Kaiji Bio Advances Open Innovation Ecosystem to Accelerate Life Science Commercialization

As a critical segment of the upstream life science industry chain, China’s biological reagent sector has long been dominated by foreign brands. Key raw materials for biological reagents represent a crucial “chokepoint” in terms of technology and products, serving as an essential prerequisite for downstream biopharmaceutical enterprises to achieve autonomous, controllable, and sustainable industrialization of their products.

In recent years, upstream biological reagents have garnered increasing attention, benefiting from the robust growth of China’s innovative drugs, basic scientific research, and in vitro diagnostics (IVD) sectors. The three-year COVID-19 pandemic further raised the ceiling for the biological reagent industry, intensifying market competition. This has also driven the evolution of customers’ personalized demands, compelling companies to strengthen R&D investment and launch customized products and technical services.

Supported by strong national policies, the biological reagents sector, as a foundational tool for life sciences research and applications, will continue to benefit. “Import substitution, overcoming chokehold technologies, and breakthroughs in core technologies” are currently the key pain points in China’s biological reagents industry, as well as the primary drivers of its explosive growth.

Sun Yijun, Chairman of NANJING KEYGEN BIOTECH.CO.,LTD., stated that among the three major segments of biological reagents, leading companies have already emerged in the molecular and protein fields. In contrast, the cell biology segment has long been dominated by imported products, with no domestic company yet going public. Leveraging its industry expertise, NANJING KEYGEN BIOTECH will focus on the life sciences cell biology sector over the next three years. By adopting a strategy of “independent development and autonomous control,” the company aims to develop more reagent products whose quality, variety, and efficiency can benchmark against international brands. Whether serving research or industrial applications, we strictly maintain quality standards, establishing R&D, quality control, and production systems aligned with industrial-grade requirements to meet the growing high-quality demands of domestic scientific research and clinical applications.

Nanjing KeyGen Biotech Co., Ltd. is a life sciences brand supplier deeply engaged in life science products and services, with a focus on differentiated specialty diagnostic technologies. Leveraging core technologies in cell biology, protein and immunology, and molecular biology, the company has established a comprehensive independent R&D, production, and sales system in the fields of biological reagents and diagnostic reagents, achieving self-controllability for certain core biological raw materials.

In accordance with the company’s latest three-year strategic plan (2023–2025), the company has accelerated its focus on attracting talent and investing in independent R&D for core technologies related to cell biology reagents with extremely low domestic production rates, such as cell transfection reagents and specialized cell culture media. Leveraging the established distribution channels in cell biology, the company has expanded its product portfolio to include single-use cell culture consumables and cell-related instruments and equipment, thereby enhancing customer stickiness.

Nanjing Keygen Biotech, established in 2000 as a state-controlled research institution dedicated to novel anti-cancer drugs, achieved breakthroughs in nucleic acid therapeutics within just four years of its founding and secured multiple international invention patents.

In 2006, leveraging its technological achievements and resource accumulation in the field of innovative drugs, Keygen Biotech aligned with market demands by implementing a series of business adjustments, becoming one of the earliest domestic biotechnology companies in China to provide cell reagent products and biotechnological services. In 2014, as a pilot enterprise for mixed-ownership reform among local state-owned technology firms, the company introduced strategic investments to achieve diversified reforms in its systems and mechanisms. It was listed on the National Equities Exchange and Quotations (NEEQ) in early 2016, successively attracting interest from institutions such as Yuexiu Industrial Fund, Dongpingheng Capital, Huatai Securities, GF Securities, and Guotai Junan Securities.

According to Huang Ying, General Manager of Keygen Biotech, the company’s current core business is divided into three major segments: life science products and services, clinical diagnostic products and services, and comprehensive laboratory solutions. Its business reaches a broad downstream market spanning basic life sciences research and translational medicine applications.

In the field of basic life sciences research, KeyGen Biotech provides biological reagent products and scientific research technical services. The company possesses core technologies including plasmid vector construction, molecular cloning, and high-purity, high-activity protein expression. It has established five major product libraries comprising 24 product lines and seven life science technology service platforms, and has introduced and developed a high-quality human tumor cell bank containing more than 300 cell strains.

In this field, the company’s star product lines include cell culture, apoptosis detection, cell proliferation assays, Western blotting, and fluorescent probe series, along with over 1,000 technical service solutions. Core raw materials are now fully independently sourced and controlled. Its Annexin V, TUNEL, Caspase detection, and protein purification product series have received high acclaim. According to SCI-HUB literature search data, more than 50,100 SCI-indexed papers have been published domestically and internationally using its products, with the highest impact factor reaching 63. This performance reportedly ranks among the top four in the industry.

Keygen Biotech’s cell culture media products are star offerings in the life sciences sector for “import substitution.” The company has established two fully automated intelligent filling production lines tailored to diagnostic reagent systems, with an annual capacity of over 3 million bottles. It has developed a comprehensive solution encompassing cell line construction, customized media development, process development of key biological raw materials, and intelligent manufacturing. Furthermore, Keygen Biotech collaborates with prominent academician teams, including that of Academician Wang Guangji, to jointly tackle key research challenges.

In the field of diagnostic reagents and services, the company has developed a range of innovative diagnostic products focused on maternal and child health, including placental growth factor/soluble fms-like tyrosine kinase-1 (PlGF/sFlt-1), insulin-like growth factor binding protein-3 (IGFBP-3), insulin-like growth factor-1 (IGF-1), and anti-phospholipase A2 receptor antibodies. More than 20 products are currently under development. Notably, in the testing market for conditions such as preeclampsia, its solutions have been deployed in nearly 500 hospital endpoints.

Furthermore, KeyGen Biotech is committed to becoming a catalyst for the clinical translation of scientific research in China’s biopharmaceutical industry. By continuously optimizing its functional layout across the upstream and downstream segments of the biological reagent supply chain, the company has explored and implemented an “open innovation based on shared platforms” business model. To date, KeyGen has established and operated multiple national- and provincial-level technological platforms, facilitating the founding of more than 300 enterprises by high-caliber talents from hospitals, universities, research institutes, and biopharmaceutical companies both in China and abroad.

Under the policy backdrop of the “dual circulation” new development paradigm, accelerating the domestic market launch of scientific and technological research achievements from both home and abroad, and facilitating the translation and application of such research outcomes, has become a call of the times.

The state encourages “mass entrepreneurship and innovation,” and many researchers at hospitals and universities also harbor entrepreneurial dreams. However, the journey from scientific research to clinical application and even to the market is fraught with numerous challenges.

“The market concentration of China’s life sciences industry is not yet high enough. Since innovation is driven by highly skilled talent, the sector urgently needs to accelerate the ‘commercialization of scientific and technological achievements.’ However, scientists and researchers face numerous challenges when starting businesses; possessing core technologies alone is insufficient to bring a product to market. They also require capital, team building, laboratory infrastructure, and market channels, among other resources. We aim to build a shared platform to support them. Clients can leverage our shared laboratories and shared GMP facilities to conduct joint development, product validation, pilot production, and large-scale manufacturing. Some mature products can even enter our sales channels directly to reach customers across China. This reflects our ‘open innovation’ model, which not only helps users reduce operational costs and shorten time-to-market but also enhances our R&D efficiency and continuously enriches our product portfolio. Thus, the ‘shared platform’ enables deeper connections with our clients beyond mere products and services,” said Huang Ying.

NANJING KEYGEN BIOTECH.CO.,LTD. actively promotes "open innovation" by launching collaborative laboratory projects to establish long-term industry-academia-research partnerships with core users nationwide, including hospitals, universities, research institutes, and biopharmaceutical companies. These efforts facilitate comprehensive technical cooperation, talent development, and joint scientific research, thereby accelerating the efficient translation of basic life science research into clinical applications. To date, the company has established laboratory collaborations with 160 university research groups across China, such as those at Nanjing University, Southeast University, and China Pharmaceutical University, as well as with over 60 departments in Grade A tertiary hospitals, including Gulou Hospital, Jiangsu Province Hospital of Chinese Medicine, and the General Hospital of the Eastern Theater Command. In these collaborations, the company provides high-quality research reagents, technical services, and integrated solutions. Looking ahead, the company will continue to expand its product portfolio and service offerings through a strategy of "independent development and controlled manufacturing," introducing more consumables and instruments compatible with its products.

“Traditional biological laboratories are simply combinations of instruments and consumables, with huge maintenance and management costs. What we aim to do is help users integrate laboratory equipment with the Internet of Things (IoT), enabling real-time monitoring and management of laboratories via a mobile app,” said Huang Ying. “Based on our analysis of customer cases, we have developed a data output model tailored to user habits and pain points, aiming to achieve safe laboratory management while reducing costs and improving efficiency. As our customer base continues to expand, the dimensions of our data will be continuously updated, providing our users with an enhanced experience.”

NANJING KEYGEN BIOTECH.CO.,LTD.’s “open innovation” is not only directed at external users but also advocates this unique mechanism for internal talent development.

The biological reagent industry is technology- and talent-intensive, requiring specialized R&D professionals. NANJING KEYGEN BIOTECH.CO.,LTD. provides employees with diversified development platforms and personalized career paths. “We aim to turn Keygen Biotech into a stage for employees’ career growth, enabling more talented individuals with dreams and capabilities to hone their skills here. By building products and projects from scratch into sustainable businesses, they can embark on entrepreneurial journeys within the Keygen platform and realize their life aspirations,” added Huang Ying.

Regarding future plans, Sun Yijun stated that in the short term, the company will develop more product lines around the cellular life sciences sector, expand market channels, enhance customer stickiness, and strengthen NANJING KEYGEN BIOTECH.CO.,LTD.'s position in the field of cell biology, striving to become a leading enterprise in the cellular domain. "Over the past three years, aligning with the characteristics of the post-pandemic era, we have become more focused. As cell-related technologies are NANJING KEYGEN's core competency, cell biology will be our key area of focus in the future."

“After 23 years of accumulation, NANJING KEYGEN BIOTECH.CO.,LTD. has weathered several industry cycles, demonstrating strong risk resilience and sustainability. The company has built a full industrial chain in the life sciences sector based on the ‘products + services + sci-tech innovation carriers’ model, and established a collaborative innovation mechanism and technological service system integrating ‘basic research, medical translation, and innovation and entrepreneurship.’ In the next phase, relying on its three major platforms, Keygen Biotech will further accelerate the aggregation of talent, technology, and products, promote the efficient translation of basic life science research into clinical outcomes, and practice its philosophy of ‘Serving Science, Benefiting Life’ through innovative development,” said Sun Yijun.