Tetcia® was granted NDA approval by the NMPA in August 2026, providing a new option for active immunization against tetanus for adults in China, with a stronger immune response and more durable protection.

Tetcia® is manufactured using an animal component-free culture medium fermentation process, which helps control the risk of exogenous sensitization at the source while ensuring a stable and well-controlled process at commercial scale. Results from a large-scale Phase III clinical study demonstrated a more potent immune response following vaccination with Tetcia®. At 30 days post-vaccination, the antibody geometric mean concentration (GMC), seropositivity rate, and seroconversion rate all reached high levels. In particular, the antibody GMC was superior to that of the control group, reaching 1.3 times the level observed in the control group. Among participants aged 18–45 years receiving a booster dose, the GMC was 86% higher versus controls, demonstrating a more pronounced immunological advantage. Tetcia® also demonstrated durable protection, with an antibody seroconversion rate of 98.25% at six months post-vaccination, remaining essentially consistent with the level observed at 30 days post-vaccination.

The approval of Tetcia® marks another important milestone for CanSinoBIO in its long-term commitment to bacterial vaccine R&D. It further expands the Company’s commercial product portfolio and helps provide targeted active immunization for people across different age groups.