Sinovac Biotech Gets Approval To Begin Human Clinical Trials On SIPV Candidate

(RTTNews) - Sinovac Biotech Ltd. (SVA), a provider of biopharmaceutical products in China, announced that it 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 stated that it 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 noted that it 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 track approval by the CFDA as part of the government's polio eradication efforts.

As previously announced, Sinovac has entered into a license agreement with Intravacc (Institute for Translational Vaccinology) from The Netherlands to develop and commercialize the Sabin Inactivated Polio Vaccine (sIPV) for distribution to China and other countries. According to the agreement, Sinovac has committed to commercializing the vaccine in China, inclusive of conducting clinical trials, obtaining regulatory approval, and launching the sIPV vaccine.