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Progress of Quadrivalent Influenza Vaccine of Hualan Bio

Progress of Quadrivalent Influenza Vaccine of Hualan Bio

The Quadrivalent Influenza Vaccine developed by Hualan Biological Bacterin Co., Ltd. applied for clinical trial in July 2013; obtained the approval document of drug clinical trial in April 2015; declared the  production number in July 2017; accepted the On-site Inspection of Drug Registration in April 2018. During the inspection, six batches of Quadrivalent Influenza Vaccine samples were selected and sent to National Institutes for Food and Drug Control.

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Recently, Hualan Bio has obtained the Qualification Test Report of Quadrivalent Influenza Vaccine samples. According to the drug registration procedures, the above documents will be summarized to the Center for Drug Evaluation, CFDA for comprehensive review. CFDA will issue the production number after qualified evaluation, and the Quadrivalent Influenza Vaccine is expected to be on the market in 2018. At the same time, the Influenza Vaccine (Split, Virion), Quadrivalent developed by Hualan Bio which is suitable for children aged from 6 to 35 months has already applied for the production number and under review by Center for Drug Evaluation, CFDA currently.

TAG:  Quadrivalent Influenza Vaccine, Hualan Bio, CFDA, Influenza Pandemic