We are pleased to announce that the U.S. Food and Drug Administration has completed the Pre-License Inspection (PLI) of WuXi Biologics cGMP manufacturing facilities for production of TMB-355 (ibalizumab) with no critical findings. The five-inspector 13-day inspection covered both drug substance and drug product facilities in the city of Wuxi, China. WuXi Biologics is expected to complete all follow-up actions within three months, which should not impact the BLA review timeline of ibalizumab.
This is first such inspection in China. Ibalizumab is a humanized monoclonal antibody being developed for the treatment of Multiple Drug Resistant Human Immunodeficiency Virus-1 (MDR HIV-1) infection. If ibalizumab is approved, the inspected facilities will be the first cGMP biologics manufacturing facilities in China approved by the U.S. FDA for commercial biologics products, marking yet another milestone that WuXi Biologics has set in China. This pending U.S. FDA approval continues to reinforce the strong commitment to quality WuXi Biologics has made to its global client base.