WuXi PharmaTech (Cayman) Inc. (NYSE: WX), a leading open-access R&D capability and technology platform company serving the pharmaceutical, biotechnology, and medical device industries with operations in China and the United States, congratulates our partner TaiMed Biologics for receiving breakthrough therapy designation from the U.S. FDA for ibalizumab (TMB355). The FDA designates a drug as a breakthrough therapy if it is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
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.
"We commend our partner TaiMed for this significant regulatory action," said Dr. Ge Li, Chairman and CEO of WuXi PharmaTech. "This is the fourth WuXi-manufactured product to be so designated, reflecting the high quality of the molecules that we choose to work on. We will give TaiMed our full support as they advance this promising product candidate through regulatory review."
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