TIANJIN, CHINA, December 16, 2019, CanSino Biologics Inc. (“CanSinoBIO”, HK6185) announced today that the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) has granted Priority Review designation to the Company’s NDA for its investigational quadrivalent meningococcal (serogroups A, C, W-135 and Y) conjugate vaccine (MenhyciaTM), according to the latest CDE announcement on its website.
No licensed quadrivalent meningococcal conjugate vaccines are currently available in China and the NDA is the first of its kind to date closest to licensure in the country.
“The Priority Review designation for the NDA is a significant regulatory milestone that underscores the regulators commitment to accelerate approval and subsequent availability of the most needed vaccines such as MenhyciaTM”, said Xuefeng, Yu, Chairman and Chief Exeuctive Officer of CanSinoBIO.
The NDA was accepted by NMPA on the 21st of November, 2019 and the Priority Review designation was officially granted on December 13, 2019 preceded by five working days probational designation for public notice starting on December 6, 2019.
MenhyciaTM is one out of fifteen CanSinoBIO’s core innovative vaccine products under development. It combines four common pathogenic meningococcal serogroups A, C, W135 and Y polysaccharides antigens that are individually conjugated to a carrier protein CRM197. This quadrivelent formulation enables the vaccine to offer long lasting and broader protection. The clincial trial results showed a comparable safety and immunogenicity profile of the candidate administered to three age groups of healthy children from 3 months to 6 years of age.
Both polysaccharide and conjugate vaccines are used for prevention of invasive meningococcal disease caused by Neisseria meningitides, with the latter representing the latest trend in global meningococcal vaccine development due to its better immunogenicity and broader adaptability. Globally, Sanofi Pasteur, GSK and Pfizer are the three manufactuerers and suppliers of quadrivalent meningococcal conjugate vaccines which have been approved for use by 34 countries in their National Immunization Programs (NIPs).
Incorporated in 2009, CanSinoBIO (6185.HK) commits to research, production and commercialization of innovative vaccines for China and global public health security. It possesses four integrated platform technologies including adenovirus-based vectors, conjugation, protein design and recombination and formulation. As of today, it has established a robust pipeline of 15 vaccines covering 12 diseases, including a globally innovative Ebola virus vaccine approved for marketing in 2017.