Yinjia Bio: Leveraging a High-End Protein Platform to Build an Integrated Ecosystem from Premium Protein Reagents to Companion Diagnostics for Innovative Therapies

Raw materials serve as the source of innovation in the in vitro diagnostics (IVD) industry and the cornerstone of key product performance, exerting a profound impact on the performance and accuracy of diagnostic reagents. To develop high-end diagnostic products, it is imperative to first master the processes and technologies for designing and producing core raw materials, particularly the technologies for core raw materials such as high-end proteins.

Data shows that the market size of in vitro diagnostics (IVD) raw materials in China accounts for approximately 10% to 15% of the overall diagnostic products market, exceeding RMB 7 billion in 2018. The unprecedented opportunities and challenges brought by the 2020 COVID-19 pandemic to the IVD sector have also provided a practical paradigm for how enterprises can pursue deeper development and build stronger competitiveness in the future.

Over the past 10-plus years, a number of prominent companies dedicated to the R&D of raw materials for in vitro diagnostic (IVD) reagents have emerged in the market, including Fapon Biotech and Vazyme.However, high-end core raw materials such as enzymes, antigens, and antibodies used in next-generation sequencing, molecular diagnostics, and immunodiagnostics still heavily rely on foreign imports, hindering the independent research and development process of China's high-end and innovative in vitro diagnostic products.For example, during the COVID-19 pandemic, dozens of nucleic acid testing kits were approved in China. However, the high-end enzymes used in these testing reagents remain largely imported, leaving the domestic industry constrained by a "chokehold" dilemma.

Undoubtedly,DevelopmentInnovative in vitro diagnostic (IVD) raw materials with proprietary intellectual property rights and performance comparable to world-class products have become the key to the long-term and stable development of China's IVD industry.

Roche is a global leader in the in vitro diagnostics industry.Dr. Wu Yifei, who previously served as a Senior Scientist at Roche Diagnostics US specializing in core raw materials and immunodiagnostic products, has successfully developed a series of novel drug targets and diagnostic raw materials over his career spanning more than two decades. Accumulating extensive experience in the development of diagnostic raw materials and reagent products, he has emerged as a leading figure in the high-end core raw materials sector and the in vitro diagnostic (IVD) reagent industry.

More than a decade after returning to China from the United States, Dr. Wu Yifei has successively served as Executive Director of the Protein Science and Biotechnology Platform at Crown Bioscience and WuXi AppTec. Under his leadership, the team has not only supplied high-purity, high-activity target proteins for high-throughput screening in novel drug discovery to dozens of pharmaceutical and biotechnology companies—including Merck, GlaxoSmithKline (GSK), BioMarin, AstraZeneca, Pfizer, and Genentech—but also provided high-quality drug-target protein co-crystals and structural elucidation for lead compound optimization. Concurrently, the platform delivers a comprehensive suite of high-quality technical outsourcing services, encompassing process research and development for protein-based orphan drugs, as well as biomarker identification and detection.

In August 2015, Dr. Wu Yifei was invited to rejoin WuXi AppTec, serving as Vice President and General Manager of the Clinical Diagnostics Division. He was responsible for establishing and fully overseeing personalized clinical diagnostic services, as well as the strategy and operations for the introduction, development, standardized domestic production, and commercialization of the latest overseas in vitro diagnostic (IVD) products, alongside the co-development of novel drugs and companion diagnostics. Over a period of more than three years, Dr. Wu leveraged his extensive hands-on operational, managerial, and regulatory experience across both the pharmaceutical and diagnostic sectors to build a comprehensive, multi-dimensional diagnostic technology platform encompassing molecular diagnostics, immunoassays, mass spectrometry, and molecular pathology. He also established an IVD product manufacturing base compliant with GMP quality systems, laying a solid foundation for WuXi AppTec’s strategic layout in the clinical diagnostics business.

Addressing the long-standing foreign monopoly on China's high-end core raw materials, Dr. Wu Yifei stated that historically, the domestic in vitro diagnostic (IVD) raw material industry lacked top-tier talent, leading to fragmented industry resources, insufficient R&D capabilities, suboptimal performance of core raw materials, and poor process stability. Moving forward,With the involvement of more outstanding talents and increased investment in interdisciplinary cutting-edge technologies, the rapid development of China's high-end core raw materials industry will be significantly accelerated, effectively breaking through the "bottleneck" dilemma.

In late 2020, Dr. Wu Yifei founded YINJIA BIOSCIENCES (abbreviated as “YINJIA BIOSCIENCES”) to target the high-end protein raw materials and companion diagnostics market. Drawing on past experience in successfully developing over 150 high-end proteins, and leveraging a suite of advanced technologies including computer simulation and AI-assisted design, the company has established a comprehensive protein development platform. This platform provides high-quality, hard-to-replicate, highly stable, and cost-effective high-end protein raw materials for clinical diagnostics, personalized medication guidance, and new drug development, benchmarking against top-tier international enterprises. Meanwhile, relying on its independently developed innovative core raw materials, YINJIA BIOSCIENCES will further develop companion diagnostic products to support innovative therapies and address unmet clinical needs. Through a dual-business-line layout encompassing high-end protein raw materials and companion diagnostic products,To establish a biotechnology company that operates a closed-loop model, starting from upstream core raw materials and extending to the development and support of cutting-edge innovative therapies.

High-end proteins are crucial raw materials for the R&D of in vitro diagnostic (IVD) reagents, characterized by high market demand and high barriers to entry. Meanwhile, drug target proteins represent a key breakthrough in new drug development. As high-quality drug target proteins constitute the first step in this process, developing technically challenging target proteins is of paramount importance.

However, China remains heavily reliant on imports for high-end proteins. Although domestic capabilities have improved significantly in recent years, a gap still exists in certain core raw materials compared to top-tier international products. For instance, CK-MM antibodies have long been monopolized by Roche, while key enzymes for NGS and critical enzyme raw materials for glycated hemoglobin and glycated albumin testing are monopolized by Japanese enterprises.With the launch and implementation of the "Healthy China 2030" Planning Outline, and coupled with the development of China's favorable policy environment that encourages innovation and original research, domestic enterprises' demand for import substitution of core protein raw materials is growing increasingly strong.

Currently, high-end protein platforms in China are predominantly focused on pharmaceutical R&D and international outsourcing services, with limited involvement in the diagnostics market. Therefore, YINJIA BIOSCIENCES utilizes high-end specialty proteins as an entry point to establish a presence in the companion diagnostics market for innovative therapies. By leveraging computer simulation, artificial intelligence, and protein engineering, the company develops innovative, high-demand, and high-barrier-to-entry high-end proteins/enzymes, as well as antigens and antibodies. This strategy not only addresses the domestic shortage of core diagnostic raw materials currently dependent on imports, but also fulfills the requirements for the early-stage development and optimization of innovative biologics and small-molecule chemical drugs.

YINJIA BIOSCIENCES' proprietary protein optimization platform (CFPS) features a small reaction volume, short reaction cycle, open expression system, and a stable, continuous reaction system, which can significantly shorten the development time for difficult-to-express proteins.Leveraging the Protein Selection Platform, YINJIA BIOSCIENCES will develop a series of high-end core proteins for in vitro diagnostics (antibodies, antigens, and enzymes) and novel drug target proteins, while providing customized protein services to innovative pharmaceutical companies.

Within just a few months of its establishment, YINJIA BIOSCIENCES has successfully developed high-activity products comparable to those of Roche, includingRecombinant trypsin (r-Trypsin), calcineurin (PP2B)...and several other unique raw materials. Other raw material products with high market demand and high technical barriers will also be launched in the near future. Meanwhile, custom development services for pharmaceutical and biotechnology companies are also progressively being rolled out.

In the near future, YINJIA BIOSCIENCES will develop more high-end core raw materials, laying a solid foundation for the development of diagnostic products for the early diagnosis of malignant tumors, companion diagnostics, and postoperative testing. YINJIA BIOSCIENCES looks forward to collaborating with other leading enterprises to contribute to the rapid development of China's in vitro diagnostics (IVD) and biopharmaceutical industries.

In recent years, pharmaceutical companies have placed increasing emphasis on and reliance upon companion diagnostic companies. According to data from MarketsandMarkets, the global companion diagnostics market size was USD 3.13 billion in 2018. The global market is projected to reach USD 3.76 billion, USD 4.51 billion, USD 5.42 billion, and USD 6.51 billion in 2019, 2020, 2021, and 2022, respectively, representing a compound annual growth rate (CAGR) of 22.78% from 2016 to 2022. This significantly outpaces the 6% growth rate of the broader global in vitro diagnostics (IVD) industry. In China, the companion diagnostics market was approximately USD 300 million in 2018, registering a CAGR of 28% from 2012 to 2020, which markedly exceeds the roughly 15% growth rate of China’s domestic IVD sector. As of March 2021, the U.S. FDA had approved a total of 44 companion diagnostic products, the vast majority of which are associated with oncology treatments.

Companion diagnostics can maximize the efficacy and safety of disease treatment, serving as a vital component of personalized medicine and one of the key focuses in the long-term strategic layout of YINJIA BIOSCIENCES.Starting with the establishment of a comprehensive protein platform, YINJIA BIOSCIENCES has gradually expanded to develop unique, high-quality raw materials for innovative downstream companion diagnostic products, laying the foundation for high-performance diagnostic products.In the mid-to-long term, YINJIA BIOSCIENCES will gradually enter the companion diagnostics market. Backed by its robust capabilities in the independent development of core raw materials, the company will collaborate with top-tier domestic and international research institutions and universities, such as Johns Hopkins University in the United States. Driven by a dual-engine strategy of technology introduction and independent R&D, it will rapidly advance the commercialization of diagnostic kits for the early detection of malignant tumors, alongside companion diagnostic products that support the R&D of Class I innovative drugs, to ultimately fulfill the mission and founding vision of YINJIA BIOSCIENCES.

Upon its establishment, YINJIA BIOSCIENCES immediately attracted the attention of numerous investors. In January 2021, the company completed an angel financing round of tens of millions of RMB, led by CDH Investments and participated in by Furong Investment. Currently, to accelerate strategic layout and advance the market launch of innovative products, additional investments for the Pre-A round are also progressing smoothly. Regarding the company's vision, Dr. Wu Yifei stated: “A successful R&D platform relies on three pillars: capital, resources, and integration. Innovation and high quality form the core of platform development."We are deeply honored to have received the trust and support of CDH Investments and Furong Investment since the infancy stage of our platform’s development. This has empowered us to integrate cutting-edge interdisciplinary science and technology into our platform and promptly secure resources dedicated to pursuing original innovation and the spirit of craftsmanship. We will strive relentlessly, remain true to our founding mission, stay grounded, and take steady, deliberate steps toward the shores of success."