Sinovac gets approval to begin clinical trials on Sabin Inactivated Polio Vaccine candidate

Dec 10 2015

Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, 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 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.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "As an inactivated polio vaccine different from conventional Salk-IPV, the clinical trial approval of our sIPV vaccine candidate represents a significant achievement. As we progress closer to commercialization, this vaccine is expected to open up additional opportunities in China's public market and also introduce overseas expansion opportunities by potential purchasing programs from international organizations. While national governments collaborate to promote IPV under the WHO's Polio Eradication & Endgame Strategic Plan, the world still faces limited production capability. With Sinovac's fully integrated vaccine capabilities and our commitment to providing children around the world with our vaccines, we are dedicated to making efforts for polio eradication both in China and around the world. In addition, the vaccine also contributes to our pipeline products portfolio diversification by providing us the opportunity to develop sIPV related combo vaccine in the future."