Gilead Submits NDA for Lenacapavir, a First-in-Class Long-Acting HIV Capsid Inhibitor, in China

On September 23, the CDE website showed that Gilead Sciences' lenacapavir tablets (lenacapavir) marketing application was accepted for the treatment of HIV infection.

Lenacapavir is a first-in-class long-acting HIV capsid inhibitor that inhibits HIV-1 replication by interfering with multiple critical steps in the viral life cycle, including the uptake, assembly, and release of HIV-1 proviral DNA mediated by the viral capsid, as well as the formation of the viral capsid core, with no known cross-resistance to other existing drug classes.

Mechanism of Action of Lenacapavir (Source: N ENGL J MED)

Lenacapavir has been launched in multiple countries including the United States, the European Union, and Japan. It is the only approved HIV treatment drug administered twice a year.

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