WuXi Biologics’ partner, TaiMed Biologics, has received approval from the U.S. FDA for Trogarzo (ibalizumab) for the treatment of adult patients living with HIV who have tried multiple HIV medications in the past and whose HIV infections cannot be successfully treated with other currently available therapies.

Fewer than 10 global CDMOs have so far obtained approval from the U.S. FDA for biological products. Trogarzo’s approval makes WuXi Biologics among the world’s top 10, and the only Chinese company approved by the U.S. FDA. 

Jeff Murray, M.D., deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said, “While most patients living with HIV can be successfully treated using a combination of two or more antiretroviral drugs, a small percentage of patients who have taken many HIV drugs in the past have multidrug resistant HIV, limiting their treatment options and putting them at a high risk of HIV-related complications and progression to death. Trogarzo is the first drug in a new class of antiretroviral medications that can provide significant benefit to patients who have run out of HIV treatment options. New treatment options may be able to improve their outcomes.”

“We congratulate TaiMed on achieving this significant milestone. As its long-term partner, we are pleased to contribute to bringing this innovative biologics to HIV patients globally,” said Dr. Chris Chen, chief executive officer of WuXi Biologics. “This approval validates our premier global quality standards in cGMP manufacturing and our pioneering business strategy of adopting single-use technology for commercial manufacturing, which sets solid foundations for WuXi Biologics to significantly expand our commercial manufacturing capacity to support global clients.”