CansinoBIO's Td5cp Vaccine for Adolescents and Adults Granted Priority Review by China's Drug Regulator

Stock News05-11

CansinoBIO (06185) announced that the New Drug Application (NDA) for its Adsorbed Acellular Pertussis (Five-Component), Diphtheria, and Tetanus Combined Vaccine for individuals aged 6 and above (Td5cp for adolescents and adults) has been accepted for priority review by the Center for Drug Evaluation of China's National Medical Products Administration. Under China's priority review regulations, the CDE will allocate resources to prioritize the evaluation of NDAs included in this pathway. The Td5cp vaccine for adolescents and adults is indicated for individuals aged 6 and above, serving as a booster for pertussis, diphtheria, and tetanus in this population. While major developed countries have incorporated such vaccines into routine immunization schedules, there is currently no approved pertussis-diphtheria-tetanus booster vaccine for adolescents and adults in China. Therefore, if successfully launched, this product would address an existing gap in the domestic market. The company's Adsorbed Acellular Pertussis (Three-Component), Diphtheria, and Tetanus Combined Vaccine for infants under 2 years old (DT3cP for infants) received NDA approval in April 2026. Compared to the infant DT3cP vaccine, the adolescent and adult Td5cp vaccine includes two additional pertussis antigen components, making it a five-component pertussis-diphtheria-tetanus vaccine. Each pertussis antigen can be purified individually and formulated at a defined ratio, ensuring batch-to-batch consistency and more stable product quality. The company is currently preparing to submit the NDA for the adolescent and adult Td5cp vaccine.

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Under China's priority review regulations, the CDE will allocate resources to prioritize the evaluation of NDAs included in this pathway. The Td5cp vaccine for adolescents and adults is indicated for individuals aged 6 and above, serving as a booster for pertussis, diphtheria, and tetanus in this population. While major developed countries have incorporated such vaccines into routine immunization schedules, there is currently no approved pertussis-diphtheria-tetanus booster vaccine for adolescents and adults in China. Therefore, if successfully launched, this product would address an existing gap in the domestic market. The company's Adsorbed Acellular Pertussis (Three-Component), Diphtheria, and Tetanus Combined Vaccine for infants under 2 years old (DT3cP for infants) received NDA approval in April 2026. 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