Gilead Submits NDA in China for Lenacapavir, a Twice-Yearly Long-Acting HIV Treatment

On September 28, the CDE official website showed that Gilead Sciences' long-acting HIV drug "Lenacapavir Injection" had been accepted for marketing application in China (acceptance number: JXHS2300090). Earlier on September 23, its tablet formulation was also submitted for marketing application. Lenacapavir is a potential first-in-class capsid inhibitor for the treatment of HIV-1 infection and does not exhibit overlapping resistance with any currently approved antiretroviral therapies (ART).