首个艾滋病预防仿制注射药获 FDA 暂时批准：一年两针、年价40美元
印度药企 Dr. Reddy's Laboratories 与全球卫生机构 Unitaid 等合作方11月2日宣布，美国食品药品监管局（FDA）已对该公司生产的注射用 lenacapavir（来那卡帕韦）仿制药给予暂时批准。这是首个获 FDA 暂时批准的长效注射型艾滋病预防仿制药，为把一年两针的预防方案以每年40美元的价格送往120个中低收入国家，扫清了关键的监管一步。
该仿制药适用于体重至少35公斤的成人与青少年，作为暴露前预防（PrEP）用药，降低经性传播感染 HIV-1 的风险，此次审评经 FDA 的总统艾滋病紧急救援计划（PEPFAR）通道进行。其原研药是美国吉利德科学公司（Gilead Sciences）的 Yeztugo，2025年6月获 FDA 批准用于艾滋病预防，在大型试验中预防效果接近100%，在美国的年价约为28,000美元。Dr. Reddy's 是吉利德授权生产仿制药的六家企业中，第一家拿到暂时批准的。
暂时批准意味着该产品已经达到 FDA 在安全、有效与质量上的全部标准，但因原研药的专利与独占期尚未结束，暂时不能在美国境内销售；这一批准主要服务于中低收入国家的采购与上市程序。年价40美元的协议价于2025年9月达成，参与方包括 Unitaid、克林顿健康倡议组织（Clinton Health Access Initiative）与南非 University of the Witwatersrand 下属的 Wits 生殖健康与艾滋病研究所，与口服 PrEP 的年价大致相当。
按各方公布的时间表，首批仿制药预计在2026年底前送达首批国家，2027年扩大到更多合资格国家。Dr. Reddy's 负责原料药与服务业务的首席执行官 Deepak Sapra 在发布中说：「美国 FDA 的批准验证了这项工作，让我们朝着把一年两针的艾滋病预防方案带给中低收入国家的人们，显著迈近了一步。」
（来源：美国食品药品监管局）
First Generic Injectable HIV Prevention Drug Wins FDA Tentative Approval: Twice-Yearly Shots at $40 a Year
Indian drugmaker Dr. Reddy's Laboratories and its global health partners, including Unitaid, announced on November 2 that the U.S. Food and Drug Administration (FDA) has granted tentative approval to the company's generic injectable lenacapavir. It is the first generic long-acting injectable for HIV prevention to clear this step, removing a key regulatory barrier to supplying a twice-yearly prevention shot at $40 per person per year across 120 low- and middle-income countries.
The generic is intended for adults and adolescents weighing at least 35 kilograms, as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1, and was reviewed through the FDA's President's Emergency Plan for AIDS Relief (PEPFAR) program. The originator drug is Yeztugo, made by U.S. company Gilead Sciences, which the FDA approved for HIV prevention in June 2025; it was nearly 100% effective in large trials and costs about $28,000 a year in the United States. Dr. Reddy's is the first of six manufacturers licensed by Gilead to receive tentative approval.
Tentative approval means the product has met all of the FDA's standards for safety, effectiveness and quality, but cannot yet be sold in the United States because the originator's patent and exclusivity protections remain in force; the approval instead supports procurement and market entry in low- and middle-income countries. The $40 annual price was agreed in September 2025 with Unitaid, the Clinton Health Access Initiative and the Wits Reproductive Health and HIV Institute at South Africa's University of the Witwatersrand, putting it roughly in line with the annual cost of daily oral PrEP.
Under the partners' timeline, initial supplies are expected to reach the first countries before the end of 2026, with broader availability across eligible countries in 2027. Deepak Sapra, Dr. Reddy's chief executive for API and services, said in the release: "The U.S. FDA approval validates that work and brings us a significant step closer to making this twice-yearly HIV prevention option available to people across low- and middle-income countries."
(Source: U.S. Food and Drug Administration)
来源：美国食品药品监管局
发布：GSM·美国（发布链接）
图片来源：lenacapavir（来那卡帕韦）分子结构图（Dzinamarira 等作，CC BY 4.0，经 Wikimedia Commons）
GSM Global · 本篇英文版 English edition of this story
