The US Food and Drug Administration has approved a new drug to treat patients with multidrug-resistant HIV-1, the first therapy in more than a decade with a new mechanism of action. Developed by Taipei, Taiwan–based TaiMed Biologics, Trogarzo (ibalizumab-uiyk) is a humanized monoclonal antibody that binds to the second extracellular domain of CD4 and prevents entry of HIV-1 into CD4+ immune cells. Wuxi Biologics of China, its manufacturer, said that this is also the first FDA approval for a biological drug produced by a Chinese company. Trogarzo is to be used with other HIV medicines as part of an antiretroviral therapy. In August 2017, WuXi Biologics announced that the FDA had completed its pre-license inspection of its facilities in the city of Wuxi, China. Theratechnologies of Canada acquired US rights to market and distribute the drug from TaiMed. In phase 3 trials, Trogarzo used in combination with other antiretrovirals achieved a 70% viral load reduction in a week in over 80% of treatment-experienced, multidrug-resistant patients with HIV-1, and after a 24-week period the viral load of 43% of patients was undetectable. TaiMed Biologics obtained the monoclonal antibody from Genentech in 2007 (Nat. Biotechnol. 32, 508–510, 2014). According to the US Centers for Disease Control and Prevention, approximately 1.1 million people in the US were living with HIV at the end of 2015. Theratechnologies says that 20,000 to 25,000 US citizens with HIV-1 are currently resistant to at least one antiretroviral therapy. Luc Tanguay, president and CEO of Theratechnologies, said in an early March press release that they hope to bring the therapy to patients in the US within 6 weeks at an annual wholesale acquisition cost of $118,000 per year.