Kangtai bio's pentavalent vaccine enters phase III trials

Shenzhen Kangtai Biological Products Co., Ltd. announced its wholly-owned subsidiary, Beijing Minhai Biotechnology Co., Ltd., has officially commenced Phase III clinical trials for its adsorbed acellular diphtheria, tetanus, pertussis (DTaP), inactivated polio (IPV), and *Haemophilus influenzae* type b (Hib) conjugate vaccine (pentavalent vaccine). The first subject was successfully enrolled today. This vaccine is designed to prevent diphtheria, tetanus, pertussis, poliomyelitis, and invasive infections caused by *Haemophilus influenzae* type b, offering the advantage of reducing the number of injections required for infants.

The Phase III trial will use a randomized, blinded, positive-controlled design to evaluate the vaccine's safety and immunogenicity in healthy individuals aged two months and older. Currently, the domestic market for pentavalent vaccines is exclusively supplied by an imported product from Sanofi Pasteur.

Kangtai Bio emphasizes that the successful commencement of this Phase III trial represents a significant milestone. If approved, the vaccine could break the existing import monopoly and strengthen the company's product portfolio in the multi-valent vaccine sector, while also laying a foundation for the development of hexavalent and other multi-valent vaccines. However, the company also cautioned that vaccine development involves inherent risks, including uncertainties regarding clinical trial progress, results, and market approval timelines.