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CanSinoBIO’s Protein-based Pneumococcal Vaccine Candidate Received Clinical Approval from Chinese Regulatory Agency NMPA

Oct 31, 2018, CanSino Biologics Inc. announced that the company’s innovative vaccine candidate “Protein-based Pneumococcal Vaccine” (PBPV) obtained approval for clinical trials from the Center for Drug Evaluation (CDE) of National Medical Product Agency (NMPA) in China. This is CanSinoBIO’s third globally innovative vaccine candidate that has moved into the clinical trial stage. The other two are Ebola virus disease vaccine (Ad5-EBOV) which was approved by NMPA of China as a new drug for emergency use and stockpile, the TB Booster vaccine which is currently in phase Ib clinical trial in Canada.


The PBPV is a third-generation pneumococcal vaccine. Compared with the first generation of pneumococcal polysaccharide vaccine (PCV23) and the second generation of pneumococcal polysaccharide conjugate vaccine ( PCV13), PBPV has unique advantages such as serotype-independent, broader coverage and easy to scale up.  Pneumococci containmore than 90 serotypes. CanSinoBIO’s PBPV vaccine candidate uses several proteins as antigen components, which provide protection independent to the serotypes of pneumococcal bacteria. PBPV is able to stimulate both humoral and cellular immune responses and could be suitable for both infants and the elderly.The production process is expected to have good quality control and can be further scaled up. Protein-based pneumococcal vaccine has been important research direction for global vaccine industry.Several scientific publications have indicated that protein antigen based pneumococcal vaccine candidates showed good potential in term of product safety and immunogenicity.


Streptococcus pneumoniae is gram-positive, diplococcus with capsule. Pneumococcal infections can cause meningitis, bacteremia, pneumonia, otitis media and other serious diseases. According to WHO report, pneumococcal infection leads to approximately 476,000 deaths globally each year. The incidence rates of pneumococcal diseases in developing countries are much higher than that in industrialized countries. The infants and the elderly are the main target of Streptococcus pneumoniae. WHO recommends the inclusion of PCVs in childhood immunization programs worldwide. In particular, countries with high childhood mortality should make the introduction of these multicomponent PCVs a high priority. The market potential for pneumococcal vaccines is enormous. Once CanSino’s newly developed PBPV candidate succeeds, it can make great contributions to the prevention of pneumococcal infections. 


About CanSinoBIO

CANSINOBIOLOGICS INC. (CanSinoBIO) is China’s dynamic biotech leader blazing new paths in R&D, manufacturing and commercialisation of vaccine products for human use. Founded in the Tianjin Economic and Technological Development Area (TEDA)in 2009, CanSinoBIO’s founders formed a superb team of scientists and managers who had previously held senior management and technical positions at many of the world’s leading pharmaceutical companies. Equipped with the latest cutting-edge scientific know-how and technology, CanSinoBio has established a robust vaccine pipeline, and is one of the leading vaccine companies in China.