CanSinoBIO's Adolescent and Adult Pertussis Vaccine NDA Accepted by China's NMPA
核心洞察
CanSino Biologics' New Drug Application for its Td5cp Adolescent and Adult (搜索) combined vaccine was formally accepted by China's NMPA on August 16, 2026.
The five-component booster vaccine targets people aged six years and above and was granted Priority Review status in May 2026.
Reported pertussis (搜索) cases in China exceeded 470,000 in 2024, an approximately 12-fold increase from 2023, underscoring the need for adolescent and adult booster immunization.
CanSino Biologics Inc. (CanSinoBIO) announced on August 16, 2026 that China's National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for its Tetanus, Reduced Diphtheria and Pertussis (搜索) (Acellular, Five Components) Combined Vaccine, Adsorbed, designed for people aged six years and above. The product, referred to as Td5cp Adolescent and Adult (搜索), is being developed as a booster vaccine for adolescents and adults and was granted Priority Review status by the NMPA in May 2026.
The regulatory milestone arrives against the backdrop of a global resurgence in pertussis (搜索), a highly contagious acute respiratory infectious disease caused by Bordetella pertussis. In China, reported pertussis cases exceeded 470,000 in 2024, representing an approximately 12-fold increase compared with 2023. This rise has renewed attention on disease prevention and highlighted the importance of booster immunization during adolescence and adulthood, in addition to primary immunization in infants.
Addressing an Unmet Need in Booster Immunization
Vaccination with diphtheria, tetanus and pertussis (搜索)-containing vaccines is an important measure for preventing the related diseases, yet China has long lacked a dedicated booster immunization product for people aged six years and above. If approved and launched, the Td5cp Adolescent and Adult (搜索) could therefore address an important gap in booster vaccination for this population.
The Td5cp Adolescent and Adult (搜索) contains five pertussis (搜索) antigens, including pertussis toxin (搜索) (PT), filamentous haemagglutinin (FHA), pertactin (PRN), FIM2 (搜索) and FIM3 (搜索). The inclusion of FIM2 and FIM3 differentiates the candidate from the company's three-component DT3cP vaccine, which contains PT, FHA and PRN. According to the company, the individual purification of each pertussis antigen and formulation at defined ratios are intended to support product quality and batch-to-batch consistency.
Building on the Tripecia Approval
The latest development follows the approval in April 2026 of CanSinoBIO's Diphtheria, Tetanus and Pertussis (搜索) (Acellular, Three Components) Combined Vaccine, Adsorbed for infants, Tripecia (搜索) (DT3cP Infant), through the NMPA's Priority Review pathway. That approval marked an important breakthrough for the company in component-based pertussis vaccine technology.
If approved and commercialized, the Td5cp Adolescent and Adult (搜索) is expected to create synergies with Tripecia (搜索), further strengthening CanSinoBIO's pertussis (搜索)-containing vaccine portfolio across different age groups. The continued advancement of this product will also support further exploration of innovative component-based pertussis vaccine technology across broader age groups.
Alignment with Life-Course Immunization Strategy
The company's pipeline expansion comes as China places greater emphasis on life-course immunization. In July 2026, seven government departments, including the National Disease Control and Prevention Administration and the National Development and Reform Commission, jointly issued the 15th Five-Year Plan for Disease Prevention and Control, which explicitly calls for the implementation of a life-course immunization strategy covering the entire population.
From a capital market perspective, the acceptance of the NDA for the Td5cp Adolescent and Adult (搜索) marks the product's formal entry into a key regulatory review stage. It also represents important progress in CanSinoBIO's continued advancement of innovative vaccine R&D and commercialization, while strengthening market expectations for the development of the company's pipeline of combination vaccine candidates and laying a foundation for the company's medium- to long-term performance growth.