Now，cancer has become a global public health problem. But currently, the production of existing antibody drugs for cancer treatment is often costly, involves multiple steps, and has many problems such as low expression levels and poor stability. In addition, most existing production platforms rely on chemical inducers, which are likely to affect the purity of the product and the production environment, making it difficult to meet the safety and efficacy requirements for clinical applications. Therefore, building a safe, controllable and efficient antibody production system is of great significance for advancing the research and development of cancer treatment drugs.

Our project established an efficient and controllable nanobody production platform by leveraging the red-light-induced gene expression system of Escherichia coli. The application of red-light-induced gene regulation technology, along with the protein production function of Escherichia coli, enables precise control of nanobody expression during the preparation of antibody drugs. The system will use non-invasive red light pulses for real-time control, thereby reducing side effects and energy consumption in the production process and significantly improving the efficiency and quality of nanobody preparation.

In addition, our project is mainly focused on the "Red light-induced nanobody production system," with the aim of breaking through the research and development bottleneck of antibody drugs. Based on previous cross-innovation between light control technology and biomedicine, we aim to build an intelligent production system and precisely address the pain points of traditional antibody production, such as low efficiency, high cost, and environmental pollution.

Industry analysis mainly uses PEST models. In the process of development, different industries are in different political, economic, social and technological environments. Therefore, when conducting industry analysis, it is important to note that each industry has its own macro environment. For every industry, the role of political and economic factors in its development cannot be underestimated, and social and technological factors can also have a significant impact on its development.

P: Policy support for nanobody drugs and red light technology

In recent years, the state has focused on the innovative development situation in the field of biomedicine and has successively introduced a series of relevant policies to vigorously encourage the research and development of nanobody drugs, and has also included the cross-innovation of light control technology with biomedicine in the scope of key support directions. Take the "14th Five-Year Plan for the Development of the Pharmaceutical Industry" for example. It clearly stipulates that corresponding support should be given to precision treatment technologies and the construction of new production systems, so that innovative achievements such as the red light-induced nanobody production system can be smoothly transformed and truly take root in the industry. A series of policy guarantees, such as green channels for approval and special subsidies, will be provided to enable the related technologies to move from the laboratory stage to the clinical application stage more quickly.

E: The economic environment drives development

The growth rate of the Chinese economy has remained stable, indicating that the overall economic environment is relatively good. Residents' income levels have risen, and their consumption capacity has increased accordingly. As a result, there has been an increase in demand for high-quality medical services and new biopharmaceuticals, which has driven the demand for nanobody drugs and contributed to the development of the red-light-induced nanobody industry. The economic growth has also prompted governments and businesses to increase their investment in the field of scientific and technological innovation, thereby providing more financial support for the research and development of nanobody technology.

In addition, interest rates are relatively low, which reduces the cost of financing for businesses. For nanobody technology companies, it is easier to obtain loans in this case. They can use the loans to carry out research and development work, advance production activities and expand markets, thereby promoting technological innovation and industrial upgrading.

S: Social demands give rise to opportunities

The aging population is growing worldwide, and the incidence of diseases like cancer is on the rise; At the same time, irregular lifestyles and increased mental stress have led to a younger onset of cancer.

Compared with traditional chemotherapy, antibody drugs have certain advantages. They may reduce the side effects of treatment, benefit patients' lives, and thereby improve the quality of life of patients. As a result, the demand for drugs, especially for new nanobody drugs, has gradually increased.

In addition, as people's quality of life has gradually improved, health awareness has also gradually increased, and patients' acceptance of new drugs has gradually increased, which is conducive to the promotion of new drugs.

T: Technological development trends

Red light-induced technology has seen rapid development in the field of biomedicine in recent years. The development path is from research on basic optogenetic mechanisms to the transformation towards clinical application. At the level of gene regulation, it is now possible to precisely activate specific gene expression pathways with the help of red light, thereby controlling the timing and yield of nanobody synthesis.

In terms of Market analysis, we use Porter's Five Forces model.

1. The intensity of competition from existing competitors

There is intense competition within the industry at the moment. Blue light therapy is more mature in vitro studies or superficial treatments, such as Shanghai Guangsheng Pharmaceutical Company, which has taken the lead. In contrast, the competition in the blue light field is more intense for us. Moreover, red light therapy is still a long way from actual clinical application, and the professor we visited mentioned that there are still many technical and ethical issues to be addressed, so the overall competition is strong.

2. The threat of potential entrants

The threat from potential entrants is weaker. Potential entrants are currently less capable of entering the market because the current nanomedicine therapy market is relatively new and the drug research cycle is long, often taking more than a decade from patent application to clinical research and then to commercialization of the drug. As a result, it is difficult for drugs to enter the market, and the industry barriers are high, making it hard for other companies to enter the market.

3. The threat of substitutes

The threat of substitutes is stronger. Mature technologies such as traditional antibody drugs, small molecule inhibitors, and CAR-T cell therapies may be more clinically acceptable; If other light-controlled technologies are more efficient, they may replace red light-induced regimens.

4 The bargaining power of suppliers

The supplier has strong bargaining power. Because there are few manufacturers of customized red light emission equipment, the bargaining power is strong.

5. The bargaining power of the purchaser

The bargaining power of the buyer is moderate. Our products are ahead of most existing technologies, but not yet fully mature, so there will still be a large number of buyers with bargaining power. But the overall bargaining power of this group of buyers is moderate, because once they fall ill, drug treatment is necessary unless they give up treatment, so overall the bargaining power of this group of buyers is moderate.

The global competition for anti-tumor drugs is intense, and anti-tumor drugs with the same target as our nanobodies developed from kits are dominated by several large pharmaceutical companies. Here are some of the main competing products:

Figure 1: competing products

It can be seen that our competitors, although targeting the same target, have a more diverse range of treatable cancer types. Therefore, after comparison, our product should seek more diverse measures to deal with cancer, such as expanding the product line after the product production stabilizes.

In order to better improve our marketing strategy, the SWOT analysis model is mainly used here to summarize the various factors that affect our company and analyze our company's strengths, weaknesses, opportunities and threats.

S: For our product, the strength lies in innovation, as there were no nanobodies produced using red light induction before. The use of red light induction, first, can significantly reduce side effects and energy consumption in the production process, improve antibody expression efficiency, and the good scalability of the production system can also be used in the production of other biopharmaceuticals. Second, red light has less impact on the production status of the bacteria than blue light.

W: The weakness of our product lies in the long conversion cycle, the high clinical threshold and the potential negative impact on people and the environment, so it will take time to complete the research and bring it to market. And for people, drug resistance is an important issue, which may pose some threats to human health. For the environment, the metabolic capacity of our product needs to be considered because its technology may make it difficult to metabolize and have some impact on the environment.

O: In terms of opportunities, at the macro level, national policies are strongly supporting precision medicine and biotechnological innovation, and the "14th Five-Year Plan for the Development of the Pharmaceutical Industry" explicitly states that key technological directions such as "light-controlled drug delivery" should be broken through. And the red light market has great potential for development because it is currently in the innovation stage, and previously only blue light-induced nanobodies have been used for light system induction. Red light has not yet entered the clinical stage and is still under study, with great prospects.

At the micro level, as residents' living standards continue to rise, the acceptance of new treatment methods is increasing; In order to provide better treatment options for patients, various countries facilitate the listing of innovative drug companies, while domestically encouraging innovative drugs to be included in medical insurance at reduced prices, providing new treatment options for more people.

T: At present, there are numerous biotech companies, and many of them are researching light-induced technology to produce antibodies. Therefore, with a large number of external competitors, the external threat has increased.

From the SWOT analysis, it can be seen that our business plan has both strengths and opportunities as well as weaknesses and threats. In general, opportunities and challenges coexist. So we need to speed up, experiment and develop, test and verify, promote, and find our place in the industry prospects where opportunities and challenges coexist.

3.1.1 Product entity

The product is mainly composed of three main parts: the first part is the red-light-induced nanobody expression system. The product is based on an advanced Escherichia coli expression platform. Combining carefully selected nanobody genes with photosensitive proteins and irradiating them with red light of specific wavelengths can effectively induce the expression and secretion of the nanobodies, achieving precise regulation of antibody production; The second part is a wavelength-tunable portable red light control device. It has a flexible wavelength adjustment function to meet the specific requirements for red light wavelengths in different experimental and therapeutic scenarios. Here is our product display.

Figure 2 :Product entity

3.1.2 Product packaging

Our packaging is currently set up as a small box with our project logo printed on it, as shown in the picture.

Figure 3 :Product packaging

3.1.3 Products and Services

(1) Technical support services

Build a professional technical team. Provide customers with 24-hour online technical consultation. Provide customers with all-round assistance, from product usage training, experimental scheme design to problem-solving.

(2) After-sales support service

Build a professional after-sales service team. Implement quality assurance services and provide on-site repair services once there is a quality problem with the product.

We have two product lines: One follows a high-end customized route, and the other follows a universal route. The pricing takes into account production costs (including raw materials, equipment, personnel salaries, etc.). We recommend a price range of 500 to 800 RMB for the universal route, and 3,000 to 4,000 RMB for the high-end customized route. The specific pricing strategy is as follows.

The raw material cost for the universal kit is 250 RMB per unit. This cost mainly includes: 200 RMB for the red light lamp, 20 RMB for the buffer solution, strains replicated using a shaker (price is negligible), and other raw materials totaling 250 RMB. Therefore, we price our product at 600 RMB.

The raw material cost for the high-end customized product is 2,500 RMB. This cost mainly includes 200 RMB for the red light lamp, 20 RMB for the buffer solution, 1,000 RMB for the customized strain, 1,000 RMB for the raw materials required to produce the strain, and other minor raw materials totaling 2,500 RMB. Therefore, we price our product at 3,500 RMB.

3.3.1 Distribution Channels

Focus on the characteristics of the red-light-induced nanobody products and work deeply with professional pharmaceutical distribution platforms, leveraging their channel networks covering top-tier hospitals and specialized oncology hospitals across the country to quickly reach medical institution customers.

3.3.2 Sales locations

Set up brand experience centers in cities where the biopharmaceutical industry is concentrated, such as Shanghai, Beijing, and Guangzhou, equipped with real-time demonstration devices of red-light-induced nanobodies, and invite personnel from hospital pathology departments and R&D departments of pharmaceutical companies to experience on-site to facilitate cooperation. Establish long-term residency relationships with shared laboratories of universities and research institutions, set up product trial points, and make it convenient for researchers to access and test at any time.

For universities and research institutions, we offer customized packages for the experimental cycle. If you purchase a full-year (estimated based on the frequency of experiments) red light-induced nanobody production system, you can enjoy a 20% discount. In collaboration with biopharmaceutical incubators, we offer half-price first order plus free preclinical trial protocol consultation services to start-up companies that have settled in, to help them quickly develop drugs and lock in future long-term partners.

We are a biotech startup team, and we are mainly divided into two small teams, one responsible for contact laboratory reagents and research and development, and the other for non-contact laboratory reagents, mainly responsible for pre-planning and post-product. Everyone has a clear division of labor and is responsible for different tasks. Both teams have their own leaders and managers, and there are leaders as big managers to ensure the smooth operation of all parts of the company. The R&D team, which focuses on lab research and technical content, is at the core of our technology. The market research team is mainly responsible for collecting and interviewing relevant information and feedback, industry status and competitor information to ensure that our product direction is in line with actual needs. Our products are mainly targeted at pharmaceutical companies, hoping to provide them with more precise and efficient options for producing antibodies through technological innovation.

If a customer comes to consult, we first conduct a technical assessment, evaluate the customer's needs, and develop either a universal solution or a customized solution, then proceed to the production and after-sales stages. This is a complete process.

On the one hand, we will showcase our products at the exhibition, and on the other hand, we will cooperate with downstream manufacturers to display our products.

At the exhibition, we plan to set up a double-layer display stand with a custom radioactive red light pattern. The stand will showcase our two products respectively, and the staff beside it will be dressed in red uniforms to match the theme of our products.

In the offices of our downstream partner companies, we plan to maintain the same display style as at the exhibition.

Our key partners cover multiple aspects: the upstream includes suppliers; the downstream comprises nanobody-producing companies and brand promotion companies; in addition, they also include regulatory authorities that issue licenses, distributors, online sales platforms, online promotion platforms, exhibition partners, and venture capital firms.

Key activities are mainly divided into the pre-launch phase and the mid-development phase. Among which, the pre-launch phase requires completing the work of obtaining a production license and securing initial investment; while in the mid-development phase, it is necessary to launch marketing campaigns and establish cooperative connections with exhibitions and manufacturers.

Key resources include physical resources, which mainly cover laboratories, factory land and equipment.

Our value proposition is mainly embodied in producing kits capable of generating nanobodies for the society, and these kits have the product advantages of high efficiency and controllability.

In terms of customer relationships, we establish in-depth partnerships with biopharmaceutical companies and conduct collaborative innovation with research institutions.

The channels include industry exhibitions and summits, cooperation with industry media, owned media platforms and official corporate websites, as well as channels related to research institutions.

Customer segments include research institutions and biopharmaceutical companies.

The cost structure includes start - up costs in start - up capital, fixed costs (involving equipment, factory, office rent, annual energy expenses, and annual promotional expenses), as well as variable costs (covering raw material costs, supply chain costs, workers' salaries, technicians' salaries, and managers' salaries).

In terms of revenue streams, revenue is generated in the short term by selling universal antibody kits, and in the long term by selling both universal antibody kits and high - end customized kits.

a.0-1 Year

Determine the factory site and office location, purchase factory premises, rent offices, and buy laboratory equipment;

Register the company and obtain licenses and permits;

Make preparations before conducting research and purchase laboratory supplies.

Form a team consisting of 14 management personnel and 44 technical personnel.

b. 2-4 Years

Product testing and certification to confirm the safety and effectiveness of our products；

Build brand image, develop a business website, establish a social media presence, and issue press releases；

c. 5-6 Years

Promote our products and explore marketing channels, including social media and promotions；

Sell products through multiple channels, with the universal line priced at 600 yuan and the high-end product line priced at 3,500 yuan.

Tracking and analysis. Monitor indicators such as costs, revenue, profit, and customer satisfaction, analyze the data, provide results, and feed them back into the production process of subsequent projects for implementation.

The following are the equipment we need and their prices.

Figure 4 equipment

But we need not only equipment, but also land and factories. Therefore, we have compiled all the initial funds we require.

At the same time, since our product R&D and validation period will last four years, we will need 10 R&D experts during this period, each with a monthly salary of 12,000 RMB and an annual salary growth rate of 8%.

Therefore, our initial investment is approximately 8681301 RMB.

Figure 5 cost of project

Starting from the fifth year, after a series of market validations, we will begin producing our products. Therefore, this will be our first year of production, Our subsequent financial forecasting will also be recorded from the first year.

4.4.1 Cost

Since we have two production lines, with products divided into a universal version and a high-end customized version, our total cost will be evenly allocated to each production line, that means, the cost for each line will be half of the total cost.

(1) Long-term fixed costs

Our fixed costs include the factory and equipment, which is the total initial investment cost of 2,192,500 yuan calculated in the start-up capital section. Therefore, the long-term fixed cost for each production line is 1,096,250 yuan.

(2) Annual fixed costs

Annual fixed costs include office rent, annual energy expenses, and annual promotional expenses. Moreover, the annual fixed costs for both production lines are the same.

Figure 6 Annual fixed costs

(3) Annual variable costs

Annual variable costs include raw material costs, supply chain costs, worker salaries, technician salaries, and management salaries.

Among these, The raw material cost for the universal line is 250 yuan, and the raw material cost for the high-end customized line is 2,500 yuan. In the third, fourth, and fifth year, due to increased production volume and larger purchases of raw materials, the prices may decrease, so we have set them at 200 yuan and 2,000 yuan respectively. The total raw material cost is the unit raw material cost multiplied by the sales volume for the year.

Since the products require refrigeration during transportation, the unit supply chain cost is 5 yuan. The total supply chain cost is the unit supply chain cost multiplied by the sales volume for the year.

Salaries are divided into three categories: worker salaries, technician salaries, and management salaries.

The monthly salary for each worker is 5,000 yuan, and there are 30 workers in total, so the annual worker salary is 5,000 × 30 × 12. In the third year, as sales increase, our number of workers will rise to 35, and in the fifth year, it will increase to 40. At the same time, since we have two production lines sharing the same workforce, the figure for each production line is half of the total salary.

The monthly salary for technicians is 12,000 yuan, with 21 internal technicians and 23 externally hired technicians, resulting in an initial annual total technician salary of 6.336 million yuan. Again, since both production lines share the same technical personnel, the figure for each line is half of the total salary, and technician salaries increase by 8% annually.

The monthly salary for managers is 14,000 yuan, with 14 managers in total, resulting in an initial annual total management salary of 2.352 million yuan. Similarly, since both production lines share the same management team, the figure for each line is half of the total salary, and management salaries increase by 5% annually.

In addition, all data are presented without decimal places.The following is a detailed data presentation.

Figure 7 universal line

Figure 8 high-end customized line

4.4.2 Income

We consulted existing biotechnology companies in the market and found that their sales volume growth rate at the start-up stage was 65%. Taking into account the industry conditions and our company's actual situation, we predict that the sales growth rate will change each year. Using a five-year financial forecast as an example, the sales growth rate will increase year by year. With the selling prices remaining stable at 600 yuan and 3,500 yuan, the revenue side is expected to achieve sustained high growth. Therefore, in the end, as sales volume increases rapidly and the cost structure is further optimized, revenue will gradually increase.

Figure 9 universal line

Figure 10 high-end customized line

4.4.3 Profit

Profit is calculated as sales revenue minus total cost, where total cost is the sum of all costs. As shown in the table, over time, the profit gradually changes from negative to positive, and a stable positive cash flow is achieved.

Figure 11 universal line

Figure 12 high-end customized line

6.1.1 competitive risk

new entrants may bring price impacts, squeezing the profit margins of existing enterprises. In addition, existing enterprises continue to expand to compete for market share, which further intensifies competition and increases the risk of market share fluctuations. Enterprises need to continuously enhance their own competitiveness to cope with competitive pressures.

6.1.2 Measures

We will strive to reduce costs, build brand advantages, and strive to make our products gain cost-performance advantages, so that they can stand out among numerous enterprises.

6.2.1 logistics risk

E. coli is relatively sensitive to environmental factors such as temperature and vibration. If temperature control fails during transportation, it may cause the strain to become inactive, affecting subsequent experiments or production; severe vibration may damage the bacterial structure, leading to cell lysis and loss of usability. Therefore, we face many risks during the transportation process.

6.2.2 Measures

We have decided to use cold chain transportation or add ice during shipment to preserve freshness and reduce the risk of high temperatures; in addition, during transportation, we will use multiple foam pads to prevent our products from being damaged by bumps.

We divide our team members into two parts, the management team and the technical staff. Among them, there are 14 main members of the management team and 44 technical personnel.

14 managers will be responsible for background checks, organizing current problems, providing solutions to current problems, conducting market analysis and competitive analysis, marketing promotion, and financial forecasting sections; 44 technicians are responsible for research and development.