首个来那卡帕韦仿制药获FDA暂时批准：每年40美元供120国用于HIV预防，不在美国销售
Dr. Reddy's Laboratories与克林顿健康倡议组织（CHAI）等合作方11月2日宣布，美国食品药品监督管理局（FDA）已暂时批准该公司生产的可注射来那卡帕韦仿制药，这是这款每年注射两次的HIV预防药的首个仿制版本。此次批准通过FDA的总统艾滋病紧急救援计划（PEPFAR）通道作出。
这款仿制药将按每人每年40美元的价格，供应吉利德科学自愿许可计划覆盖的120个中低收入国家，用于HIV暴露前预防（PrEP）。合作方说，首批供应预计在2026年底前到达有关国家，2027年起更广泛供应。
「暂时批准」是FDA对尚在专利期内的仿制药的标准处理：药品本身已达到FDA标准，但在原研药专利与独占权失效前不能在美国销售。吉利德的品牌药Yeztugo于2025年6月获批用于HIV预防，目前仍受专利保护，是唯一在美国销售的来那卡帕韦预防产品。
来那卡帕韦由吉利德开发，大型临床试验显示其预防HIV的效果超过99.9%。Dr. Reddy's把该药的预防与治疗两项适应症合并在同一份申请中，经FDA的505(b)(2)通道申报并获得优先审评，目标审评期为六个月；此次批准距品牌药获批约16个月。
参与推动这款仿制药开发的机构还包括全球卫生机构Unitaid与南非的Wits生殖健康与HIV研究所。
（来源：Dr. Reddy's Laboratories与克林顿健康倡议组织公告）
First Generic Lenacapavir Wins Tentative FDA Approval: $40 a Year for HIV Prevention Across 120 Countries, Not for Sale in the U.S.
Dr. Reddy's Laboratories, together with the Clinton Health Access Initiative (CHAI) and other partners, announced on November 2 that the U.S. Food and Drug Administration has granted tentative approval to the company's injectable lenacapavir, the first generic version of the twice-yearly HIV prevention shot. The approval was granted under the FDA's President's Emergency Plan for AIDS Relief (PEPFAR) program.
The generic will be supplied at $40 per person per year across the 120 low- and middle-income countries covered by Gilead Sciences' voluntary licensing program, for HIV pre-exposure prophylaxis (PrEP). The partners said first supplies are expected to reach countries by the end of 2026, with broader availability in 2027.
Tentative approval is the FDA's standard designation for a generic that meets its standards while the originator product is still under patent: it cannot be sold in the United States until the patents and exclusivity expire. Gilead's brand-name version, Yeztugo, was approved for HIV prevention in June 2025, remains patent-protected, and is the only lenacapavir prevention product sold in the U.S.
Lenacapavir was developed by Gilead and showed more than 99.9 percent effectiveness in large clinical trials. Dr. Reddy's combined the drug's prevention and treatment indications in a single application filed through the FDA's 505(b)(2) pathway and received priority review, which targets a decision within six months; the tentative approval came about 16 months after the brand product was approved.
Unitaid and South Africa's Wits Reproductive Health and HIV Institute also supported the generic's development.
(Source: Dr. Reddy's Laboratories and Clinton Health Access Initiative announcement)
发布：GSM·美国（发布链接）
图片来源：白宫南草坪悬挂的艾滋病红丝带（资料图，2021年世界艾滋病日）。白宫官方照片，公共领域，经 Wikimedia Commons。 / The AIDS red ribbon displayed on the White House North Portico for World AIDS Day 2021 (file photo). Official White House photo, public domain, via Wikimedia Commons.
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