1. Project Overview
The project is located in the Lucheng Industrial Zone of Huangcun Town, Daxing District, Beijing (east to Xinhang Street, west to Planning Road, south to Efang South Road, and north to Chuangye Road). The total land area of the site is 7,054.33 square meters, and the total construction area of the project is 18,581.50 square meters, including a research and development center building of 1,584.00 square meters. The main new construction facilities of the project include an instrument building, a reagent building, and underground works.
The construction period of the project is 36 months, with a total investment of 441.8081 million yuan, of which the construction investment is 399.7995 million yuan, and the working capital is 42.0086 million yuan.
The products produced by this project include a series of pathogen detection reagents and supporting instruments based on colloidal gold and chemiluminescence methodologies. After reaching production capacity,
Beijing Beier Bioengineering Co., Ltd. will increase investment in the construction of a chemiluminescence reagent product line while consolidating its traditional colloidal gold reagent base. In the field of pathogen detection, the company will strengthen the development of traditional advantageous products such as respiratory series and preconception care series, while simultaneously expanding into high-value new business areas such as thyroid hormone detection and tumor marker detection, building a diversified product portfolio.
In the field of detection equipment, the company will accelerate the industrialization process of the BR-2000 series fully automated chemiluminescence analyzers to achieve a business closed loop of “equipment + reagents,” enhancing the overall solution capability of the diagnostic system. After reaching production capacity, the company is expected to open up broader market space, expand new performance growth points, and enhance the company’s overall competitive advantage.
Beijing Beier Bioengineering Co., Ltd. is a national-level specialized and innovative “little giant” enterprise engaged in the research, development, production, and sales of in vitro diagnostic reagents and supporting instruments. Since its establishment, the company has adhered to independent research and development, viewing technological innovation as the primary driving force for enterprise development. After years of independent research and technological accumulation, it now possesses platforms for enzyme-linked immunoassay reagents, POCT rapid diagnostic reagents, magnetic microparticle chemiluminescence diagnostic reagents, diagnostic instruments, and biomaterials, establishing a complete industrial chain of reagents, instruments, quality control products, and consumables, providing comprehensive testing solutions for clinical laboratories. The company’s products primarily focus on respiratory pathogen detection, covering multiple testing fields such as preconception care, hepatitis, EB virus, and autoimmune antibodies, achieving coverage of all application scenarios from professional laboratories to grassroots medical institutions.
The company insists on deepening its focus on key diagnostic fields, continuously enhancing the depth and breadth of its product series development strategy, and has formed more than ten product lines, including respiratory pathogen series, preconception care series, hepatitis virus series, EB virus series, autoimmune antibody series, thyroid function series, sex hormone series, tumor marker series, cardiovascular series, and hypertension series, covering multiple testing fields, making it one of the enterprises with the richest series of immunodiagnostic products.
As of April 30, 2025, the company has obtained 459 domestic medical device registration certificates/filing certificates, including 168 Class III medical device registrations, 239 Class II medical device registrations, and 52 Class I medical device filing certificates, and has independently developed and obtained 37 software copyrights, achieving a multi-methodology and multi-product layout in the field of immunodiagnostics. After years of market development and cultivation, the company has accumulated numerous high-quality customer resources in the domestic market with excellent and stable product quality, entering the supply systems of many large well-known enterprises, well-known third-party testing institutions, and leading hospitals nationwide, with a good brand reputation and recognition.
The company is one of the earliest enterprises to layout respiratory pathogen detection reagents in China, with a solid technical foundation and a high market position. Based on the requirements of undertaking the national “Twelfth Five-Year” major science and technology project, the company began researching respiratory pathogen diagnostic reagents in 2012 and continuously iterated its technology platform, establishing products based on enzyme-linked immunoassay, colloidal gold method, and magnetic microparticle chemiluminescence method, suitable for different application scenarios, effectively meeting the needs of different customers.
Currently, the respiratory product line developed by the company is the most comprehensive series of respiratory pathogen detection products in China, effectively identifying respiratory pathogen infection conditions, providing detection tools for terminal medical institutions, serving as an important basis for clinical treatment plans, preventing unreasonable use of antibiotics, and effectively reducing patients’ medical costs.
In the field of preconception care testing, the company actively responds to the national birth defect intervention project and has developed the TORCH series product line, one of the earliest product lines launched in China, covering five major pathogens for preconception care testing. The product quality has achieved a 100% pass rate in national inter-laboratory quality assessments for many years, ranking among the top in the domestic market share. The company’s preconception care series product line has been on the market for 20 years and has gained long-term trust from numerous customers. In the field of hepatitis testing, the company is one of the most complete manufacturers of viral hepatitis testing reagent product lines in China.
In 2007, the company’s hepatitis E IgM antibody testing reagent (enzyme-linked immunoassay) obtained drug registration number, and in 2009, it was one of the earliest to obtain registration numbers for HDVAg, HDVIgG, and HDVIgM testing reagents. In recent years, the company has continuously innovated and iterated its technology platform, and has now launched a product system for detecting viral hepatitis and autoimmune hepatitis markers based on enzyme-linked immunoassay, colloidal gold method, and magnetic microparticle chemiluminescence method, among which the magnetic microparticle chemiluminescence method for hepatitis B antigen, hepatitis B large protein, hepatitis G, and human cytokeratin CK18-M30 and/or 65 testing kits are among the earliest reagent brands to obtain CFDA certification in China.
In the field of EB virus detection, the company obtained the new drug certificate for the EB virus antibody series testing kit in 2007, covering seven reagents for detecting conditions such as nasopharyngeal carcinoma and infectious mononucleosis, and has launched the EB virus affinity testing kit in China. The company’s EB product line has been continuously developed for 18 years, covering all markers for EB detection, with a high market share. At the same time, the company has independently solved the stability of core raw material supply and increased upgrades in key processes such as core raw material preparation.
Currently, Beijing Beier Bioengineering Co., Ltd. has the capability to use recombinant gene engineering for antigen preparation and processing, antibody preparation, and has achieved self-sufficiency in various core raw materials, effectively reducing production costs and enhancing the company’s core competitiveness. The company is a national high-tech enterprise and a national specialized and innovative “little giant” enterprise, receiving support from the National High Technology Research and Development Program (863 Program), and has undertaken major scientific research projects such as the national science and technology commission’s Twelfth Five-Year major project on the prevention and control of major infectious diseases such as AIDS and viral hepatitis, and the Thirteenth Five-Year major project on the development of diagnostic reagents for sudden acute infectious diseases, successfully developing multiple in vitro diagnostic products. The company has received multiple titles or honors, including Beijing Enterprise Technology Center, Jiangsu Province Science and Technology Award First Prize, and Beijing Science and Technology Award Second Prize.
2. Necessity of the Project
(1) Seizing Industry Development Opportunities to Better Meet Downstream Market Demand
In vitro diagnostics refer to products and services that obtain clinical diagnostic information by testing human samples (various body fluids, cell, tissue samples, etc.) outside the human body, thereby determining diseases or bodily functions, collectively referred to as IVD (In Vitro Diagnostic) internationally. Currently, in vitro diagnostic products are widely used in clinical medicine, spanning the entire disease treatment process from preliminary diagnosis, treatment plan selection, treatment monitoring, prognosis, and physical examination, playing a significant role in disease prevention, determining causes, and improving treatment effectiveness while reducing medical costs.
In recent years, driven by factors such as population aging, increased medical insurance coverage and expenditure, and income growth, coupled with the ability of in vitro diagnostics to provide precise, early clinical diagnostic information conveniently, at low cost, and with low harm to healthcare personnel, in vitro diagnostics have become an important basis for medical decision-making, with the market space gradually growing and expected to maintain a rapid growth rate.
According to the statistical data from the “China Medical Device Blue Book (2024 Edition),” the scale of China’s in vitro diagnostic market in 2023 is approximately 118.5 billion yuan, compared to 43 billion yuan in 2016, with an average annual compound growth rate of 15.58%. Although China’s in vitro diagnostic industry has maintained a high growth rate, the market penetration rate is still lower than that of developed regions or countries such as Europe, the United States, and Japan, indicating significant room for improvement in the future.
Based on different testing principles or methods, the in vitro diagnostic market can be subdivided into immunodiagnostics, biochemical diagnostics, molecular diagnostics, microbiological diagnostics, and blood diagnostics. According to the “China Medical Device Blue Book (2024 Edition),” immunodiagnostics occupy 42.45% of the market space. Colloidal gold and chemiluminescence are two important technical paths in the field of immunodiagnostics.
Colloidal gold, with its characteristics of simple application, rapid detection, strong stability, and single sample determination, is mainly used for instant testing in emergency departments, intensive care units, homes, and large-scale epidemiological screening; chemiluminescence, as the latest technology in the field of immunodiagnostics, is rapidly promoted in clinical applications due to its high sensitivity, good specificity, high degree of automation, precise quantification, and high accuracy. With the advancement of diagnostic technology and the expansion of application scenarios, the demand for chemiluminescence reagents and supporting instruments in medical institutions is expected to maintain rapid growth, becoming an important driving force for the development of the immunodiagnostic field and the in vitro diagnostic industry.
Moreover, due to the high difficulty of developing chemiluminescence technology and the high performance requirements for detection instruments, the domestic market is mainly dominated by multinational companies such as Roche and Abbott. In recent years, domestic enterprises have continuously strengthened their R&D investment in the field of chemiluminescence, with an increasing variety of testing projects and continuously improving instrument performance, gradually narrowing the technological gap with multinational companies; at the same time, various regulatory authorities are promoting equipment updates and strengthening policy support for high-end medical devices. In the future, the domestic chemiluminescence market is expected to continue to grow, providing good development opportunities for high-quality local enterprises with strong technological strength and brand recognition.
This project is market demand-oriented and is a strategic arrangement made by the company based on its future development planning and industry operation trends. Through the implementation of the project, the company will expand the market supply of high-quality chemiluminescence and colloidal gold in vitro diagnostic products based on its existing product matrix, targeting multiple detection fields such as respiratory pathogens, EB virus, preconception care, hepatitis, thyroid hormones, autoimmune antibodies, and tumor markers, thereby fully seizing industry development opportunities and meeting the comprehensive diagnostic and testing needs of hospitals and community clinics at all levels.
(2) Breaking Through Production Capacity Bottlenecks to Improve Production Efficiency
During the reporting period, Beier Bio’s business development momentum is good, with overall growth in revenue scale and profitability, and the market demand for various leading products is expected to continue to expand in the future. Meanwhile, the capacity and equipment utilization of the existing production and storage facilities are nearing saturation, and the issue of insufficient production capacity is beginning to emerge, with capacity utilization rates during the reporting period being 86.90%, 115.22%, and 106.15%, respectively. If capacity planning is not advanced, it will restrict business development and scale expansion to a certain extent in the future. Therefore, expanding the production capacity of core products and improving production efficiency have become urgent needs for the company to maintain a healthy development trend.
Through the implementation of this project, Beijing Beier Bioengineering Co., Ltd. will purchase land and build its own production base, supplementing advanced production, testing, and storage equipment, and expanding the employee team size to achieve expanded production of chemiluminescence in vitro diagnostic reagents and supporting instruments, as well as colloidal gold in vitro diagnostic reagents. The project will help the company create an efficient production environment, which will help the company break through production capacity bottlenecks, enhance its ability to undertake and quickly complete customer orders, and improve the speed of bringing products to market to meet the needs of rapid business development; on the other hand, it will help the company enhance the automation level of production lines, continuously improve technical processes, thereby further improving production efficiency and ensuring product quality.
(3) Deepening Main Business Development to Build and Strengthen Market Competitive Advantage
The company focuses on the research, development, production, and sales of in vitro diagnostic reagents and supporting instruments. Since its establishment, the company has adhered to deepening its focus on key diagnostic fields, continuously enhancing the depth and breadth of its product series operational strategy, and has established platforms for enzyme-linked immunoassay reagents, POCT rapid diagnostic reagents, magnetic microparticle chemiluminescence diagnostic reagents, diagnostic instruments, and biomaterials, with applications primarily in respiratory pathogen detection, covering multiple testing fields such as preconception care, hepatitis, EB virus, and autoimmune antibodies, achieving coverage of all application scenarios from professional laboratories to grassroots medical institutions.
Through the implementation of this project, the company will achieve expanded production of chemiluminescence in vitro diagnostic reagents and supporting instruments, as well as colloidal gold in vitro diagnostic reagents, while achieving a business closed loop of “equipment + reagents,” enhancing the overall solution capability of the diagnostic system. The implementation content of the project is highly related to Beier Bio’s existing main business, which will help deepen the development of advantageous business areas, stabilize the foundation for development, and continuously enhance the market share of each leading product, thereby building and strengthening market competitive advantages.
3. Project Feasibility
(1) The Project Implementation Has a Good Policy Environment
The company’s main business is the research, development, production, and sales of in vitro diagnostic reagents and supporting instruments. In recent years, the state has issued a series of laws, regulations, and industrial policies to support the development of the in vitro diagnostic industry. In May 2022, the National Development and Reform Commission released the “14th Five-Year Plan for the Development of the Bioeconomy,” which clearly proposed to “vigorously develop advanced diagnostic technologies and products such as molecular diagnostics, chemiluminescence immunodiagnostics, and instant testing.” The latest revised version of the “Regulations on the Supervision and Administration of Medical Devices” officially came into effect in June 2021, and the latest revised versions of the “Regulations on the Supervision and Administration of Medical Device Production” and “Regulations on the Supervision and Administration of Medical Device Business” officially came into effect in May 2022.
In August 2021, the State Administration for Market Regulation issued the “Registration and Filing Management Measures for In Vitro Diagnostic Reagents,” categorizing in vitro diagnostic reagents and stipulating regulations on product classification and naming, product technical requirements, registration inspection, clinical evaluation, and product registration, aiming to standardize the registration and filing behavior of in vitro diagnostic reagents, ensuring the safety, effectiveness, and quality control of in vitro diagnostic reagents.
With the national emphasis on the development of the medical industry and the biotechnology industry, in vitro diagnostic enterprises that adapt to market demand, possess core competitive advantages, and have continuous innovation capabilities will gain opportunities for rapid development in the upgrading of the domestic medical industry. The current industrial policies provide a good external environment and opportunities for the company’s business development.
(2) The Project Implementation Has a Good Market Environment
In recent years, benefiting from the progress of diagnostic technology, the increase in the intensity of medical insurance policies, and the improvement of national health awareness, the market demand for domestic in vitro diagnostic products has continued to be released, with broad development space in the future.
According to data released in the “China Medical Device Blue Book (2024 Edition),” the scale of the domestic in vitro diagnostic market reached 118.5 billion yuan in 2023, compared to 43 billion yuan in 2016, with an average annual compound growth rate of 15.58%; immunodiagnostics have become the largest sub-market in the domestic in vitro diagnostic industry, with a market scale of 50.3 billion yuan in 2023, a year-on-year growth of 13%, accounting for 42.45% of the market share in the in vitro diagnostic industry, a year-on-year increase of 5.27%; chemiluminescence, as the latest technology in the field of immunodiagnostics, reached a domestic market scale of 32.79 billion yuan in 2022, with a compound annual growth rate of approximately 22.44% from 2016 to 2022, significantly higher than other sub-sectors of the in vitro diagnostic industry, and is expected to maintain a high growth trend in the future.
Therefore, the market space for the products of this project is broad, and the project implementation has a good market environment.
(3) The Company Has Solid Technical Reserves
The company has always regarded technological innovation as its primary development goal, committed to the research and development of in vitro diagnostic reagents and instruments, and has established five major technical platforms: enzyme-linked immunoassay reagent platform, POCT rapid diagnostic reagent platform, magnetic microparticle chemiluminescence in vitro diagnostic reagent platform, diagnostic instrument R&D and production platform, and biomaterials platform, forming a solid core technology reserve. As of April 30, 2025,
the company has obtained 459 domestic medical device registration certificates/filing certificates, including 168 Class III medical device registrations, 239 Class II medical device registrations, and 52 Class I medical device filing certificates, covering testing reagents for respiratory pathogens, preconception care, hepatitis viruses, EB viruses, gastrointestinal tract, autoimmune antibodies, and other detection directions, and has independently developed fully automated magnetic microparticle chemiluminescence immunoassay analyzers and other supporting diagnostic instruments, forming a rich and clear product system.
The company actively invests in R&D team building, establishing the Beijing Enterprise Technology Center, and has successfully built a high-quality R&D team. Core R&D personnel have diverse professional backgrounds in biological cell science, biochemistry, microbiology, bioengineering, immunology, and mechanical and electronic engineering, possessing rich experience in technology R&D and application. Many R&D personnel have participated in major product projects of the National Science and Technology Commission’s “863 Program,” the National “Twelfth Five-Year” project, the National “Thirteenth Five-Year” project, and the Beijing Municipal Science and Technology Commission. The solid technical reserves and strong R&D team provide a solid technical foundation for project implementation.
(4) The Company Has a Complete Marketing Network and Rich Market Resources
The industry in which the company operates is mainly based on distribution, complemented by direct sales. The geographical distribution of medical institutions in China is extremely broad, and medical device companies need to cultivate distribution teams for long-term business development to establish a complete sales network. The business development capabilities of the distribution team directly affect whether the company can gain an advantage in market competition. After years of development, the company has formed a complete sales and service network system across the country, covering medical institutions at the county level and above in more than 30 provinces, municipalities, and autonomous regions.
Relying on excellent and stable product performance, the company has won high recognition from numerous distributors, terminal hospitals, and third parties, and has accumulated many high-quality distributors and customer resources in the domestic market, with a high brand awareness. Through regular communication with distributors and customers, the company quickly obtains the latest market dynamics, continuously promotes the optimization of its R&D and marketing strategies, helping the company gain an advantageous position in market competition. A complete marketing network and rich market resources can provide strong support for the market digestion of new production capacity.
4. Project Investment Estimate
The total investment for this project is 441.8081 million yuan, with construction engineering costs of 114.9843 million yuan; equipment purchase and installation costs of 235.3580 million yuan; other engineering construction costs of 30.4192 million yuan; basic reserve funds of 19.0381 million yuan; and working capital of 42.0086 million yuan.
5. Project Implementation Schedule
The construction period of this project is 36 months, and the project schedule includes preliminary preparation, site construction and decoration, equipment purchase and installation, personnel recruitment and training, and production operation.
6. Project Economic Benefits
According to the feasibility study report, after reaching full production capacity, the project is expected to achieve annual sales revenue of 559.8691 million yuan (excluding tax), with a static investment payback period of 6.38 years (after tax, including a construction period of 2 years), and an internal rate of return on investment (after tax) of 23.93%, indicating good economic benefits.
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