Hong Kong-listed Concierto Biologics issued a notice that the company submitted a conditional listing application for the New Guan Pneumonia vaccine to China’s State Drug Administration on Feb. 21, and the application has been accepted.
Hong Kong-listed Concierto Biologics issued a notice on Wednesday (24), stating that the company submitted a conditional marketing application for the New Guan Pneumonia vaccine to the State Drug Administration of China on Feb. 21 and the application has been accepted. The vaccine, which was developed in cooperation with the Institute of Biological Engineering of the Institute of Military Medical Research of the Chinese Communist Party‘s military academy of sciences, has an overall efficacy of 65.28 percent protection against all symptoms on 28 days after one injection, the notice noted.
Two vaccines have already been approved for conditional marketing in mainland China, including those by Sinopharm China Biologicals and Kexin, both of which are inactivated vaccines. If Concierge Biologics is finally approved, it will be the third vaccine for the new pneumonia crown to be conditionally marketed in mainland China. The vaccine differs from the other two in that it requires only one dose.
According to an earlier report by Pengpai News, the vaccine was developed jointly with Chen Wei’s team at the Institute of Biological Engineering, Institute of Military Medical Research, PLA Academy of Military Sciences, and its trade name has been confirmed as “Kvisa”.
In the announcement, Concierge Biologics said that the vaccine has completed the vaccination and interim data analysis of more than 40,000 subjects in the global multicenter phase III clinical study in five countries, including Pakistan, Mexico, Ross, Chile and Argentina, and the results of the interim analysis of the phase III clinical trial showed that the overall protection efficacy of the vaccine against all symptoms was 65.28% on the 28th day after vaccination, and for severe symptoms, the protection efficacy of the vaccine was 65.28% on the 14th day after vaccination. The efficacy of the vaccine was 68.83% after 14 days of vaccination and 90.07% after 28 days of vaccination.
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