此前该药物已在美国、欧盟等地区获批用于治疗既往接受过多次治疗、多重耐药的HIV-1感染者。那帕韦钠注射液此前已在美国、欧盟、日本等多个国家上市，是首款获批的每年给药2次HIV治疗药物。那帕韦钠片也仅需每周口服一次。值得一提的是，那帕韦钠在暴露前预防HIV方面也展现了优异的疗效，其针对不同人群的PURPOSE 1研究和PURPOSE 2均已达到了关键疗效终点。The NMPA official website shows that Gilead (GILD.US) has received approval for the marketing application of its HIV therapy lenacapavir tablets and lenacapavir injection.
Zhitung Finance APP learned that on January 2nd, the NMPA official website showed that the marketing application for Gilead's (GILD.US) HIV treatment Lenacapavir has been approved. Lenacapavir is a first-in-class long-acting HIV capsid inhibitor that can suppress the replication of HIV-1 by interfering with multiple critical steps in the viral life cycle, including inhibiting 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, and has no known cross-resistance with other existing drug types.
Previously, this drug has been approved in regions such as the USA and the EU for the treatment of HIV-1 infection in patients who have undergone multiple treatments and have multidrug resistance. Lenacapavir injection had previously been launched in multiple countries including the USA, EU, and Japan, and is the first approved HIV treatment drug administered twice a year. Lenacapavir tablets only need to be taken once a week. It is worth mentioning that Lenacapavir has also demonstrated excellent efficacy in pre-exposure prophylaxis for HIV, with its PURPOSE 1 and PURPOSE 2 studies achieving key efficacy endpoints across different populations.
