What’s the latest news about Napavir/Salanka?

Lenapavir sodium/Sunlenca (Sunlenca) is a new antiHIV drug, which is an HIV-1 capsid inhibitor. The drug was developed by Gilead Sciences and was approved in the United States in 2022 for the treatment of drug-resistant HIV (AIDS) infections. In June 2024, the FDA approved its indication as a preventive drug, becoming the world's first HIV preventive drug to be injected every six months. In January 2025, lenapavir sodium was approved for marketing in China for the treatment of adult patients with multidrug-resistant HIV infection.

Lenapavir sodium has a unique mechanism of action. By directly bindingto the interface between HIV-1 viral capsid protein (p24) subunits, it interferes with key steps of viral replication, including viral nuclear uptake, viral assembly and release, thereby inhibiting the virus life cycle. Unlike traditional antiretroviral drugs, lenapavir sodium has a longer half-life and can be injected every six months, significantly improving patient compliance. In clinical trials, lenapavir sodium has shown a protection rate of up to 100% in preventing HIV infection, especially in high-risk groups.

On June 18, 2025, lenapavir sodium was approved by the FDA as an HIV prevention (PrEP) drug in the United States under the trade name Yeztugo. In two large Phase III clinical trials, PURPOSE 1 and PURPOSE 2, Yeztugo showed more than 96% prevention efficacy, meaning it could transform HIV prevention. This approval makes Yeztugo an HIV prevention drug that only needs to be taken twice a year, providing a more convenient prevention option for high-risk populations.

In China, the injection form of lenapavir sodium has been launched in Hainan Boao Lecheng International Medical Tourism Pilot Zone, and patients can obtain it through medical institutions in the region. However, it has not yet been widely marketed nationwide, and the specific medical insurance reimbursement policy and scope of indications still need to be further clarified.

Reference materials:https://www.drugs.com/sunlenca.html