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CanSinoBio Submitted Clinical Trial Application of 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine(CRM197,TT)to NMPA

On Jan. 2, 2019, CanSino Biologics Inc. announces that the company submitted the clinical trial application of 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine(with CRM197 and TT carrier proteins) to Chinese national regulatory authorities NMPA on Dec 29, 2018. The 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (short named as PCV13i) has been independently developed by CanSino Biologics Inc. with its own intellectual property rights.


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In comparison with imported PCV13 vaccine product and other similar vaccine candidates under development in China, CanSinoBio uses two types of carrier proteins, including recombinant cross-reacting material 197 (CRM197) and tetanus toxoid (TT) in its PCV13i vaccine. This could reduce the potential negative effects caused by using excessive single carrier protein. During the manufacturing processes, no animal source components are used, which reduces the potential risks from adventitious biological materials.  In addition, advanced process technologies are developed by CanSinoBio to purify polysaccharides, which helps to avoid the phenolic residues caused by purification methods currently used in industry.


CanSinoBio had in depth communications with CDE of NMPA prior to submitting this CTA application. According to the Announcement on the Adjustment of the Procedures for the Review and Approval of Drug Clinical Trials (No. 50 of 2018), within 60 days from the date of acceptance of the application, if no negative or doubtful opinion has been received from CDE, the sponsor can start the clinical trial in accordance with the submitted protocols. Under the active reform of NMPA and the optimization of the drug review procedures, the vaccine candidate PCV13i is expected to enter the clinical trial stage soon.


Pneumococcal disease is one of the most serious public health problems around the world. The goal of “Eliminating preventable child deaths caused by pneumonia by 2025” has been set out in Global Action Plan Pneumonia (GAPP) by WHO. Comprehensive inoculation of pneumococcal polysaccharide conjugate vaccine is the main method to achieve this goal. At present time, the 23-valent pneumococcal polysaccharide vaccines (PPV23) that have been produced domestically cannot protect children under 2-years old from Pneumococcal disease. Because the 2-years old children are among the highest incidence population groups with pneumococcal diseases, the best way to prevent pneumococcal disease in children is to inoculate pneumococcal polysaccharide conjugate vaccine. The rapid development and registration of CanSinoBio’s PCV13i candidate vaccine will bring high quality and affordable infant pneumococcal vaccine into China and benefit the children in China.