Tianjin, 7 February 2025 - CanSino Biologics Inc (“CanSinoBIO” or “the Company”) is pleased to announce that the Center for Drug Evaluation, National Medical Products Administration of the People’s Republic of China (the “NMPA”) has granted priority review status to the Company’s new drug application (the “NDA”) for its absorbed diphtheria, tetanus, and acellular pertussis (components) combined vaccine (the “DTcP”) for infants (below 2 years old) (the “DTcP Infant”).
This announcement follows the Company’s prior notification on December 16, 2024, regarding the acceptance of the NDA by the NMPA. The DTcP Infant is a potential best-in-class DTcP vaccine for infants in China. As a diphtheria, tetanus and acellular pertussis (components) vaccine, each pertussis antigen of the DTcP Infant can be purified separately and formulated in a defined ratio, thus ensuring batch-to-batch consistency of product quality and making the product more stable. Our DTcP Infant is positioned as a viable alternative to imported vaccines in China. Furthermore, the development of DTcP Infant establishes a solid foundation for the further development of our Tdcp Adolescent and Adult, as well as DTcP components combined vaccine.
Granting priority review status to the Company’s DTcP Infant signifies the importance of this vaccine candidate and the urgent need of its expedited assessment. This recognition from the Center for Drug Evaluation, NMPA underscores the Company’s commitment to developing innovative vaccines that meet the highest standards of safety and efficacy.
CanSinoBIO is devoted to advancing the field of vaccine development and aims to deliver innovative, high-quality, and affordable vaccines worldwide. The Company is committed to enhancing global public health and addressing critical public health challenges on a global scale.