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CanSinoBIO receives approval for its 13-valent penumococcal conjugate vaccine to start clinical trials

April 19, 2019, CanSino Biologics Inc. (CanSinoBIO, 6185.HK) announces that it received the National Medical Products Administration’s (NMPA) permission for its PCV13i, a candidate 13-valent pneumococcal conjugate vaccine, by to start human clinical trials.

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This is the second approval CanSinoBIO has been granted as of today for clinical trials of its novel pneumococcal vaccines, showcasing another step forward in the company’s commercialization commitment. A novel protein-based pneumococcal vaccine (PBPV) candidate was approved for clinical trials in October 2018.


PCV13i is the company’s proprietary vaccine candidate under development for protection against invasive pneumococcal disease (IPD). It contains capsular polysaccharides from 13 pneumococcal serotypes that are responsible for over 80% of the IPD among children under five years of age in China, according to Expert Consensus on Immunization for Prevention of Pneumococcal Disease in China published in 2017.

Each of these antigens are individually conjugated to one of the two carrier proteins, CRM197, a non-toxic variant of diphtheria toxin, and a tetanus toxoid (TT), which make PCV13i unique to other pneumococcal conjugate vaccines currently available and under development in China. Using two carrier proteins will minimize the potential negative effects caused by using excessive single carrier protein.

Pneumococcal infections remain a leading cause of mortality and morbidity among children under five globally. WHO reported an estimated death of 460,000 children under five in 2008, with infants under two contributing disproportionately to the pneumococcal death.

Incorporated in 2009, CanSinoBIO commits to research, production and commercialization of innovative vaccines for global public health security including China. It possesses four integrated platform technologies including adenovirus-based vectors, conjugation, protein design and recombination and formulation. As of today, CanSinoBIO has a pipeline of 15 innovative vaccines covering 12 diseases, including a globally innovative Ebola virus vaccine approved for marketing in 2017. CanSinoBIO is a listed company on the Main Board of HKEx (6185.HK).