DaiAn Biotech Files IPO Prospectus: Self-Sufficient in IVD Reagents and Core Raw Materials to Empower Domestic Innovation

Raw Materials for In Vitro Diagnostics (IVD) constitute the most fundamental segment of the IVD reagent industry chain. Although the market for IVD reagent raw materials in China is currently modest in scale, the economic value and strategic importance of core IVD raw materials are becoming increasingly prominent. This trend is driven by the continuous advancement of diagnostic technologies, as well as multifaceted demands for new product development, upgrading of existing products, and cost control.

Due to the late start of China’s in vitro diagnostics (IVD) sector, raw material preparation processes have not yet fully matured. As a result, certain antigens, antibodies, and high-end raw materials in China still rely on imports. The monopoly held by foreign manufacturers has led to persistently high costs and heightened risks of supply disruptions. Recognizing these pain points in the IVD field, Lan Ping and a group of senior immunology experts and overseas returnees founded Wuhan Dian Biotechnology Co., Ltd. (hereinafter referred to as “Dian Bio”) in 2015.

Dian Bio specializes in immunology and protein quantification technologies, focusing on the R&D of IVD raw materials and technical services. The company boasts comprehensive systems for protein expression, antibody preparation, and diagnostic reagent development.Currently, the company has reached a leading level in China in protein expression and purification, natural protein extraction, and antibody research and development and production.

Lan Ping, Founder and General Manager of Dian Diagnostics, stated, “The R&D of raw materials for in vitro diagnostic reagents is highly challenging, with certain difficulties that are hard for professionals from other industries to comprehend.” She identified three major challenges in raw material R&D.

Long R&D cycle.“Taking antibody raw materials as an example, even under smooth R&D conditions, it takes one year to complete the development of a single antibody raw material. If the first round of R&D fails, the process must be restarted.” Therefore, the lengthy R&D cycle for raw materials imposes high demands on a company’s cash flow management. According to Lan Ping, Dian Bio currently achieves an annual sales growth rate of 100%. With ample capital reserves, the company is well-positioned to ensure the orderly progression of various raw material R&D projects.

High technical requirements for R&D and production.The research and development (R&D) and production of raw materials involve fields such as molecular biology, biochemistry, and immunology, requiring R&D personnel to possess extensive and broad knowledge. Within the entire industrial chain for the R&D and production of diagnostic reagents, the development of core in vitro diagnostics (IVD) raw materials encompasses products such as antigens, antibodies, and enzymes. This requires R&D personnel to have advanced expertise in molecular biology and biochemistry, as well as a certain level of clinical diagnostic knowledge.

“Acquiring this type of knowledge is a slow process, and applying it to research and development is also arduous; working in the IVD raw materials industry requires long-term accumulation and refinement,” Lan Ping remarked.

High learning ability is required for raw material R&D personnel.Lan Ping believes, “Since different raw materials require different technical routes, there are significant differences between projects, making R&D technologies and experience difficult to replicate. Therefore, raw material R&D personnel should possess the ability to engage in continuous learning.” In addition, R&D personnel need to promptly conduct research and development targeting new biomarkers. These requirements demand that R&D professionals stay abreast of the latest developments in the in vitro diagnostics (IVD) field and continuously acquire new knowledge.

The founding team of Dian Diagnostics comprises seasoned professionals in the raw materials industry for in vitro diagnostic (IVD) reagents, with expertise spanning technical R&D, laboratory management, and marketing and sales.

Lan Ping graduated from Tongji Medical College of Huazhong University of Science and Technology and Wuhan University, holding a Ph.D. in Molecular Virology, and conducted postdoctoral research at Illinois State University in the United States. Upon returning to China, she worked at Wuhan Sanying Biotechnology Co., Ltd. for over ten years, successively serving as Production Supervisor, Vice President, and President, thereby accumulating extensive experience in technical development and corporate management. The founding team of Dai An Biology also includes Zeng Fanming, Hu Zhiyong, Ran Kaikai, and others, who possess rich experience in product R&D, corporate process management, and marketing sales. Through their collaborative division of labor, the company has secured robust capabilities in R&D, production technology, and marketing sales, enabling it to address various challenges in the raw material R&D industry.

It is understood that Dian Bio has established a comprehensive workflow encompassing antigen purification for in vitro diagnostics (IVD), antibody preparation, reagent development, and clinical trials. By integrating all key steps across the entire IVD reagent production process, the company has laid a solid foundation for the research, development, and manufacturing of high-quality diagnostic reagents.Currently, the diagnostic kits and key core raw materials provided by the company are all self-supplied, ensuring long-term, large-scale, and stable product supply.

Currently, Dian Biotech has launched raw materials including polyclonal antibodies, monoclonal antibody pairs, proteins/antigens, and pathological diagnostic antibodies. The reagents produced from these materials are applicable to multiple disease areas, such as infectious diseases and diabetes. The company’s commercially available test kits fall into two main categories: biochemical diagnostic kits and ELISA kits.

Among them,The SAA Latex-Enhanced Immunoturbidimetric Assay Kit and the Alpha-Fetoprotein Latex-Enhanced Immunoturbidimetric Assay Kit are among the company’s flagship products.

Serum Amyloid A (SAA) is a critically important infection marker in clinical practice. Dian Biotech’s SAA latex-enhanced immunoturbidimetric assay is designed for the in vitro quantitative measurement of SAA levels in human serum or plasma. This product features liquid calibrators, a linear range of 3–500 mg/L, and a sensitivity of <1 mg/L. It demonstrates a clinical concordance rate of up to 95% compared with Japanese-brand kits.

Furthermore, alpha-fetoprotein (AFP) is currently the only tumor marker for hepatocellular carcinoma recommended for routine clinical use, and it remains the most commonly used serological marker for primary liver cancer. It has been widely applied in liver cancer screening, diagnosis, and prediction of recurrence. The AFP latex-enhanced immunoturbidimetric assay kit developed by Dian Bio is designed for the quantitative in vitro determination of protein levels in human urine, with a linear range of 2–800 mg/L and a sensitivity of 2 µg/L. Compared with chemiluminescence assay kits from major international brands, it demonstrates a clinical concordance rate of 95%.

Notably,Dian Biotech is one of the few companies in China capable of providing custom rat monoclonal antibody and rabbit monoclonal antibody projects.

The company’s custom rat and rabbit monoclonal antibody projects feature picomolar (pM) affinity and high specificity, enabling the recognition of both human proteins and their mouse homologs, thereby overcoming immune tolerance caused by antigenic homology in mouse protein antibody development.

Additionally, Dian Bio has recently launched a custom neutralizing antibody service. The company employs self-developed special adjuvants and specialized immunization protocols, which are particularly suitable for the preparation of neutralizing antibodies against pathogens such as viruses and Mycoplasma. The resulting antibody titers are 10 to 100 times higher than those achieved with internationally recognized commercial adjuvants.

Leveraging its robust product R&D capabilities, Dian Bio also provides one-stop CRO services to diagnostic reagent manufacturers, covering raw material preparation, raw material validation, and diagnostic reagent development. This helps diagnostic companies establish product lines with independent intellectual property rights. To date, the company has developed high-quality raw materials for numerous enterprises and research institutes, establishing long-term collaborative partnerships with them.

The rapid growth of the in vitro diagnostic (IVD) reagent industry has spurred demand in the raw materials market. In 2017, the market size of China’s IVD reagent industry reached RMB 40 billion, with IVD reagent raw materials accounting for approximately 10% of this total, indicating a raw materials market size of around RMB 4 billion.

Lan Ping stated, “Foreign raw material giants boast long histories, robust technical capabilities, diverse product portfolios, and extensive marketing channels, whereas most Chinese in vitro diagnostic (IVD) reagent raw material enterprises were established within the past decade and are relatively young. Therefore, foreign giants will continue to hold a competitive advantage for some time to come; only by achieving breakthroughs in core raw materials can domestic companies break the current monopoly.”

Currently, Dian Biotech is developing raw materials targeting new therapeutic targets for cardiovascular diseases. Core raw materials that have not yet broken the foreign monopoly, such as certain enzyme-based materials, chemiluminescence reagents, and blocking monoclonal antibodies, will be the focus of the company’s future R&D efforts, with the aim of breaking the foreign monopoly at an early date.

In addition, Lan Ping stated that with the growth of the national economy and the government’s increased emphasis on healthcare, China’s public health system has been continuously improved, driving the rapid development of the health checkup and home diagnostic markets. “Going forward, Dian Bio will focus on raw material R&D for the health checkup and home diagnostic markets.”