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CanSinoBIO Submitted NDA/BLA Application for Meningococcal Conjugate Vaccine

January 31, 2019, , CanSino Biologics Inc. (CanSinoBIO) announced that the company submitted a NDA/BLA application for a bivalent meningococcal conjugate vaccine to Center of Drug Evaluation (CDE), a division of National Medicine Product Administration (NMPA) of China.  

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The bivalent meningococcal conjugate vaccine (MCV-AC), with a trade name “Menphecia”, is developed and manufactured by CanSinoBIO for the prevention of diseases associated with group A and group C meningococcal bacterial infections. This vaccine uses CRM197 as the carrier protein, which can reduce the immune interferences caused by potential over use of common carriers in the existing vaccines on the market. The results of Phase III clinical trials showed that Menphecia has very good safety profiles, and the incidence rates of adverse reactions were significantly lower than that of the comparator vaccines in the control groups.

Meningitis is a respiratory infectious disease that commonly occurs among children and adolescents. The main symptoms include high fever, headache, vomiting, and neck stiffness, etc. In severe cases, it can cause septicemia and unrecoverable sequelae. Meningitis is also associated with high mortality rate of 5%~10%.

Vaccination is the most effective way to prevent meningitis. The existing meningococcal vaccines on the Chinese market are mostly meningococcal polysaccharide vaccine (MPV), which has poor immune memory. The newly developed bivalent meningococcal conjugate vaccine (MCV-AC) can be used in infants below 2 years old as a replacement of the polysaccharide vaccine (MPV), when approved by NMPA. The application of the conjugate vaccine is a growing trend in China.

The submission of NDA/BLA application for bivalent meningococcal conjugate vaccine is another important milestone for CanSinoBIO’s product commercialization. Prior to this, CanSinoBIO’s Recombinant Ebola Virus Disease Vaccine (Ad5-EBOV) was approved by NMPA (previously CFDA) in October 2017, which makes CanSinoBIO the only one in Asia, and one of a few biopharmaceutical companies in the world that can develop and produce Ebola vaccine.

CanSino Biologics Inc. (CanSinoBIO) is China’s dynamic biotech leader blazing new paths in R&D, manufacturing, and commercialisation of vaccine products for human use. Beside vaccine products for meningitis and Ebola virus disease prevention, CanSinoBIO are also developing ground-breaking products that are in high demand but lack sufficient supply or quality. These include products such as quadrivalent (ACYW135) meningococcal conjugate vaccine, pneumococcal polysaccharide, and pneumococcal conjugate vaccines as well as a DTcP-based combo and other items.