Sinovac Receives Clinical Trial Approval for Sabin-IPV Candidate

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Sinovac Biotech Ltd.
SVA
today announced that the Company has obtained approval to begin human clinical trials on its Sabin Inactivated Polio Vaccine (or "sIPV") candidate. In preparation of beginning human clinical trials, Sinovac is currently finalizing the clinical trial protocol based on the clinical trial license. The Company plans to start the clinical trials in the first half of 2016 and expects to complete these trials by 2018. According to the approval, Sinovac will conduct human clinical trials to select the dosage and evaluate safety and immunogenicity of the vaccine candidate. The Company will use conventional Salk-IPV and Sabin-IPV on the market as control groups in the clinical trials. The Company will also evaluate the manufacturing consistency of three lots in the trials. The Company plans to build a new commercial production facility of sIPV in an existing building at the Company's Changping site. The plant will have a designed annual capacity of ten million doses. The construction is expected to begin in 2016. The clinical trial application for the sIPV was officially accepted by the China Food and Drug Administration (CFDA) in October 2014 and received fast
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