ENTREPRENEURSHIP

1A. Background

Helicobacter pylori (Hp for short) is a Gram-negative bacterium that mainly inhabits the stomach and duodenum. It is estimated that about half of the global population is infected with this bacterium. In China, the infection rate is as high as around 50%, and in some rural areas and among adults, it even exceeds 60%. Hp is a major pathogenic factor for gastritis, gastric ulcers, and duodenal ulcers. It has been classified as a Group 1 carcinogen by the World Health Organization (WHO) and is an important cause of gastric cancer.

The transmission routes of Hp include oral-oral transmission, fecal-oral transmission, and cross-infection within families. It is more likely to spread among people with poor hygiene conditions, bad dietary habits, or weakened immune systems. Children, due to their underdeveloped immune systems, are also at a higher risk of infection.

Currently, the "quadruple therapy" (proton pump inhibitor + two antibiotics + bismuth agent) is widely used in clinical practice, with an eradication rate of approximately 80% to 90%. However, its efficacy is facing challenges. On one hand, the rising antibiotic resistance rate leads to repeated infections in some patients. On the other hand, the side effects of the drugs (such as intestinal flora imbalance, nausea, and diarrhea) affect treatment compliance.

Against this backdrop, precise targeted therapy has become a new research direction. Nanotechnology, with its high specific surface area and targeted modification capabilities, is being widely used to enhance drug delivery efficiency, improve antibacterial effects, and reduce systemic toxicity. For instance, nanocarriers can precisely deliver drugs to the infection sites of Hp, and materials like nano-silver have their own antibacterial activities. Some clinical studies have shown that the eradication rate can even exceed 90%. Additionally, probiotic-assisted therapy can improve the intestinal microecology, reduce the side effects of traditional treatment, and enhance patient tolerance.

In summary, under the multiple pressures of high infection rates, increasing antibiotic resistance, and frequent side effects of treatment, new therapeutic approaches with high targeting, high safety, and low resistance risk are urgently needed in the industry. This also provides a realistic basis and development opportunity for the market launch of this product.

1B. Product Introduction

This product is a novel biological agent based on probiotic carrier delivery of nanobodies, designed for targeted elimination of Helicobacter pylori. This approach represents an innovative direction in the field of precision medicine for the treatment of digestive tract infections, aiming to overcome the limitations of current antibiotic therapy through a dual mechanism of "probiotic carrier + antibody drug" to achieve precise clearance of Helicobacter pylori.

1B1. Core Mechanisms

1B1A. Targeted Delivery

By leveraging the natural acid resistance of probiotics, the antibodies are protected from degradation in the gastric environment. Additionally, probiotics have a strong ability to adhere to the gastric mucosa, allowing them to carry antibodies to areas where Helicobacter pylori is densely colonized. This mechanism effectively addresses the issues of degradation and poor targeting in traditional oral medications.

1B1B. Precise Bactericidal Action

The survival of Helicobacter pylori depends on the urease it secretes, which breaks down urea into ammonia to neutralize stomach acid and maintain an alkaline environment. The anti-urease nanobodies we have developed can precisely identify and bind to urease, blocking this process and thereby destroying the alkaline barrier, exposing Helicobacter pylori to the acidic environment and depriving it of its survival conditions.

1B1C. Combined Elimination and Microecological Regulation

After losing its protective mechanism, Helicobacter pylori becomes more susceptible to elimination by antibody-mediated immune responses (such as complement activation and phagocyte aggregation) and synergistic factors. At the same time, probiotics in the stomach can regulate the local microecological balance, alleviating the dysbiosis and inflammatory responses caused by intervention, and enhancing overall gastric health.

This model combines the targeted delivery advantage of the carrier with the high specificity of the antibody, significantly increasing the local drug concentration and reducing systemic side effects, providing a precise solution to the problems of drug resistance and recurrence of Helicobacter pylori. Compared with the bismuth quadruple therapy, this new method can effectively bypass the problem of drug resistance and gradually move towards clinical application, showing a promising therapeutic prospect.

1B2. Product Advantages

1B2A. Overall Advantages

Regarding traditional antibiotic treatment, due to the fluctuating rate of antibiotic resistance, medical practitioners must constantly evaluate treatment plans to ensure their effectiveness. In the current treatment plans, doctors prescribe multiple antibiotics to curb the increase in resistance rates. However, different dosages and durations of medication may also lead to antibiotic resistance, which makes the problem of rising resistance rates inevitable. Our probiotic antibody-targeted therapeutic drug can significantly reduce these side effects. Our drug can change the living environment of Helicobacter pylori by neutralizing urease to inhibit their activity and reproduction. At the same time, probiotics are not only carriers of antibodies but can also serve as live microorganisms that alleviate the side effects of antibiotics. For example, lactobacillus can produce lactic acid to enhance the intestinal mucosal barrier and release anti-inflammatory factors to reduce inflammation and excessive gastric acid secretion.

1B2B. Targeted Therapy

Traditional antibiotics lack selectivity in interfering with the bacterial flora in the stomach. Broad-spectrum killing often damages the beneficial intestinal flora, leading to side effects. However, our product can target the key enzyme that Helicobacter pylori relies on for survival - urease - through nanobody technology. It can directly neutralize its survival mechanism, without interfering with other flora, achieving the treatment of Helicobacter pylori infection and thereby achieving higher treatment safety.

1B2C. Low Side Effects

Traditional treatment methods, especially antibiotic treatment approaches, have problems such as poor drug resistance and significant side effects in some populations. According to an interview with Dr. Li, the director of the Gastroenterology Department of a certain affiliated hospital of Tongji University in Shanghai, the quadruple therapy is not advisable for children, the elderly, or patients with a history of drug allergies. Our developed nano-antibody compound drug is a non-antibiotic biological agent with natural ingredients and extremely low side effects. At the same time, probiotics have also been widely applied in the food and health care fields, and their safety has been verified. Therefore, our plan is particularly suitable for special groups who cannot accept traditional treatment, providing them with a relatively mild and more controllable option.

1B2D. Dual Function

The probiotics we selected not only serve as the carrier for antibody delivery, but also provide additional intestinal protection during the treatment process. They can also offer additional protection to the intestinal tract during the treatment. Probiotics can not only enrich the intestinal flora but also produce organic acids, antimicrobial peptides, and various mechanisms to combat pathogens. This "carrier + regulation" dual mechanism provides patients with a more complete treatment experience, helps repair the gastrointestinal system, and shortens the recovery period.

2A. Market Analysis

2A1. Market for the diagnosis and treatment of Helicobacter pylori

In recent years, the diagnosis and treatment market for Helicobacter pylori (H. pylori) related diseases has shown a stable growth trend, reflecting the importance of this bacterium in the global public health field. According to data from institutions such as Grand View Research and Cognitive Market Research, the global Helicobacter pylori diagnostic market is expected to reach nearly $700 million by 2024 and exceed $960 million by 2030, with an average annual growth rate between 5.8% and 6.5%[ Data Source: https://www.grandviewresearch.com/industry-analysis/helicobacter-pylori-diagnostics-market]. North America, as the main market in this field, accounts for nearly 40% of the global market share, followed by Europe and the Asia Pacific region. The Asia Pacific region, driven by factors such as the gradual improvement of infrastructure and the high incidence of gastric cancer in developing countries, has shown more rapid market expansion potential[ Data Source: https://www.cognitivemarketresearch.com/helicobacter-pylori-diagnostics-market-report].

In addition, the size of the treatment market is more considerable. The global Helicobacter pylori treatment market valuation reached approximately $750 million in 2024 and is projected to grow to nearly $1.2 billion by 2034, with a compound annual growth rate of around 4.7-7%. In terms of treatment methods, the combination of antibiotics and proton pump inhibitors remains the mainstream therapy; however, due to increasing resistance, particularly the widespread tolerance to antibiotics such as clarithromycin and levofloxacin, the treatment failure rate is on the rise. Therefore, many researchers and companies are seeking antibiotic alternatives to reduce the risk of drug resistance and improve treatment success rates.

2A2. Market drivers

Helicobacter pylori is one of the common causes of gastric adenocarcinoma, primary gastric lymphoma, and peptic ulcers. More than half of the global population is affected. Poor hygiene conditions, crowded living environments, and low cleanliness standards are among the reasons for Helicobacter pylori infection. Helicobacter pylori infection can cause duodenal ulcers, gastric ulcers, and other ulcers. A study by the National Institutes of Health in the United States estimates that 90% -100% of duodenal ulcers and 70% -80% of gastric ulcers are caused by Helicobacter pylori infection. In addition, due to Helicobacter pylori infection being one of the main causes of gastric cancer, the World Health Organization has classified it as a Class I carcinogen. Throughout the forecast period, due to the increase in cancer cases, it is expected that the treatment market for Helicobacter pylori will grow at a faster rate.

Besides, the increase in the elderly population drives market growth. Due to the higher susceptibility of elderly people to illness, Helicobacter pylori is believed to be causing an increasing number of infections worldwide. In the next few years, the population aged 65 and above will double. The aging population has increased the risk of chronic diseases such as intravascular diseases, bacterial diseases, and cardiovascular diseases, which means that the world may experience more cases of Helicobacter pylori.

2A3. Market limiting factors

The public's ignorance of Helicobacter pylori infection is constraining the development of the Helicobacter pylori diagnostic market. Due to many people's lack of understanding of the symptoms and consequences of Helicobacter pylori infection, this leads to delays in diagnosis and treatment. One of the reasons for restricting market expansion is the regulatory issues surrounding the authorization of new Helicobacter pylori diagnostic tests. Due to the lengthy and costly regulatory approval process, a novel, innovative diagnostic and testing method for Helicobacter pylori may be more difficult to obtain.

2B. Competitor Analysis

2B1. Macro-environmental Analysis

We use the PESTEL model to conduct macro-environmental analysis.

Political

Firstly, the government has shown strong support for innovative antibiotic alternative treatment methods. This is reflected in the fact that governments around the world are actively adjusting their medical policies and prioritizing the research and development of antibiotic alternative therapies as a key area of support. Especially in developed countries like those in Europe and America, policymakers are more inclined to support innovative treatment plans for common infections such as Helicobacter pylori. For example, the "Breakthrough Therapy Designation" by the FDA in the United States and the "PRIME Program" by the European Union have opened up fast-track approval channels for new antibacterial drugs.

Secondly, governments of various countries have also established corresponding patent protection for nanobody technology. As nanobody technology is a cutting-edge technology in the field of biomedicine, its intellectual property protection is particularly important. Currently, major global pharmaceutical markets have established relatively complete biotechnology patent protection systems, but there are still differences in specific implementation, such as in China, the review standards for gene sequence patents differ slightly from those in Europe and the United States. This requires enterprises to pay special attention and fully improve their global patent layout when conducting such operations.

Finally, international trade policies will have a significant impact on the cross-border circulation of biological therapy preparations (preparations containing live bacteria), such as the cross-border circulation of biological products is subject to very strict supervision. The import requirements for biological therapies vary significantly among different countries. For example, the entry restrictions on genetic engineering products in the Middle East are relatively strict.

Economic

The global budget for gastrointestinal disease treatment is increasing, and it is expected to exceed 80 billion US dollars by 2025. Among this, the investment in innovative therapies targeting Helicobacter pylori is growing significantly. It is notable that the Asia-Pacific region, due to its high infection rate and increased medical expenditures, is becoming the most promising target market. The average research and development cost of nanobody drugs is approximately 2.5-3.5 billion US dollars. Considering the large number of people infected with Helicobacter pylori (about 4.4 billion worldwide) and the serious problem of drug resistance in existing treatment options, the potential market return rate is very promising. Additionally, there are differences in the global healthcare payment systems, and the acceptance of new therapies varies among different countries' healthcare systems. Countries like Germany in Europe have relatively open reimbursement policies for new therapies, while the commercial insurance system in the United States requires more comprehensive cost-benefit data. Different market entry strategies should be formulated for different markets.

Social

The latest research shows that over 65% of patients with Helicobacter pylori prefer "natural" or "microbial balance" treatment options. This proportion is even higher among those under 35 years old. Some patients also prefer natural or oral medication. The aging society has increased the burden of diseases related to Helicobacter pylori infection. Japanese data indicates that the infection rate among people over 70 years old is as high as 70%, and the risk of complications has significantly increased. This provides a clear direction for the development of targeted treatment plans. Regional cultural differences are more pronounced. For example, in East Asia, the acceptance of probiotic foods is high, which lays a good foundation for therapeutic probiotic products. However, in some regions with religious cultural backgrounds, the acceptance of genetically engineered products requires special assessment. Marketing strategies must be adapted to local conditions.

Technological

Firstly, there has been a significant breakthrough in the nanobody technology. The new generation of nanobody engineering platforms have significantly enhanced the targeting ability. For instance, the anti-Helicobacter pylori nanobody developed by the Belgian company Ablynx has a specificity recognition rate of over 95%. However, maintaining stability in the complex gastric environment remains a technical challenge. Another innovation is the delivery system, including breakthroughs in microcapsule technology and pH-sensitive materials, which has increased the survival rate of probiotics in the gastric acid environment from less than 1% to over 30%. The multi-layer encapsulation technology developed by the Israeli company Nutrigen is particularly outstanding. Additionally, in recent years, AI technology has seen significant advancements. AI can assist in research and development, and machine learning algorithms have significantly shortened the time for nanobody screening. The platform of the British company BenevolentAI has compressed the traditional 6-month screening process to just 2 weeks. However, attention should be paid to issues of data quality and algorithm transparency.

Environmental

The carbon footprint in the production of biological drugs has been a topic of great concern. Pharmaceutical giants such as Novartis have committed to achieving carbon neutrality by 2030, which requires a green transformation of the entire supply chain. This includes optimizing fermentation processes, recycling waste, and other aspects. In addition, cold chain logistics is also a challenge, as probiotic products require storage conditions of 2-8℃. The distribution cost in tropical regions may increase by more than 30%. However, emerging freeze-drying technologies and stabilizer research are alleviating this problem.

Legal

From a legal perspective, probiotic carrier nanoantibody products face challenges in terms of regulatory classification. There is controversy over their attribute definition. For instance, they might be classified as biopharmaceuticals, probiotic preparations, or one of the categories within a combined product. Currently, the US FDA tends to manage them as a combined product, which means they need to meet multiple sets of standards simultaneously. Moreover, although ICH is committed to unified standards, there are still differences in requirements among various countries regarding live bacterial preparations. For example, the environmental release requirements for genetically modified microorganisms in the EU are much stricter than those in the US. Globalization strategies must take these differences into account. The potential risks such as microbial translocation and horizontal gene transfer that live bacterial preparations may cause result in significantly higher product liability insurance costs than traditional drugs.

2B2. Micro-environmental analysis

We use Porter's Five Forces Model to conduct micro-environmental analysis

2B3. Competitor identification

We think that competitors fall into two categories: first, traditional antibiotic therapies and drugs, and second, new therapies and drugs other than antibiotics, which are similar to ours. We have identified a representative company for each of these two categories. We will first provide a basic introduction to the core product and product advantages of these two companies, and then compare them with our products based on this.

2B3A. Purmeo

Purmeo is a professional gastrointestinal health brand from Germany. Its core product contains the patented strain Pylopass™ (Lactobacillus reuteri DSM17648). This probiotic helps reduce the Hp load in the stomach by specifically binding to Helicobacter pylori and forming a complex that is naturally excreted from the body. As a food-grade supplement, it avoids the problem of antibiotic resistance and is suitable for daily health care use. However, it needs to be taken continuously for several weeks to show effects and cannot completely replace drug treatment.[ Information Source: https://purmeo.de/pages/faq]

Positioning: Direct competitor (focuses on probiotics for combating Helicobacter pylori).

Core product: Probiotic capsules containing the patented strain Pylopass™ (Lactobacillus reuteri DSM17648), each capsule containing 200 billion bacteria.

Mechanism of action: Pylopass specifically binds to Helicobacter pylori (Hp) and forms a complex that is excreted from the body (non-antibacterial).

Cost and Pricing: Purmeo has a lower production cost (mature probiotic fermentation technology), and holds a patent.

Market Share: European Market: As the origin, Purmeo has a higher market share in Germany and surrounding countries, accounting for approximately 30%-40% of the Hp-related probiotic market (one of the leading brands). Chinese Market: Sold through cross-border e-commerce (Tmall International, JD International), accounting for about 10%-15% of the domestic Hp probiotic niche market (the main competitors are Japanese and Australian brands).

2B3B. Quadruple Therapy (Representative Company: Livzon Pharmaceutical Group)

Quadruple Therapy is the current first-line treatment for eradicating Helicobacter pylori infection, consisting of a combination of proton pump inhibitors, two antibiotics, and bismuth agents. This therapy achieves a 70%-90% eradication rate within 10-14 days through multiple mechanisms such as inhibiting gastric acid, directly killing bacteria, and protecting the gastric mucosa. Although recommended by major guidelines, it has obvious gastrointestinal side effects and an increasingly serious problem of antibiotic resistance, and should be used under strict doctor's supervision.[ Information Source: https://www.livzon.com.cn/]

Positioning: Direct Competitor (Current First-line Treatment for Hp Infection)

Core Components: Proton Pump Inhibitor (PPI, such as Omeprazole) + Two Antibiotics (such as Amoxicillin, Clarithromycin) + Bismuth Agent (such as Calcium Citrate Bismuth).

Mechanism of Action: Antibiotic killing + PPI inhibition of gastric acid + Bismuth agent protection of gastric mucosa.

Cost and Pricing: After hospital markup, the patient pays ¥300-800.

Market Share: Global Hp Treatment Market Share > 80% (dominant position of eradication therapy).

2B4. Competitor analysis overview

3A. Product

3A1. Physical product

Our product is going to be an oral probiotic containing nanobodies which target and neutralize urease produced by the bacteria Helicobacter pylori. The oral probiotic will be in the form of a capsule or pill taken by the patient to treat H. pylori infections, as an alternative to oral antibiotics such as amoxicillin, clarithromycin, and tetracycline.

The antibodies selected for our product are specific to the ureB gene of H. pylori to further reduce possible side effects. However, it is possible that a small proportion of non-harmful bacteria may also be affected.

3A2. Product packaging

Our product packaging comes in two versions: adult version and children's version. The adult version adopts a relatively simple approach. For the children's version, we referred to the view put forward by a director of a pharmaceutical company that there are differences in drug tolerance and demand between children and adults, and designed a version specifically for children.

3B. Price

The price is determined based on the added value of the treatment for patients and healthcare providers. Accordingly, oral nanotechnology drugs provide a potentially more effective and invasive treatment option, which can be priced with traditional treatments. Nevertheless, our prices should remain within the competitive market range.

Prices should be adjusted regularly based on market demand and patients' ability to pay, to ensure the sustainability and accessibility of the treatment. Additionally, coupons or subsidies should be provided to specific patient groups to reduce their financial burden and encourage the use of the treatment. Lastly, we can establish partnerships with healthcare institutions, insurance companies, and government agencies to expand market coverage and provide more support to patients.

3C. Place

3C1. Distribution Channels

We adopt a parallel model of direct sales and distribution.

Among them, direct sales targets consumers directly—through this channel, enterprises can directly control the sales process and provide patients with detailed drug information.

Cooperating with regular distributors through the distributors' channels can effectively cover most of the sellers of medical or health products, such as pharmacies, clinics, hospitals and other sales points, which can effectively increase the market share and popularity of the products.

Considering the specificity of this treatment, partnering with specialty pharmacies that cater to specific patient populations and complex therapies can provide a more focused approach to distribution.

Additionally, we will also use online platforms or dedicated customer service hotlines to market our products and provide services.

3C2. Sales Venues

Since the treatment is targeted at bacterial infections, sales venues should include hospitals and clinics specializing in gastroenterology. These locations are likely to have patients in need of the treatment and healthcare providers who can prescribe it.

Large retail pharmacies that offer consultation services can be effective sales venues. They can provide patients with convenient access to the drug and immediate support from pharmacists.

3D. Promotion

This product implements a dual-track system encompassing both clinical pharmaceuticals and health supplements. The clinical drug promotion strategy establishes a comprehensive "testing-diagnosis-treatment" closed-loop system, supported by the deployment of 13C breath test equipment in medical facilities. For the health supplement market, scenario-specific marketing initiatives include: (1) "Pediatric Infection Prevention Kits" (containing H. pylori test strips and probiotic powder) distributed through maternity and baby stores, and (2) customized "Business Travel Protection Packages" (featuring portable-sized supplements and restaurant safety guidelines) offered through e-commerce platforms.

3E. People

Our team is divided into two core segments: one consists of management personnel, and the other is made up of technical personnel.

Among them，23 technical personnel organized into two specialized groups: the Biology Experiment Group, responsible for nano-antibody engineering and validation, and the Microbiology Group, which focuses on probiotic-pathogen interaction studies and the development of antibiotic alternative solutions, with all members possessing fundamental laboratory skills.

nine management personnel handle offline promotion, and business proposal development.

3F. Process

Our service process involves relatively few steps, which are mainly divided into two categories: one for companies and the other for the general public.

For companies, our main process includes identifying the customer's product demand volume, offering appropriate discounts based on the demand volume, followed by product sales and subsequent after-sales service.

For the general public, the main process consists of customers inquiring about products, and we provide products as well as service.

We have a professional team with extensive knowledge and experience, capable of quickly responding to and resolving problems that customers encounter during the purchasing and subsequent after-sales processes.

3G. Physical Evidence

Our physical evidence fall into two categories, one for companies and the other placed in pharmacies for the general public.

The evidence for companies mainly include a dedicated exhibition area provided by our company. Aligned with the product positioning, visually, it showcases our different product packages.And it features a comfortable and elegant fragrance formulated by a perfumer. Last, employees' uniforms match the colors of our product packages.

As for the evidence in pharmacies, a special rectangular display rack is set up. Each rack has two tiers, holding our two different product packages respectively. Next to each rack, there is a promotional staff member, whose uniform's color is consistent with that of our product packages.

4A. Strategy

Our business plan is divided into three stages. The first stage is the research and development experimentation stage. After entering the second and third phases of clinical trials and accumulating sufficient clinical data, we will prepare for the market access approval for the product. Once the product enters the market, the company will adopt corresponding distribution methods to expand the market share of the product, such as online stores, offline pharmacies, individual sales; self-recommendation to hospitals, establishing long-term cooperation with major authoritative hospitals across the country, and conducting popularization of nanobody therapy. It is expected that after the company achieves profitability in the third year, it plans to establish a branch in China and establish a more stable and large-scale cooperation with transportation companies to reduce logistics costs. At the same time, when the company's development is stable, such as entering the medical insurance directory and accounting for 15% of the sales volume in the drug type for treating Helicobacter pylori, the company plans to establish the company and factory overseas to expand the overseas market.

The company plans to allocate a portion of the funds to fulfill CSR. The company will conduct public awareness campaigns on hp, popularize the prevention knowledge of hp, as well as synthetic biology knowledge.

4B. Milestone

2028: The factory achieves profitability

The plan for 2028 is for both the factory and each quarter to achieve profitability and have funds flowing back. The market share of the core products will increase, and the internal system of the company will also be improved.

2029: Prepare for expansion or establishment of a new factory

In 2029, plans are made to prepare for the expansion or establishment of a new factory. Financially, it is intended to secure approximately 70% of the total investment through attracting investors, financing, or government grants. At the same time, the factory's equipment, personnel, and capital requirements need to be planned, and the site selection and registration of the branch company should be completed.

2031: Expand the factory

In 2031, it is planned to start expanding the existing factory or building a new one. The 10,000-square-meter factory building in Hangzhou Linping Donghu Elevated Road will be leased (2.19 million per year), and equipment purchase or lease contracts with suppliers will be signed. At the same time, a production capacity plan will be formulated to cover the potential markets across the country, and the market forecast report for the next three years and the feasibility assessment of the new factory will be completed.

2032: Factory Acceptance and Trial Operation

In 2032, the factory acceptance and trial operation are planned. This includes equipment delivery and installation, equipment commissioning and trial production to ensure safety and reliability. At the same time, local pharmaceutical experts and fresh graduates will be recruited and trained. After all tests are completed, the factory will officially start production and develop the local market.

2038: Expanding into Overseas Markets

Starting in 2038, we will begin to establish a presence in overseas markets. We need to conduct in-depth market research in regions with a high incidence of Helicobacter pylori, such as Southeast Asia, Europe, South America, and North America. We must understand the local politics, consumption habits, and competitors.

We plan to conduct in-depth market research in regions with a high incidence of Helicobacter pylori, such as Southeast Asia, Europe, South America, and North America at that time. We need to understand the local politics, consumption habits, and competitors. We will also prepare to get the product certification of probiotic nano-antibodies in overseas markets, such as (EU CE, US FDA), to meet the entry standards of the target market.

2039: Overseas Localization Preparation

In 2039, overseas localization preparations will be carried out, including selecting multiple factory construction sites in the target area, recruiting local legal, sales, and supply chain core personnel, and increasing the proportion of overseas market exports to 10%-20% of the total production to test market potential.

2040: Establishment of Overseas Factories

In 2040, overseas factories will be established. Construction of the overseas factories will be carried out, and local bidding will be conducted to open up the bidding process. Company accounts will be opened in banks such as HSBC and Standard Chartered in Hong Kong to ensure the return of funds to the parent company.

2042: Overseas factory construction completed

In 2042, the overseas factory was completed. Then, local recruitment and training of employees and experts were carried out. After the analysis of the trial production results, it was put into formal operation.

4C. Forecast Income and Cost

4C1. Income

Firstly, in terms of pricing strategy, since we have referred to the most mature quadruple therapy available in the market (with an ideal cost of approximately 372 yuan), and combined with the technological added value of the product and the prediction of the target customer's payment capacity, the product price has been set at 400 yuan per box. Based on the expected annual sales of 15,000 boxes, the annual revenue can reach 6 million yuan, and it is expected to achieve break-even in the second year and turn losses into profits in the third year.

4C1. Cost

In terms of costs, we have divided the cost structure into three categories: long-term fixed costs, annual fixed costs, and unit variable costs.

Long-term fixed costs

Firstly, long-term fixed costs mainly involve building a basic pilot-scale production line. All equipment is designed for the preparation of antibodies and the processing of probiotic carriers, including freeze centrifuges, liquid chromatographs, ceramic membrane filters, small fermentation tanks, freeze dryers, and capsule filling equipment. The total investment is 966,600 yuan. In equipment selection, we have prioritized small size, scalability, and adaptation to the initial production capacity. The purchase quotations come from Alibaba and professional scientific research equipment platforms, with public, transparent, and reasonable market basis.

Annual fixed costs

Annual fixed costs are mainly human resources and energy. Based on the average annual salary of private sector employed personnel in Sichuan Province in 2024 (average 5,263.4 yuan), we estimate an average monthly salary of 5,000 yuan, and the team initially plans to hire 30 people. Therefore, the annual labor cost is 1.8 million yuan. At the same time, the expenses for water, electricity, and plant operation and maintenance are expected to be around 300,000 yuan.

Variable costs

After the product is officially put into production, variable costs will become a key expense in the enterprise's continuous operation. These costs mainly consist of antibody raw materials, probiotic powder, packaging materials, and logistics transportation, and will increase year by year with the growth in sales volume.

The cost of antibody raw materials is the most core item. According to the product formula, each tablet contains 100 micrograms of nanobody, and 14 tablets constitute one course. We refer to the prices of currently available antibody drugs on the market to determine that the cost of antibodies per box is approximately 110 yuan. Due to the high technical threshold of antibody production and the large price volatility, we plan to establish a long-term stable cooperative relationship with upstream biotechnology companies to lock in prices in advance while ensuring quality, thereby controlling the risks brought by cost fluctuations.

Probiotics, as the carrier of the drug, have relatively stable powder costs. We expect each tablet to contain 1 gram of probiotic powder. Based on the current market price of 350 yuan per kilogram, the cost of each box is approximately 5 yuan. Probiotics are a general-purpose biological raw material with sufficient supply and large bargaining space, and this cost has good controllability.

In terms of packaging materials, we select standard aluminum-plastic blister packaging and paper outer boxes, with the cost of each box controlled within two yuan. We will choose a universal packaging scheme to adapt to automated equipment and increase the purchase batch size, thereby further reducing the unit cost.

The logistics transportation cost is expected to be less than 1 yuan per box in the initial stage, mainly including cardboard costs and express fees. Through centralized packaging transportation and signing agreements with third-party logistics companies, this expense can be effectively controlled. As the sales scale expands, we also consider establishing regional warehousing nodes to further reduce the unit cost of transportation.

Based on the minimum batch calculation, the total production and delivery cost of each box of the product is approximately 117 yuan. With annual sales of 15,000 boxes, the total annual variable cost is approximately 1.75 million yuan. This part of the expenditure will mainly rely on sales revenue to support, that is, the cash flow generated by the sale of the product will directly cover the funds required for production materials, packaging, and transportation.

Profit

By calculating the three types of costs in total, in the first year, due to equipment investment and the pressure of early promotion, the overall expected loss is approximately 870,000 yuan. But starting from the second year, it will achieve break-even, and from the third year, it will enter a stable profit stage. According to the current model calculation, the annual profit in the fifth year can reach over 3.2 million yuan.

Given that the initial sales have not yet resulted in stable cash collection, we have also designed a plan to alleviate the cash pressure in advance. For instance, we have negotiated with antibody suppliers and probiotic manufacturers to extend the payment period to 30 to 60 days, thereby reducing the capital occupation for the first batch of purchases. We will also carry out market preheating and pre-sale planning in advance, especially through online channels or cooperation with medical institutions, to secure some of the first batch of orders to obtain advance payment to support the initial production. Additionally, we will also exchange promotion resources or cash flow through channel joint marketing to reduce the financial pressure in the early stage of market expansion.

The project's execution is driven by a specialized team with clearly defined roles. Wu Yuecong, Xie Jiazhao, Wang Miaolin, and Li Changjie lead product research, conducting market analysis and compiling data on competing technologies globally. Zhang Shiqi, Wang Yisen, and Guo Shize focus on market demand assessment, refining product positioning and identifying key market segments. Zhang Zilin and Yuan Jiaqi oversee marketing strategy, laying the groundwork for clinical trials and commercialization. Additionally, a dedicated R&D team of 23 members advances the technical development of the project. This collaborative structure ensures a seamless transition from innovation to market-ready solutions.

[1]Li, Y., Choi, H., Leung, K., Jiang, F., Graham, D. Y., & Leung, W. K. (2023). Global prevalence of Helicobacter pylori infection between 1980 and 2022: a systematic review and meta-analysis. The lancet Gastroenterology & hepatology, 8(6), 553-564.

https://www.thelancet.com/journals/langas/article/PIIS2468-1253(23)00070-5/abstract

[2]Liu, L., Guo, Y., Wang, B., Pan, Y., Zhao, C., Xiao, Z., ... & Rao, L. (2025). Yogurt-inspired hybrid membrane vesicles for the prevention and treatment of Helicobacter pylori infection. Cell Biomaterials, 1(4).

[3]Microbiome Therapeutics Innovation Group, & Barberio, D. (2024). Navigating regulatory and analytical challenges in live biotherapeutic product development and manufacturing. Frontiers in Microbiomes, 3, 1441290.

https://www.frontiersin.org/journals/microbiomes/articles/10.3389/frmbi.2024.1441290/full

[4]Roberts, L. T., Issa, P. P., Sinnathamby, E. S., Granier, M., Mayeux, H., Eubanks, T. N., ... & Kaye, A. D. (2022). Helicobacter pylori: a review of current treatment options in clinical practice. Life, 12(12), 2038.

https://pmc.ncbi.nlm.nih.gov/articles/PMC9785457/#sec7-life-12-02038

[5]Wang, L., Li, Z., Tay, C. Y., Marshall, B. J., Gu, B., Tian, Y., ... & Zhou, B. (2024). Multicentre, cross-sectional surveillance of Helicobacter pylori prevalence and antibiotic resistance to clarithromycin and levofloxacin in urban China using the string test coupled with quantitative PCR. The Lancet Microbe, 5(6), e512-e513.

https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(24)00027-2/fulltext

[6]Wuzhou Medical Association. (2023). Chinese guidelines for the treatment of Helicobacter pylori infection. http://wuzhoumed.com/uploadfiles/2023/08/20230828174714644.pdf

[7]Yang, Y.-J., Chen, P.-C., Lai, F.-P., Tsai, P.-J., & Sheu, B.-S. (2020). Yang, Y. J., Chen, P. C., Lai, F. P., Tsai, P. J., & Sheu, B. S. (2020). Probiotics-containing yogurt ingestion and H. pylori eradication can restore fecal Faecalibacterium prausnitzii dysbiosis in H. pylori-infected children. Biomedicines, 8(6), 146.

https://pmc.ncbi.nlm.nih.gov/articles/PMC7344718/

[8]Yang, Z., Zhou, Y., Han, Z., He, K., Zhang, Y., Wu, D., & Chen, H. (2024). The effects of probiotics supplementation on Helicobacter pylori standard treatment: an umbrella review of systematic reviews with meta-analyses. Scientific Reports, 14(1), 10069.

https://www.nature.com/articles/s41598-024-59399-4