Shenzhen Kangtai Biological Products Co., Ltd. (SHE: 300601) announced today that the China National Medical Products Administration (NMPA) has granted approval for its Sabin‑Strain Inactivated Poliomyelitis Vaccine (Vero Cell). The vaccine, developed on a Vero‑cell platform, is designed to prevent acute infectious disease caused by all three serotypes of the poliovirus.
How the Vaccine Works
- Sabin‑Strain Basis – The vaccine contains inactivated Sabin strains of poliovirus types I, II, and III.
- Immune Response – Upon intramuscular injection, the immune system mounts a robust antibody response, conferring protective immunity against wild‑type poliovirus infection.
- Safety Profile – As an inactivated formulation, it eliminates the risk of vaccine‑derived poliomyelitis, making it suitable for widespread immunization campaigns.
Market Landscape
Kangtai is not the only Chinese manufacturer to offer a Sabin‑strain inactivated vaccine. Beijing Sinovac Biotech Ltd., Beijing Institute of Biological Products Co., Ltd., and the Institute of Medical Biology, Chinese Academy of Medical Sciences have already launched similar products. The approval positions Kangtai to compete in a growing global poliovirus vaccine market, projected to reach $1.2 billion by 2030.
Regulatory and Commercial Implications
- NMPA Clearance – The approval enables Kangtai to market the vaccine domestically and pursue export licensing.
- Strategic Partnerships – Kangtai plans to collaborate with WHO and UNICEF for global immunization initiatives, potentially securing sizable procurement contracts.
- Pipeline Synergies – The company’s existing expertise in Vero‑cell vaccine platforms will accelerate development of other inactivated viral vaccines.
Outlook
With the NMPA clearance secured, Shenzhen Kangtai is poised to enhance its portfolio of inactivated vaccines and support China’s goal of achieving polio eradication. The company’s next steps include scaling up production capacity and initiating clinical studies for broader immunization schedules.-Fineline Info & Tech
