吉利德(GILD.US)重磅长效HIV疗法“来那帕韦”在华获批上市
智通财经APP获悉，1月2日，NMPA官网显示，吉利德(GILD.US)的HIV疗法来那帕韦钠片及来那帕韦钠注射液（Lenacapavir）的上市申请已获批准。那帕韦钠是一款first-in-class长效HIV衣壳抑制剂，可通过干扰病毒生命周期的多个重要步骤抑制HIV-1的复制，包括抑制由病毒衣壳介导的HIV-1前病毒DNA的摄取、组装和释放，以及病毒衣壳核心的形成，而且对其他现有药物类型没有已知的交叉耐药性。
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。
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