slowed R&D progress, constrained team operations. | Adopt a phased financing strategy; apply for government grants and industry funds; establish meticulous cash flow management mechanisms. |
| Compliance & Reputational Risk | Marketing language or activities violate regulatory red lines. | Administrative penalties, diminished brand trust. | Establish a compliance review system; ensure all promotions strictly adhere to the Advertising Law and Drug Advertisement Review Measures; appoint a compliance officer for review. |
7. References
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[R2] Wu TH, et al. Time trends and gender disparities of Chinese cataract burden from 1990 to 2019, 2023.
[R3] 国家卫健委，《我国白内障手术率持续提升》，2018-06-10
[R4] Abdulhussein D, et al. WHO Vision 2020: Have We Done It?, 2023
[R5] Irwin Fridovich, Superoxide Anion Radical (O·̄₂), Superoxide Dismutases, and Related Matters, Available online 25 July 1997
[R6] Kaur J., et al. The Oxidative Stress in Cataract Patients (case-control study, 2012)
[R7] C. Zhang, et al. A trend analysis based on data from China, 1990 to 2021. 2025 [R8] M. Kulbay, et al. Oxidative Stress and Cataract Formation: Evaluating the Role of Antioxidants. 2024
[R9] C. Zhang, et al. Burden of Cataracts in Developing Countries: A Trend Study. 2025 [R10] L. Wang, X. Li, X. Men, et al. Research progress on antioxidants and protein aggregation inhibitors in cataract prevention and therapy, 2024
[R11] P. Yin, et al. Systemic inflammatory and oxidative stress biomarkers as predictors in second-eye cataract surgery, 2025
[R12] “Prevalence and associations of cataract in a rural Chinese population”
[R13] “The role of oxidative damage in cataract etiopathogenesis” (2023) [R14] Prevalence of cataract and cataract surgery in urban and rural China, 2022[R15] Knowledge of cataracts and eye care utilization among Chinese adults, 2022