Ibalizumab regulatory update

TaiMed and manufacturing partner WuXi PharmaTech Inc. (NYSE:WX, Shanghai, China) said FDA approved a batch of an IV formulation of TaiMed's ibalizumab for use under an IND - the first reported biologic manufactured in China to receive clearance from the agency for U.S. use, according to the partners. FDA said under federal law it cannot confirm if this is the first biologic manufactured in China to receive IND clearance.

TaiMed has exclusive, worldwide rights to develop and commercialize ibalizumab from Roche's Genentech unit, which gained the compound through its 2007 acquisition of Tanox Inc. TaiMed has been using ibalizumab manufactured before the company in-licensed the compound. In 2012, TaiMed partnered with WuXi to manufacture more product for Phase II and III trials (see BioCentury, Sept. 24, 2007). ...