FDA approves WuXi’s manufacture of ibalizumab in China for use under a U.S. IND
The FDA has approved the first batch of the ibalizumab (TMB-355) drug substance and sterile drug product, manufactured at WuXi PharmaTech's biologics facilities and developed by TaiMed Biologics for the treatment of HIV/AIDS infection.
This is the first reported FDA approval of a sterile biologics product manufactured in China for use under a U.S. IND. WuXi sais it marks an important milestone in its investment to expedite global development of innovative biologics.
WuXi is a pharmaceutical, biotechnology and medical device R&D services company, with operations in China and the U.S. TaiMed Biologics is a publicly held Taiwanese biotechnology company. Ibalizumab is a humanized monoclonal antibody and a member of an emerging class of HIV therapies known as viral-entry inhibitors.