CANSINOBIO (06185): The new drug application for Td5cp for adolescents and adults has been accepted.

CANSINOBIO (06185) announced that the New Drug Application (NDA) for its developed adsorbed acellular pertussis-diphtheria-tetanus combined vaccine (for individuals aged 6 and above) (Td5cp for adolescents and adults) has recently received an acceptance notification from the National Medical Products Administration of the People's Republic of China. The Td5cp for adolescents and adults is suitable for individuals aged 6 and above and serves as a booster vaccine for pertussis, diphtheria, and tetanus in this population. Although this vaccine has been incorporated into the regular immunization programs of most developed countries, there is currently no approved booster vaccine for pertussis, diphtheria, and tetanus for adolescents and adults in China. Therefore, if this product successfully enters the market, it will fill the existing gap in the domestic market. The companys DT3cP adsorbed acellular pertussis-diphtheria-tetanus combined vaccine for infants (for those under 2 years old) received NDA approval in April 2026. Td5cp for adolescents and adults includes two additional components of the pertussis antigen compared to the DT3cP for infants, making it a five-component pertussis-diphtheria-tetanus vaccine. Each pertussis antigen can be individually purified and formulated in specific proportions, ensuring batch-to-batch consistency of the product quality, which enhances the stability of the products quality. The Td5cp for adolescents and adults has been included in the priority review by the Center for Drug Evaluation of the National Medical Products Administration of the People's Republic of China.