Tripecia® was granted NDA approval by the NMPA in April 2026. As the first approved adsorbed diphtheria, tetanus and pertussis (acellular, three component) combined vaccine in China¹, Tripecia® not only contains pertussis toxin (PT) antigen and filamentous hemagglutinin (FHA) antigen but also the key antigen pertactin (PRN), providing more comprehensive protection². Results from a large-scale Phase III clinical trial demonstrated that Tripecia® elicits a more potent immune response, achieving superior primary immunogenicity for PT compared to the control group¹. Furthermore, it does not contain thimerosal, antibiotics, or animal-derived components. The incidence of fever after the booster dose was reduced by over 50%, indicating a favorable safety and tolerability profile³.

CanSinoBIO’s independent breakthrough in component purification technology filled a gap in this field for domestic companies. The vaccine was granted priority review status by the Center for Drug Evaluation (CDE) of the National Medical Products Administration in February 2025, and subsequently obtained NDA approval from the NMPA in April 2026. The successful approval of Tripecia® marks another significant milestone in CanSinoBIO’s innovation-driven vaccine development.

References:

1.          Zhang W, Wei C, Wan P, et al. Safety and immunogenicity of diphtheria, tetanus and pertussis (acellular, three components) combined vaccine, adsorbed after three-dose priming in 2 months age infants: a randomized, blinded, controlled phase III clinical trial in China. Emerg Microbes Infect. 2026 Dec;15(1):2625556.

2.          Dai H, Sui X, Che J, et al. Pathogenicity and vaccine protection of circulating pertactin- and filamentous hemagglutinin-deficient Bordetella pertussis strains. Emerg Microbes Infect. 2026 Dec;15(1):2640283.

3.          CSR data on file