We are pleased to share with you that our partner, TaiMed Biologics, has received breakthrough therapy designation from the U.S FDA for ibalizumab (TMB355).

Ibalizumab is a humanized monoclonal antibody and a member of an emerging class of HIV therapies known as viral-entry inhibitors.  It is being developed by TaiMed Biologics for the treatment of HIV/AIDS infection.  Clinical-trial supplies of ibalizumab were manufactured at WuXi’s biologics manufacturing facilities. WuXi will work closely with TaiMed in additional clinical-supply manufacture and process validation to assist TaiMed’s anticipated submission of a rolling BLA application. If approved, ibalizumab would be the first biologic product manufactured in China to be launched in the U.S. market.

This is the fourth WuXi-manufactured product to be so designated, reflecting the high quality of the molecules that we choose to work on.

Congratulations to TaiMed Biologics!

 

Related Links:

Congratulations to TaiMed Biologics on Receiving Orphan Drug Designation for Ibalizumab from FDA
FDA Approves Ibalizumab Manufactured by WuXi PharmaTech for Treatment of Patients on Expanded Access