CanSino Biologics Inc., (HKG: 6185), a leading Chinese biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its CRM197, a 13-valent pneumococcal polysaccharide conjugate vaccine (TT vector). This development marks a significant step forward in the advancement of pneumococcal vaccination options in China.
The vaccine, designated as PCV13i, utilizes a dual-vector technology that enables the covalent binding of polysaccharide antigens to protein carriers. This innovative approach allows the polysaccharide to be transformed into a T cell-dependent antigen once it is linked to the carrier protein. The result is a vaccine capable of inducing a more robust and specific antibody response in infants and children under two years old, as well as generating memory B cells that contribute to long-term immune memory.
Moreover, the dual-vector technology is designed to mitigate immunosuppression that may occur when PCV13i is administered concurrently with other vaccines, due to its reduced immunogenicity. This feature is particularly important in the context of combined vaccination schedules, where the potential for interference between vaccines is a consideration.
The acceptance of the NDA filing by the NMPA is a promising development for CanSino Biologics, indicating that the regulatory process for this potentially game-changing vaccine is underway.- Flcube.com
