Nasdaq-listed Sinovac gets China FDA nod for Sabin polio trials

Nasdaq-listed vaccinemaker Sinovac Biotech ($SVA) won a China FDA nod for human clinical trials of its Sabin inactivated polio vaccine (SIPV) candidate, with a formal start expected in the first half of 2016. The company made the trial application in October 2014. The Beijing-based firm licensed the vaccine from Intravac (Institute for Translational Vaccinology) of the Netherlands. "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," according to a release. Plans include building new commercial production facility at its Changping facility in China, with an annual capacity of 10 million doses. The construction is expected to begin in 2016. "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," Weidong Yin, chairman, president and CEO of Sinovac, said in a statement. Release

 

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