Allergies have become an increasingly prominent public health issue globally. The World Health Organization (WHO) lists allergies as one of the top three health concerns of the 21st century, emphasizing the need for comprehensive prevention and control strategies, including drug therapy, environmental control, patient education and immune regulation. The World Health Organization (WHO) estimates that about 30-40% of the world's population (about 2.5 billion people) suffering from allergic diseases, including allergic rhinitis, asthma, and food allergies.

In April 2025, Xinhua News Agency reported that China has 300 million allergy sufferers, and the White Paper on the Allergy Status of Chinese Residents, jointly released by China CDC and several tertiary first-class hospitals, shows that the proportion of the allergic population nationwide has reached 31.2%. According to the Guangdong Allergy Prevention and Control Health Science Popularization Project, nearly 40% of Guangdong province’s population suffers from allergic diseases each year—making it the region with the highest number of allergic rhinitis sufferers in the country. The primary allergen in Guangdong is house dust mites, and symptoms are especially prone to be triggered in enclosed spaces such as air-conditioned rooms. Moreover, common allergens such as pollen and seafood (particularly shrimp and crab) also cause significant allergic reactions. In particular, pollen allergies are widespread during specific seasons, while shellfish allergens—through tropomyosin cross-reactivity with dust mites—have a high prevalence in coastal regions.

The high incidence of allergies has led to a growing demand for effective treatment methods, creating a broad market space for micro-needling allergy-treatment technologies. People want healthcare that's less invasive and focuses more on them. Also, microneedles for delivering drugs are getting better.

Therefore, by using microneedle to solve the problem of allergy, patients can eliminates frequent clinic visits required for allergy shots, and unlike subcutaneous injections, micro-needling is minimally invasive, improving patient adherence. Additionally, micro-needling method to cure allergy can also reduces systemic exposure, lowering risks of severe allergic reactions.

Our microneedle-based allergy vaccine addresses these gaps by translating research into accessible care. We aim to:

• Enable at-home self-administration, cutting hospital visits and easing needle fear for children and busy adults.
• Target three local key allergens (dust mites, pollen, seafood) in one vaccine, filling unmet regional needs.
• Minimize pain and systemic exposure, expanding access to high-risk or needle-averse users.
• This commercialization aligns with China’s 2025 biomedical innovation policies and reduces the ¥120 billion annual healthcare burden of allergies (China CDC, 2024). Our core mission: turn scientific progress into tangible help for the 1 in 3 people affected by allergies.

Figure 1: Our Business Ethics

We are committed to:

• Safety first – Strict compliance with China’s Biosecurity Law and global ethical standards.

• Patient-centered innovation – Prioritizing painless, safe, and convenient treatment.

• Sustainability – Use of biodegradable microneedle materials to minimize medical waste.

• Transparency – Ethical communication with patients, regulators, and partners.

Figure 2: Advantages of Dissolvable Microneedles

Our product, Allergone, is an innovative multi-allergen immunotherapy vaccine delivered through biodegradable microneedle patches. It combines biotechnology with advanced drug delivery to fundamentally improve allergy treatment.

Allergone integrates two key components:

1. Recombinant Allergen Proteins – Engineered antigens from three major allergens prevalent in China and Asia (dust mites, pollen, and seafood). These recombinant proteins are designed to reduce IgE binding (minimizing severe allergic reactions) while preserving T-cell reactivity, allowing the immune system to build tolerance.

2. Microneedle Patch Delivery System – A dissolvable patch containing micron-scale needles that painlessly penetrate the skin barrier. This system enables controlled and localized antigen release, reduces systemic side effects, and can be safely self-administered at home.

Unlike conventional treatments that only relieve symptoms temporarily, Allergone targets the root cause of allergies through long-term immune modulation. Its nature is that of a disease-modifying, patient-friendly, and scalable therapy suitable for both children and adults.

Figure 3: The unique advantages of our microneedles product

We compare our product Allergone with seven allergy-related drugs across six key factors, including painless, suitable for long-term treatment, specialized on allergen treatment, affected by other diseases or not, and versatility. Each product is evaluated based on whether it meets or fails to meet these criteria, with "✓" indicating a positive attribute and "×" indicating a negative one.

Here is a list of products compared:

• Astero
• Zyrtec Allergy
• Preclone
• Dupixent
• Alomide
• Afrin
• Allergone

As the need to reduce patient discomfort, minimize anxiety and fearassociated with needles, improve compliance with medical treatment has risen these year, painless has also become a big contributor while choosing medicine. According to our research, more than half of the drugs on sale have a side effect of irritation. For example, Alomide and Afrin are oral medicines that could cause irritation, while Dupixent is an injectable medication, and is not currently administered via microneedle technology. Many patients have claimed that the Dupixent injection is very painful, and they are afraid that some disease may be infected by needles. Astepro, Zytrec allergy and Prelone don’t have such concern as they are all oral drugs, and these drugs may taste bitter, but won’t cause any irritation. Our product, Allergone, which takes microneedling as an injection method, won’t cause any irritation while injecting.

Different medicines have different functions. For example, Asterom Zyrtec Allergy, and Afrin are drugs that ought to ease symptoms temporary, and these drugs are not suitable for long-term treatment as they have some rebound effects if used for long times. However, medicine like Prelone, Dupixent, Alomide don’t have rebound effect and can be used for long-term treatment and consistent injections to cooperate with Immunotherapy. While Allergone was designed to be a part of Immunotherapy. Allergone is highlighted as a viable option for long-term treatment, positioning it as a strong contender for managing persistent allergies. According to our research, patients nowadays are looking for “eliminate” rather than “easing”, while we can combine both methods together to make the process less pain.

None of the existing products (Astero, Zyrtec Allergy, Prelone, Dupixent, Alomide, Afrin) specialize on a specific allergen. This suggests that these treatments may have broader applications but lack targeted efficacy against particular allergens. However, Allergone stands out as the only product marked as specialized on an allergen, indicating a potential niche market or advanced specificity in its mechanism of action. As I claimed, Allergone is a part of the Immunotherapy, as its alarm is the issue that cause allergy, Allergone is used to treat pollen, mites and fish (protein) allergy with Immunotherapy.

Prelone, Alomide, and Afrin are influenced by other diseases, which could complicate their use in patients with comorbidities. This factor highlights potential limitations in their applicability. Astero, Zyrtec Allergy, and Dupixent are unaffected by other diseases, making them more versatile for patients with additional health conditions. While Allergon is marked as unsure as the official iGem authority banned in vivo experiment, so we don’t know if whether or not Allergone will be affected by other diseases and cause complication.

Zyrtec Allergy, Prelone, Dupixent, Alomide, Afrin, and Allergone demonstrate versatility, meaning they can be used across various types of allergies or in different contexts. For example, Zyrtec can also be used to treat itching and swelling caused by chronic urticaria(hives), and Prelone can treat not only allergy symptoms but gland problems, blood problems and skin rashes. This broad applicability makes them attractive options for diverse patient needs. Astero lacks versatility, limiting its utility compared to the other products. Allergone is noted as versatile as it can be used in treatment of various allergens, further enhancing its appeal as a comprehensive solution.

Microneedles offer a minimally invasive, patient-centric platform for transdermal drug delivery and diagnostics. Their micron-scale design penetrates the stratum corneum without stimulating deeper pain receptors, enabling painless administration and improved compliance, particularly for chronic therapies such as allergy desensitization. Unlike traditional hypodermic needles, microneedles allow for self-administration at home, significantly enhancing flexibility for treatments requiring frequent dosing—a critical advantage in multi-year allergen immunotherapy protocols. Additionally, microneedles’ larger electrode surface areas provide higher currents, improving signal acquisition in diagnostic applications. This technology overcomes traditional limitations in macromolecule delivery, facilitating efficient transport of molecules such as proteins while bypassing gastrointestinal degradation or systemic side effects. Dissolving or hydrogel-based microneedles further enable controlled release of therapeutics, optimizing sustained immune modulation for applications like multi-allergen immunotherapy. These features position microneedles as a transformative tool for personalized medicine, addressing unmet needs in allergy treatment, and beyond through targeted, patient-friendly solutions. 

Figure 4: User Profile

Figure 5: Population of global allergy

The global allergy immunotherapy market was valued at USD 1.92 billion in 2024, driven by rising allergy prevalence and advancements in biotechnology (Grand View Research, 2023). Projected to grow at a compound annual growth rate (CAGR) of 8.7% from 2025 to 2030, this expansion underscores the urgent need for innovative solutions to address escalating allergic disorders (Grand View Research, 2023). According to Mordor Intelligence, the Asia-Pacific market is the fastest-growing region, a trend primarily driven by accelerated urbanization and worsening air pollution over the past decade.

Among the world's 8 billion people, about 320 million people suffer from allergies. Among them, 87.5% will choose desensitization treatment to get rid of the symptoms of rhinitis and rashes. Treating allergies is a long and expensive process, which means that our products have many advantages in terms of price and portability. Normally, the entire desensitization course takes three to five years, and during this period, the patient needs to go to the hospital almost every week for desensitization injections. The price of desensitization injections is also relatively expensive. The cheapest cost of the entire course of treatment is US$3,000, and the most expensive can even reach US$15,000.

A critical pain point lies in the lack of root-cause solutions. Current treatments merely alleviate symptoms and are often accompanied by side effects like drowsiness. Over 70% of patients express dissatisfaction with these options, underscoring the demand for therapies that address the underlying mechanisms of allergies (Allergy, 2014). Furthermore, conventional subcutaneous immunotherapy (SCIT) requires 3–5 years of frequent hospital visits, placing a significant burden on patients. This challenge is particularly acute in regions like China, where 250 million people suffer from allergic rhinitis, yet access to specialized care remains limited (Chinese Medical Journal, 2022). These gaps highlight the urgent need for innovation in precision medicine and patient-centric delivery systems to bridge the widening market gap.

WOLWOPHARMA Biotechnology Company

——Local Allergy Drug Research and Development Company in China

Figure 6: LOGO of WOLWOPHARMA Biotechnology Company

Company Overview: 

WOLWOPHARMA Biotechnology Company is a domestic biological research and development firm which founded in 2002. Dedicated to the development, production, and sales of diagnostic and treatment products for allergic diseases. In the Chinese allergy medicine market, they holds the largest market share for its independently developed allergy medications.

Treatment Methods: 

WOLWOPHARMA Biotechnology focuses on treatment methodologies based on desensitization therapy and stem cell therapy. The company specializes in the research and development of dust mite allergen treatments and is conducting studies on various allergens. Additionally, it is pioneering efforts to transition therapeutic drugs from traditional protein-based allergen preparations to locally sourced Chinese medicinal herbs and natural remedies.

Figure 7-9: Products of WOLWOPHARMA Biotechnology Company

Main Research Directions:

Development of different forms of allergy suppressants, including drops, skin prick tests, and skin prick fluids. Research into the inhibition of different types of pollen allergens.

Company Advantage: 

WOLWOPHARMA Biotechnology has successfully established a stable customer base within China, particularly benefiting from its unique personalized immunotherapy solutions. These solutions include dynamic immune testing and adjustable treatment plans, offering a level of flexibility that is rarely seen in the field of immunotherapy. This tailored approach sets WOLWOPHARMA Biotechnology apart as a leader in the domestic market.

Customer Group: 

Primarily targets individuals suffering from dust mite allergies.

Price: 

Approximately 100-170 yuan/2ml.

Stallergenes Greer

———Global Allergy Treatment Company

Figure 10: LOGO of Global Allergy Treatment Company

Company Overview: 

Stallergenes Greer is a fully integrated global biopharmaceutical company specializing in Allergen Immunotherapy (AIT) for the diagnosis and treatment of allergic diseases. The company has a significant market presence in both Europe and North America, offering a wide range of allergen-specific therapies to patients.

Treatment Methods: 

Stallergenes Greer provides treatments for a broad spectrum of allergens, including pollen, dust mites, mold, and pet hair. Their primary treatment products are:

·Sublingual Immunotherapy (SLIT): Oral lozenges or drops.

·Subcutaneous Immunotherapy (SCIT): Injection-based therapy.

Figure 11: Product of Global Allergy Treatment Company

Main Research Directions: 

The company focuses on continuous innovation in the field of allergen treatment, aiming to:

·Reduce treatment duration.

·Improve the overall effectiveness of immune therapy.

·Lower patient rejection rates during treatment.

Their commitment to cutting-edge research is evident in their collaborative efforts with global research institutions, driving innovation in allergen treatments.

Company Advantage: 

Stallergenes Greer boasts significant global partnerships with research institutions to support its product development efforts. The company excels in offering customized, long-term treatment plans for patients, ensuring effective and personalized allergen management.

Customer Group: 

Patients with a variety of allergic diseases, along with healthcare professionals who prescribe and oversee allergen immunotherapy treatments.

Price:

 Approximately $500/box.

ALK

Company Overview

ALK is a ALK is a company with 100 years of experience in researching anti allergic treatments. They aim to help people take control of their allergy and their life.

Treatment (method)

Injections- Subcutaneous allergy immunotherapy (SCIT) is allergy immunotherapy given as regular injections under the skin. The treatment is administered by a doctor.

Sublingual drops-Sublingual allergy immunotherapy (SLIT) drops are administered under the tongue. Patients administer the drops themselves at home, avoiding the need for regular visits to the doctor.

Tablets SLIT-tablets are administered by the patient at home and are the best-documented AIT treatment. Tablets for house dust mite, grass, ragweed, and Japanese cedar allergies are already available in many markets.

Main research direction

Their research focus on 3 main parts, diagnosing allergy, Allergy immunotherapy (AIT) treatments and Treatment of acute allergic reactions. Their treatments focus on allergen sources such as grass pollen, tree pollen and house dust mites.

Advantage (technology)

1. Digital eco-system: aim to connect with ‘the other 99%’ by building an ecosystem of information, services and products that complement the company’s core portfolio.
2. Diagnosis of specific allergies: in skin prick tests.

Unique production: raw materials-natural allergens e.g., grass pollen, house dust mites.

3. Purification: double purification-active pharmaceutical ingredient.
4. Adrenaline pen: acute life-threatening allergic reaction.

Customer group

Individual that is suffering from allergen sources such as grass pollen, tree pollen, and house dust mite.

Circassia Ltd

Company Overview

DBV Technologies is a global clinical stage biopharmaceutical company founded by pediatricians who believed that food allergies could one day be treated safely and effectively. They use their innovative technology the VIASKIN patch to advance epicutaneous immunotherapy, and they are exploring on the first epicutaneous immunotherapy treatment for peanut allergy.

Treatment (method)

VIASKIN patch

The VIASKIN® patch has a dry allergen in the center, placed on a film over the skin. When applied, a small space forms between the allergen and the skin. Moisture from the skin collects in this space, dissolving the allergen (shown in green). Once dissolved, the allergen enters the top skin layer (epidermis). Inside the skin, immune cells called Langerhans cells pick up the allergen. Animal studies show the allergen stays in the epidermis and does not reach the bloodstream. The Langerhans cells then move to the lymph nodes, where they help create special T cells that stop the allergic reaction.

Main research direction

Their research focus on treatments for food allergies, especially on the development of the VIASKIN patch technology.

Advantage (technology)

They use an advance technology called VIASKIN patch. It is a new class of treatment that is designed to treat allergy through the skin. This may provide a non-invasive treatment for the patients. VIASKIN patch can deliver microgram number of allergens to the immune system through intact skin. Their research on EPIT aims to target specific cells in the skin, like Langerhans cells, to activate the immune system. Preclinical studies show that these cells catch allergens and move to the lymph nodes, where they activate special regulatory T cells (Tregs). The Tregs activated by EPIT (using VIASKIN® patches) can reduce the Th2-driven response to allergens, helping to block allergic reactions.

Customer group

Children between 1-17 who faced food allergy.

Webpage

dbv-technologies.com

Figure 12: Our Target Customers

S: The target market for our Allergy Immunotherapy can be divided into several groups. Firstly, children with allergies (such as mites, pollen, and seafood) who are afraid of or experience pain from traditional desensitization injections due to the use of long, pointy needles. Secondly, adults with allergies are looking for a more comfortable and less invasive solution to manage their allergies. Third, health-conscious individuals and busy professionals who seek convenience, at-home treatments that save time and avoid frequent doctor visits. Overall, parents of children dealing with these specific allergies want a less painful and more convenient way to treat their children’s conditions. Therefore, targeting these customers can help publicize and customize our product.

T: The main target customers are parents of children with allergies, particularly those who need a less painful and more stressless solution for desensitizing their kids. Additionally, adults with common allergens like mites, pollen, or seafood, who want a comfortable and efficient alternative to traditional allergy shots are also key targets. The product will also appeal to “busy individuals and health-conscious people” who need convenience and value their allergy treatment options and prefer a solution that can be done at places such as their home. This helps to easily integrate our Desensitization Microneedles into their daily routines.

P: Our Allergy Immunotherapy is positioned as a pain-free, efficient, and convenient alternative . towards traditional allergy shots. It provides a target treatment for mite, pollen, and seafood allergies that’s designed to be least intrusive, fast, and easy to use. This solution is an advantage for those who want a simple and effective way to manage their allergies without the discomfort or time commitment of doctor visits. Additionally, for families, it’s a gentler at-home treatment that makes desensitization easy and unconstrained for both children and adults, offering an efficient, targeted approach to allergy relief.

A course of treatment costs 7200 RMB

Suggested unit price: 300 RMB/piece

Suggest using one patch per week for six months (adjustable, extended to twelve months for severe allergies)

Pricing reason:

We have referred to the pricing on the market, and compared to traditional desensitization therapy (with an average annual cost of 20000-50000 RMB), the pricing of microneedle patches conforms to a differentiated competitive strategy. Using microneedle patches does not require professional methods and is more convenient and efficient. In addition, the advantages of using microneedle patches at home can increase acceptance.

Figure 13: Our Promotion Method

Political

China’s government strongly supports allergy immunotherapy through policies that emphasize biomedicine innovation, regulatory reform, and integrated development plans. This creates a favorable environment for R&D and market expansion.

Economic

The allergy immunotherapy market in China is experiencing rapid growth, driven by increasing allergy cases, especially among children and the elderly. Although R&D costs are high, long-term healthcare savings and strong investment support make the market economically viable.

Social

Public awareness of allergies and their long-term effects is rising, especially with an aging population and increasing pediatric allergy rates. There’s a growing societal focus on improving quality of life, boosting demand for safe, effective treatment options.

Technological

China is advancing rapidly in immunotherapy with strong technical capabilities. Innovations like gene editing and cell therapy are accelerating R&D, while new approaches are improving treatment success rates.

Legal

China enforces a rigorous drug approval process that includes strict preclinical and clinical trials, detailed regulatory review by the NMPA, and mandatory post-market safety monitoring, ensuring product safety and compliance.

Environmental

Sustainability is a key consideration, with strict controls on emissions and wastewater in production. The industry also promotes biodegradable packaging and low-emission logistics to reduce its carbon footprint.

Figure 14: PESTEL Model

This Porter’s Five Forces analysis evaluates the competitive landscape of the allergy immunotherapy market using microneedle technology. The bargaining power of customers is moderate, as the target market is generally well-educated, and the product’s convenience reduces pressure from buyers. The bargaining power of suppliers is high due to the limited number of suppliers for key raw materials like hydrogel, PVA, and HVA, and the need for high-quality inputs. The threat of new entrants is low because rigorous clinical trials and high R&D requirements create strong entry barriers. The threat of substitutes is moderate, as there are many existing alternatives, but the unique value of the product makes switching less attractive. Industry rivalry is high, with many existing brands and similar products, though differentiation—such as targeting triple allergens—may help reduce direct competition over time.

Figure 15: Porter's five force Model

Figure 16: SWOT Model

Figure 17: Business Canvas

Key Activities

The company focuses on research and development, gaining necessary approvals, promoting its product, and expanding partnerships. It also emphasizes scaling up production to meet growing demand.

Key Resources

Core resources include a skilled team, advanced technology, lab equipment, and sufficient funding to support R&D, production, and operations.

Key Partners

Partnerships are built with government bodies, supply chain providers, market channels, and research institutions to ensure smooth operations and innovation support.

Value Propositions

The product offers a painless, convenient, and cost-effective solution for allergy treatment. It targets multiple allergens, and emphasizes environmental ethics and sustainability.

Customer Relationships

Strong, long-term relationships are developed through trusted partnerships with hospitals and customer education to build credibility and confidence.

Channels

The product reaches customers via local agents, official online platforms, and collaborations with government agencies for broader distribution.

Revenue Streams

Revenue comes from product subscriptions, regular delivery services, public health partnerships, and potential technology licensing agreements.

Cost Structure

Costs include fixed expenses like R&D, infrastructure, and manpower, alongside variable costs such as raw materials, marketing, and logistics.

Customer Segments

Primary customers are children and busy adults with allergies. Secondary targets include medical institutions and health management agencies.

6.1.1 Stage 1: Research and Development in the Lab (First 12 months)

In the first stage, our priority is to build a highly skilled and cohesive team, foster a collaborative environment, and develop a functional prototype that directly addresses the targeted problem of allergy treatment. This period will emphasize innovation, feasibility studies, and the initial proof of concept, ensuring that the scientific and technical approach is validated. To achieve this, we will recruit and onboard experts in relevant fields such as biochemistry, immunology, and product development, while clearly defining roles and responsibilities to maximize efficiency. Preliminary research, experiments, and data analysis will be conducted to generate foundational insights. Meanwhile, the prototype will be refined iteratively to ensure its robustness. All findings will be carefully documented to guide the transition into the next stage. This phase is designed to be completed within 12 months.

Milestone

By the end of this stage, we expect to have achieved a functional prototype or proof of concept that demonstrates the feasibility and viability of our proposed solution.

6.1.2 Stage 2: Experimentation, Testing, and Regulatory Approval (First o18 months)

The second stage is focused on rigorous testing and regulatory compliance, ensuring that the product is safe, effective, and reliable. This is a critical step for building trust with both regulators and stakeholders. Our plan includes designing and executing controlled experiments that validate product performance, as well as conducting comprehensive safety and toxicity testing in line with international regulatory standards. Data collection and analysis will support claims of efficacy and safety, forming the basis of our regulatory documentation. Submissions will be made to agencies such as the FDA and EMA, and we will address all feedback or requests from these authorities. The expected timeline for this stage is one and a half years.

Milestone

Successful completion of this phase will be marked by securing official regulatory approval, which allows the product to advance toward commercialization.

6.1.3 Stage 3: Market Entry and Initial Marketing (First two years)

Once regulatory approval is obtained, the third stage will focus on launching the product into the market and establishing an initial customer base. This stage emphasizes creating market awareness, building trust with early adopters, and generating the first streams of revenue. A comprehensive marketing strategy will be developed, including branding, positioning, and pricing. Messaging will be tailored to target demographics, supported by advertising campaigns across digital platforms, social media, and traditional channels. Distribution channels will be established in collaboration with healthcare providers and retailers to ensure accessibility. Simultaneously, we will monitor sales performance and gather customer feedback to refine strategies. To support scaling efforts, additional funding and investment will be pursued.

Milestone

The success of this stage will be reflected in generating initial profit and implementing an impactful marketing campaign that drives product awareness and adoption within the first two years.

6.1.4 Stage 4: Market Expansion and Customer Relationship Strengthening(One yearafter stage 3)

Following successful market entry, the fourth stage will deepen customer relationships and expand market presence, with the ultimate goal of maximizing profitability while demonstrating impact in allergy treatment. Customer retention strategies, such as loyalty programs and personalized support, will be implemented to enhance satisfaction and trust. Feedback mechanisms will be established to gather insights for product improvements and user experience refinement. At the same time, we will explore new markets and regions to broaden our reach and consider developing complementary products or services to enrich the portfolio. Stronger partnerships with healthcare providers, distributors, and stakeholders will be cultivated, while operational efficiency will be optimized to reduce costs and increase profitability. This stage is scheduled to be completed within one year after Stage 3.

Milestone

By the conclusion of this stage, we aim to achieve sustained profitability, expanded market share, and a strong reputation for effectively addressing allergy-related health issues.

6.1.5 Stage 5: Delivery（First 3 years)

The final stage centers on product delivery and long-term scalability. Efficient distribution systems and optimized supply chain logistics will ensure that products reach target consumers seamlessly, while customer onboarding strategies will be designed to maximize accessibility and market penetration. To strengthen customer loyalty, exceptional after-sales services—including technical support, warranties, and responsive care—will be provided, supplemented by structured feedback loops to refine service quality. Operational scalability will be pursued by replicating and optimizing delivery processes, leveraging automation and strategic partnerships to achieve economies of scale. Data-driven insights will further guide cost reduction efforts, ensuring that operational efficiency is balanced with high-quality standards.

Milestones

The success of this stage will be measured by two key milestones. First, market validation and iterative improvement will be achieved through continuous monitoring of market response, customer preferences, and competitive positioning. Insights from these assessments will guide refinements that enhance product-market fit and support sustainable growth. Second, profitability and sustainable growth will be realized by generating consistent revenue streams and achieving operational profitability. At this point, profits will be reinvested into R&D, marketing, and infrastructure, laying the foundation for long-term market leadership.

This stage is designed to be completed within three years, after which the process will loop back to Stage 3, allowing for renewed cycles of market entry and innovation.

Figure 18: Our Step and milestones

Figure 19: Finance Forecast in Excel

Sales:

Since the product has just been sold and the brand is not well-known, we expect to have 1500 customers to buy. Each customers

Priced at 300 yuan/product and each customers will need to use 4 products per month with 9-month course of treatment: The cost of microneedling is much lower compared to traditional desensitization therapies, so by setting a lower price than the community is now paying, you can reap the benefits of more customers.

Compound growth rate: 1.05%

Initial R & D: We expect to invest 10M RMB in R&D expenses. If the funds are insufficient we will replenish our investment by seek other investors or more strategic cooperation.

Land & Factory: We expect to spend 50M RMB 、land and building factories. Land costs 8,000㎡(Land area) × ¥3,000(cost/㎡) = ¥24,000,000. Factory costs 8,000㎡(Land area) × ¥3,250(cost/㎡)= ¥26,000,000.

Equipment: PCR, shakers, centrifuges, refrigerators, mass spectrometers, etc. are required in the laboratory, with prices varying, as determined by different properties. We expect that the demand for equipment will be high in production. Therefore, we estimate that the price of the equipment to be invested is about 10M YUAN.

Labor: We expect to build factories in second-tier cities in China, with an average monthly salary of 8,000 yuan. We expect to hire 7 people, totally annual salary is 672,000 Yuan.

Power: We estimate that monthly water and electricity costs are 50,000 yuan, totally 600,000 Yuan Annually.

Promotion: We would also expect to spend 200,000 yuan every year for marketing and contactc hospitals communication. We interviewed the laboratory researchers, and learned that the cost of test tubes and reagents in the laboratory is very low, so we estimate that the cost of each product is about 15 yuan. We hope to reach a profit in 5 years.

6.2.1 Sales Forecast and Market Strategy

Given that our product is newly launched and the brand is not yet well-established, we anticipate an initial customer base of approximately 1,500 users in the first year. Each customer is expected to undergo a 9-month treatment course, with an average consumption of four products per month. This results in 36 units per customer for the entire treatment cycle.

At a unit price of ¥300, the total revenue per customer over nine months is ¥10,800. Multiplying by the projected 1,500 customers, we estimate first-year sales revenue at ¥16,200,000. To ensure conservative yet realistic growth, we apply a monthly compound growth rate of 1.05%, reflecting gradual market penetration through brand awareness, physician recommendation, and word-of-mouth referrals. This growth strategy balances ambition with operational sustainability, allowing the business to scale responsibly.

6.2.2 Cost Structure

Research and Development (R&D)

We will allocate ¥10 million as an initial investment into R&D. This expenditure covers formulation development, clinical testing, regulatory compliance, and intellectual property protection. Should funds prove insufficient, additional resources will be raised through strategic partnerships or venture financing.

Land Acquisition and Factory Construction

To maintain full control over production standards, we will establish a dedicated manufacturing facility in a secondary city in China. The required land area is 8,000㎡, costing ¥24,000,000 at ¥3,000 per square meter. Construction of an 8,000㎡ GMP-compliant factory is estimated at ¥26,000,000, bringing the total investment in land and facilities to ¥50,000,000. This infrastructure will not only support initial production but also accommodate future expansion.

Laboratory and Production Equipment

Our production line will require high-precision instruments such as PCR machines, centrifuges, shakers, refrigerators, and mass spectrometers. Considering both laboratory and industrial needs, we estimate total equipment investment at ¥10,000,000.

Labor Costs

To optimize efficiency and cost management, the factory will be located in a second-tier city with favorable salary levels. We plan to hire seven employees across technical, production, and administrative roles. At an average monthly salary of ¥8,000, the annual labor cost will amount to ¥672,000. Additional staff will be recruited as operations scale.

Utilities

Ongoing costs for electricity, water, and waste management are estimated at ¥50,000 per month, resulting in annual utility expenses of ¥600,000.

Marketing and Promotion.

To build brand awareness and establish trust with both healthcare professionals and patients, we will invest ¥200,000 annually in marketing. This budget covers digital campaigns, hospital outreach, participation in scientific conferences, and collaborations with dermatologists and allergists.

Raw Materials and Unit Cost.

Consultations with laboratory researchers suggest that raw material costs—including reagents, consumables, and packaging—remain low due to economies of scale. We estimate a unit production cost of ¥15. Over a nine-month course, this equals ¥540 per customer. With 1,500 projected customers, the total Year 1 material cost is ¥810,000, enabling strong gross margin performance.

Overall, one-time capital expenditures (land, factory, and equipment) amount to ¥70,000,000, while recurring annual operating costs—including labor, utilities, and marketing—total approximately ¥1,482,000.

6.2.3 Break-even and Profitability Outlook

With a unit price of ¥300 and a unit cost of ¥15, the gross profit margin stands at 95%. This high margin creates significant scalability potential. We project that break-even will be achieved within five years, provided that customer acquisition follows the expected growth trajectory and operating costs remain controlled.

Key profitability drivers include:

• Exceptional gross margins resulting from low unit cost relative to price.
• Organic growth through community adoption, hospital partnerships, and increasing brand reputation.
• High initial capital investment, which reduces variable costs and secures long-term production capacity.
• Future potential for pricing adjustments once the product achieves market recognition and clinical validation.

The first phase of implementation will focus on completing the regulatory and commercialization steps in China, which will serve as the foundation for Allergone’s global expansion. The process begins with product classification, where Allergone will be formally assessed to determine whether it falls under drug, device, or combination product supervision. Following classification, we will initiate pre-clinical research, including pharmacological and toxicological studies as well as device-related validation, to ensure that our therapy meets safety and efficacy standards before entering human trials.

With sufficient pre-clinical data, we will apply to the National Medical Products Administration (NMPA) for clinical trial approval or exemption, allowing us to proceed with either formal registration studies or investigator-initiated trials. Once these clinical trials are completed, a full regulatory dossier will be submitted to NMPA in order to secure marketing authorization. Parallel to the regulatory process, we will also apply for manufacturing permits, including pharmaceutical production licenses or medical device production licenses, ensuring Allergone’s scalability within China’s highly regulated healthcare sector.

After regulatory approval and manufacturing readiness, we will enter the Chinese market by applying for inclusion into the national medical insurance reimbursement catalog, which is critical for physician adoption and patient accessibility. Marketing efforts will follow strict compliance rules while raising awareness among allergists and clinics. At the same time, we will prepare international submission data packages in ICH CTD format, building a bridge to global registration pathways.

Once Allergone establishes clinical and regulatory success in China, the second phase will target major international markets, including the United States, European Union, and Japan. The first step involves product classification requests: submitting RFD to the FDA, aligning with MDR/Directives under the EMA, and filing classification requests to PMDA. After classification, we will conduct early regulatory consultations, including FDA pre-submission meetings, EMA scientific advice, and PMDA pre-consultations, which will provide strategic feedback and reduce risks of regulatory delay.

A critical decision point will be data bridging: determining whether Chinese clinical trial data is sufficient for acceptance abroad. If data is accepted, we will perform bridging analyses; if not, we will design and initiate new local clinical trials in each jurisdiction. Following this, formal registration applications will be filed: NDA/BLA or PMA/510(k) in the U.S., CE certification and EMA review in the EU, and NDA or Shonin/Ninsho in Japan.

Simultaneously, Allergone will pursue international manufacturing certifications such as FDA QSR, EU ISO13485, and JP QMS to guarantee compliance with global production standards. Upon securing marketing authorizations in each jurisdiction, we will establish strong local networks through distribution partners, regulatory agents (D-MAH, US Agent), and healthcare collaborations. The global commercial launch will then proceed in a phased manner, prioritizing regions with the highest unmet medical need, supported by educational campaigns for physicians and patient advocacy partnerships to drive adoption.

Beyond the regulatory roadmap, Allergone’s success relies on strategic partnerships. Collaborations with leading hospitals and clinics will accelerate patient recruitment and clinical validation. Partnerships with pharmaceutical companies and biotech incubators will enable scalable production, distribution, and co-development opportunities. Engagement with patient advocacy groups will help Allergone build trust within the allergy community and raise public awareness of immunotherapy as a long-term alternative to symptomatic treatments.

Manufacturing will initially rely on outsourced production through CRO/CMO partners, ensuring cost efficiency during the early commercialization stage. As market demand grows, Allergone will invest in dedicated large-scale manufacturing facilities, establishing long-term production independence and quality assurance.

In the long run, Allergone aims to evolve beyond a single therapy into a comprehensive allergy management platform. This platform will integrate diagnostics, personalized immunotherapy, and digital patient monitoring to create a closed-loop solution for allergy management. By combining scientific innovation, regulatory compliance, and global commercialization, Allergone is positioned to redefine the future of allergy treatment and establish itself as the worldwide leader in next-generation AIT solutions.