Boji Bio Advances Differentiated R&D Amid Domestic Substitution Trend: Fully Automated Chemiluminescent Immunoassay Analyzer Receives Approval and IPO Filing Submitted
The COVID-19 pandemic has accelerated the process of domestic substitution for in vitro diagnostics.
Zhao Jun, founder of Baiji Biotech, told VCBeat that prior to the COVID-19 pandemic, over 70% of the instruments and reagents used for immunoassays, clinical chemistry assays, microbiological testing, and molecular diagnostics in Grade A tertiary hospitals were from imported brands. Domestic brands were limited to a few clinical chemistry and immunoassay items, such as the eight preoperative hepatitis markers, tumor markers, and hormone tests, highlighting a pronounced import monopoly.
Founded during a period of opportunity for the domestic substitution of in vitro diagnostics (IVD), Baiji Biotechnology has established a strategic layout encompassing reagent raw materials, chemiluminescence, and molecular diagnosis platforms. The company has independently developed products such as fully automated chemiluminescence immunoassay analyzers and NS3 antigen proteins. In August 2022, it obtained registration certificates for eight IVD reagent products, emerging as a new force in the field of in vitro diagnostics.
Amid policy support and the continuous expansion of medical demand, the in vitro diagnostics (IVD) industry has entered a period of robust growth. According to Frost & Sullivan, the market size of China’s IVD industry is projected to reach RMB 195.7 billion in 2024, with a compound annual growth rate (CAGR) of approximately 17.8% from 2019 to 2024, maintaining its rapid growth momentum.
Zhao Jun, founder of Baiji Biotech, has over 20 years of experience in the in vitro diagnostics (IVD) industry, with extensive expertise in both IVD technology R&D and market sales. He has witnessed the entire evolution of China’s IVD market, from its inception and early stages to its current booming development.
In the early days, China’s in vitro diagnostics (IVD) market was largely undeveloped, with domestic companies mostly in their infancy. In contrast, the IVD industry abroad had an earlier start, with European and American brands benefiting from years of accumulation and offering mature, stable products. Therefore, Zhao Jun initially chose to deepen his presence in China’s IVD market by distributing imported brands. He established Huayu Company in 2003, accumulating substantial technical expertise and robust channel resources, and covering more than 50 hospitals across China.
In 2019, as China’s healthcare reform deepened, policy support for domestic brands was strengthened.Zhao Jun keenly recognized that import substitution in the in vitro diagnostics (IVD) sector was an inevitable trend, and thus founded Baiji Biotech to independently develop a series of products, including raw materials for hepatitis C diagnostic reagents, chemiluminescence platforms, and molecular diagnostics.
Now, the wisdom of Zhao Jun’s forward-looking strategy to position domestically produced in vitro diagnostic (IVD) products has been validated. In the post-pandemic era, the process of domestic substitution for IVD products in China has significantly accelerated.
Domestic substitution has become a key focus area at the policy level.The “14th Five-Year Plan” for the Development of the Medical Equipment Industry proposes to strengthen breakthroughs in original and leading medical equipment, aiming to elevate the research and development, manufacturing, and application of medical equipment to an advanced global level by 2035, thereby positioning China among the forefront of innovative nations in the medical equipment sector.
In 2021, the “Guiding Opinions on Promoting the Healthy Development of the Pharmaceutical Industry,” issued by the General Office of the State Council, explicitly stated that government procurement projects shall, in principle, procure domestically produced products if Chinese-made drugs and medical devices can meet the requirements, with a view to gradually raising the level of domestic equipment configuration in public medical institutions. Dozens of provinces, municipalities, and autonomous regions, including Guangdong, Shaanxi, Shandong, Shanghai, Fujian, and Jiangsu, have clearly stipulated in their published government procurement policies that imports of medical devices shall be strictly restricted and domestic products supported.
Furthermore, in 2021, the “Announcement on Negotiated Price Bargaining for the Centralized Volume-Based Procurement of Clinical Laboratory Reagents by Public Medical Institutions in Anhui Province” was released, officially kicking off provincial-level centralized volume-based procurement for chemiluminescence assays and further accelerating the domestic substitution of in vitro diagnostics.
However, it should be noted thatCompetition in China’s In Vitro Diagnostics Sector Is Becoming Increasingly Fierce, "brute-force" domestic substitution is no longer viable.Zhao Jun has served as an agent for imported brands for many years, possessing deep insight into the clinical needs and pain points of China’s in vitro diagnostics (IVD) market.Centered on the urgent clinical needs, the companyImplemented differentiated and refined strategic layouts in raw materials, immunology, and molecular diagnostics.
Amid the booming development of the in vitro diagnostics (IVD) market, increasingly fierce competition is an unavoidable issue.Baiji Biotech’s core strategy is to prioritize product quality and technological differentiation.Zhao Jun stated, “Our philosophy is not to compete on price or produce commoditized products; instead, we focus on identifying unmet clinical needs in underserved areas.”
In the niche segment of chemiluminescence immunoassays, large-scale chemiluminescence analyzers currently used in hospital clinical laboratories are predominantly carousel-based and utilize bulk reagent kits, with the smallest packaging unit typically containing at least 100 tests. Due to the relatively short shelf life of these reagents, failure to consume them promptly after loading onto the instrument can result in significant waste.
“Nowadays, clinical laboratories conduct cost accounting on a per-test basis; therefore, we have developedFully automated chemiluminescence immunoassay analyzer with a disposable single-use reagent cartridge design.“Zhao Jun stated.
The fully automated chemiluminescence immunoassay analyzer developed by Baiji Biotechnology preloads all reagents and consumables into reagent cartridges, effectively preventing waste caused by the expiration of opened bulk reagent packages. The instrument also features a smaller footprint and lower costs. Meanwhile, the company has retained a carousel-based design rather than a plate-based one, enabling higher throughput to meet the demands of clinical laboratory departments.
Single-test chemiluminescence assays have been widely adopted in the point-of-care testing (POCT) sector. However, given the high specimen volume in clinical laboratories, high-throughput single-test instruments offer greater competitiveness. “In simple terms, we have integrated POCT with large-scale chemiluminescence immunoassay analyzers. By employing single-test reagents, we eliminate the reagent waste associated with traditional large-scale instruments, enabling clinical laboratories to achieve true per-test cost efficiency, while retaining the testing throughput and performance of conventional large-scale chemiluminescence immunoassay systems.”
Leveraging fully automated chemiluminescence immunoassay analyzers, Baiji Biotechnology is strategically positioning itself in the unique application scenario of thrombophilia.
Thrombophilia is characterized by an increased risk of thrombosis due to a persistent hypercoagulable state. Numerous studies have demonstrated that many adverse pregnancy outcomes are associated with thrombophilia, such as hypertensive disorders of pregnancy, placental abruption, fetal growth restriction, and unexplained recurrent miscarriage. Therefore, timely and accurate testing for thrombophilia is crucial.
Historically, the diagnosis of thrombophilia required the assessment of multiple markers. As different markers necessitated distinct methodologies—such as coagulation, biochemical, and immunological assays—multiple samples were needed to perform these various tests before results could be obtained.Baiji Bio integrates multiple methodologies onto a chemiluminescence platform, enabling thrombophilia testing with a single blood sample on one instrument, thereby significantly reducing report turnaround time.。
In the raw materials business, the NS3 antigen proteins commonly available on the market for hepatitis C diagnosis struggle to achieve their native conformation, resulting in insufficient specificity.The NS3 antigen protein developed by Baiji Biologics features a purely native conformation, exhibits excellent specificity, and has a purity greater than 90%, making it suitable for various diagnostic platforms such as chemiluminescence immunoassay (CLIA) and enzyme-linked immunosorbent assay (ELISA).
Baiji Biotech's High-QualityNS3 antigen protein has been supplied to multiple domestic hepatitis C diagnostic reagent manufacturers, helping hepatitis C diagnostic reagents go global,Sales have expanded into broader overseas markets. Next, the company will develop more high-value raw material products.
In the molecular diagnostics business, Baiji Bio focuses on gastrointestinal tumors and is developing oncogene screening technologies for gastrointestinal cancers.
Currently, Baiji Biotech’s fully automated chemiluminescence immunoassay analyzer and eight associated reagents have obtained registration certificates, and the company will accelerate market promotion in the second half of 2022. Going forward, the company will pursue both innovative product development and accelerated market expansion. Zhao Jun stated, “The in vitro diagnostics (IVD) sector will continue to maintain rapid growth. In the future, IVD will integrate more disciplines such as automation and computer science. We will bring together multidisciplinary talent to jointly advance technological progress in in vitro diagnostics.”