QuaCell Biotechnology Files IPO Prospectus, Empowering Biopharma Innovation Through Advanced Cell Culture Technologies

As domestic antibody drugs enter the industrialization phase, the surge in industrialization activities has simultaneously driven demand for outsourced research and production services, such as CROs, CDMOs, and CMC. With China’s technical standards and quality systems increasingly aligning with international norms, coupled with the inherent cost advantages in infrastructure and human resources offered by domestic outsourcing providers like CDMOs, the global industrial chain for outsourced research and production services is gradually shifting to China, with this trend accelerating.

However, such rapid industrial development has exposed a significant gap in the supply of core upstream raw materials. Due to a late start and weak foundational capabilities, many critical materials remain dependent on imports, and process optimization lags behind. There is an urgent need for domestically produced alternatives in the upstream biopharmaceutical supply chain to rapidly catch up.

Among upstream core raw materials, cell culture media are hailed as the “chips” of biopharmaceuticals, underscoring their indispensable importance. The quality and performance of culture media, along with process sophistication, directly impact the ultimate translation of outcomes across the entire biopharmaceutical industry chain. As such a critical core raw material, cell culture media face robust demand and a substantial production capacity gap. Furthermore, for leading enterprises engaged in innovative drug R&D, the development of customized media processes tailored to different technological pathways requires even greater professional product and technical support.

The three founders of Kangsheng Biologics (from left: Dr. Yuan Jun, CTO; Dr. Pan Honghui, CEO; Mr. Wu Fan, COO)

Against this backdrop, in 2018, Dr. Yuan Jun, together with two other partners, Dr. Pan Honghui and Mr. Wu Fan, co-founded Zhongshan Kangtian Shenghe Biotechnology Co., Ltd. (QuaCell Biotechnology, hereinafter referred to as “Kangsheng Biotech”) in Zhongshan, within the Guangdong-Hong Kong-Macao Greater Bay Area. The company specializes in products and CXO services related to large-scale industrial cell culture applications. Dr. Yuan Jun, a graduate of École Centrale de Lyon in France, boasts over ten years of experience in the biopharmaceutical industry. He previously served as R&D Director at Hisun Pharmaceutical, where he participated in the development of several major project platforms. Currently, he serves as Chief Technology Officer (CTO) of Kangsheng Biotech, overseeing upstream technology research and development, production management, and related operations.

“The selection of host cell line platforms is critical to biopharmaceutical companies. In China, the pace of target development in the biopharmaceutical industry is rapid; however, companies either rely on purchasing commercialized host cell line platforms from abroad, which imposes a substantial cost burden on domestic start-up biopharmaceutical enterprises, or use platforms that lack complete traceability documentation, thereby posing future risks for their Investigational New Drug (IND) applications and subsequent drug commercialization,” stated Dr. Yuan Jun.

Since the company’s inception, Dr. Yuan Jun swiftly initiated projects and embarked on the development of host cell line platform systems. With over a decade of experience in the biopharmaceutical industry, Dr. Yuan has established multiple gene expression platforms for prokaryotic and eukaryotic organisms (Yeast, CHO), and possesses extensive expertise in techniques such as cell culture adaptation, gene editing, and homologous recombination. Leveraging the substantial technical expertise accumulated by Dr. Yuan and his team over many years, the company rapidly launched Quacell® CHO-K1Q System, China’s first commercialized host cell line platform. To date, this platform has been licensed and utilized by dozens of enterprises both domestically and internationally, and projects utilizing this platform have received acceptance from China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA).

“Formula research, development, and manufacturing of cell culture media are among the key core competencies of Kangsheng Biologics. Cell culture media have a crucial impact on the production efficiency, yield, and quality of pharmaceutical products,” stated Dr. Yuan Jun. Dr. Pan Honghui, co-founder of Kangsheng Biologics, previously worked at Merck Sigma and Hisun Pharmaceutical, accumulating extensive experience in formula research and development. Leveraging this expertise, we have developed a high-throughput screening system for culture media formulations, accelerating the iteration of our platform’s media products and the development of customized formulas for clients.

“In addition to capabilities in culture medium formulation development, project development experience is also critical. For instance, we have found that timely management of cellular metabolites in the culture medium is one of the key factors in enhancing the final yield of drug products and also impacts their ultimate quality,” stated Dr. Yuan Jun. He noted that through innovative technologies and exceptional product R&D capabilities, Kengseng Bio can provide biopharmaceutical and biotechnology companies with highly professional and efficient cell culture processes and services, eliminating interference from cellular metabolites in culture media and thereby facilitating clients’ pharmaceutical R&D efforts. Currently, its project development services are applied to culture medium solutions for multiple clients’ preclinical and clinical-stage projects.

Dr. Yuan Jun emphasized, “Kangsheng Biologics is the first company in China to possess both a commercial host cell line development system and its corresponding platform media. One of the core R&D initiatives undertaken by our team over the past two years has been the continuous optimization and iteration of these two systems, achieving their more seamless integration to provide customers with a more efficient and convenient cell line development system and platform media.”

With continuous technological accumulation, Kangsheng Biologics has gradually expanded its business chain into the CRO and CDMO outsourcing service sectors, establishing a core business framework comprising cell line development, serum-free media customization, and CDMO services. In just over three years, Kangsheng has not only developed multiple media formulations but also provided process development and optimization services for more than 40 antibody protein drug projects, while deeply engaging in various phased clinical trial projects.

Currently, Kangsheng Biotech is engaged in deep collaborations with nearly 100 biopharmaceutical and biotechnology enterprises in China. Adhering to quality regulatory standards such as ISO and GMP, the company is dedicated to the research and manufacturing of cell culture media, providing critical raw materials to global biopharmaceutical and gene therapy companies. Focusing on customer requirements, it offers integrated services from DNA to GMP production that comply with FDA and NMPA regulations.

Meanwhile, to meet the rapidly growing demands of users in the biopharmaceutical industry, Kangsheng Biotech has been continuously increasing its investment in capacity expansion. Building upon its existing 10,000-square-meter Zhongshan production base for culture media and CDMO services located in the heart of the Guangdong-Hong Kong-Macao Greater Bay Area, the company has launched Phase II of its project in Suzhou Industrial Park. Upon completion, this project will increase production capacity by several dozen times, aiming to provide a robust guarantee of supply for biopharmaceutical enterprises.

Rapidly expanding Kangsheng Biotech, leveraging its exceptional founding team, solid operational foundation, and the promising prospects of benchmarking against high-quality industry sectors, has secured multiple rounds of strategic investment from renowned venture capital firms—including Shenzhen Capital Group and Queshan Investment—since its inception. The company has also been honored with numerous accolades, such as “Pearl River Entrepreneurial Talent Enterprise,” one of the “Top 50 Potential Enterprises” in the Guangdong-Hong Kong-Macao Greater Bay Area, and “Asia’s Most Promising Leading Enterprise.”

“Riding the wind and cleaving the waves,” with the booming development of the biopharmaceutical industry and the surging tide of domestic substitution, Kangsheng Biologics will continue to take customer needs as its responsibility and industry development as its blueprint. It will consistently provide high-quality products and services in the field of cell culture to biopharmaceutical users in China and around the world, empowering medical innovation and accelerating industrial progress!