CanSino Biologics Inc. announced that the New Drug Application (NDA) for its Tetanus, Reduced Diphtheria, and Pertussis (Acellular, Five Components) Combined Vaccine, Adsorbed, has been accepted by China's National Medical Products Administration. This vaccine, known as the Td5cp Adolescent and Adult, is designed as a booster for individuals aged six years and above and was granted Priority Review status in May 2026.
The acceptance of the NDA signifies a crucial step in CanSinoBIO's efforts to expand its pertussis-containing vaccine portfolio. If approved, the Td5cp Adolescent and Adult vaccine is expected to complement CanSinoBIO's recently approved next-generation three-component DTaP vaccine, Tripecia, further strengthening the company's position in the vaccine market across various age groups.
Pertussis, a highly contagious respiratory disease, has seen a resurgence globally, with reported cases in China exceeding 470,000 in 2024. This represents a significant increase compared to the previous year, highlighting the growing importance of booster immunization during adolescence and adulthood. Despite the rising cases, China has lacked a dedicated booster immunization product for those aged six and above until now.
CanSinoBIO's Tripecia, a Diphtheria, Tetanus, and Pertussis (Acellular, Three Components) Combined Vaccine for infants, was approved for marketing earlier this year. The Td5cp Adolescent and Adult vaccine builds on this success by including two additional pertussis antigens, FIM2 and FIM3, ensuring stable product quality and consistency.
The advancement of the Td5cp Adolescent and Adult vaccine aligns with China's “15th Five-Year Plan for Disease Prevention and Control,” which emphasizes a life-course immunization strategy. This plan aims to provide comprehensive immunization protection for all age groups, supporting the development of innovative vaccine solutions.
From a business perspective, the acceptance of the NDA for the Td5cp Adolescent and Adult vaccine marks an important milestone in CanSinoBIO's vaccine research and development efforts. It also strengthens market expectations for the company's pipeline of combination vaccine candidates and lays the groundwork for medium- to long-term performance growth.
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