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CanSinoBIO Announces NMPA Acceptance for Its New Drug Application for Investigational Quadrivalent Meningococcal Vaccine

TIANJIN, CHINA, November 22th, 2019, CanSino Biologics Inc. (“CanSinoBIO”, HK6185) announced today that China National Medical Products Administration (NMPA) has accepted Company’s New Drug Application (NDA) for its investigational quadrivalent meningococcal (serogroups A, C, W-135 and Y) conjugate vaccine, MenhyciaTM by registered trade name.

 

No licensed quadrivalent meningococcal conjugate vaccines are available to date in China, making the NDA for MenhyciaTM most likely the first of its kind ever closest to licensure in the country.

 

“NMPA’s acceptance of the NDA reflects our efforts to make this innovative and most needed vaccine candidate quickly available in China for improved protection of those at higher risks of meningitis”, said Xuefeng Yu, Chairman and Chief Executive Officer of CanSinoBIO.

 

The NDA was submitted to NMPA on November 14, 2019 preceded by a Pre-NDA submission in July. Earlier in February this year, NMPA had also accepted for review of the Company’s NDA for an investigational bivalent (serogroups A and C) meningococcal conjugate vaccine. With the two vaccines in portfolio, CanSinoBIO expects to be able to respond to the tiered market needs in China.

 

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 clinical trial results showed a comparable safety and immunogenicity profile of the candidate administered to three age groups of healthy children from 2 months to 6 years of age.

 

About CanSinoBIO

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.