FDA暂时批准首款HIV预防长效注射仿制药：每人每年40美元、覆盖120个国家
美国食品药品监管局（FDA）已暂时批准首款用于预防 HIV 的长效注射仿制药来那卡帕韦（lenacapavir），距原研药2025年6月获批仅16个月。开发方 Dr. Reddy's Laboratories 与支持机构11月2日在日内瓦宣布了这一消息，称这是重大 HIV 创新药物最快的获批时间线之一。
来那卡帕韦每年只需注射两次，预防效果接近100%。在既有合作协议下，Dr. Reddy's 的仿制注射剂将以每人每年40美元的价格，供应 Gilead 自愿许可覆盖的120个中低收入国家；首批供货预计2026年底前抵达，2027年更广泛铺开。
这项批准源于2025年9月 Unitaid、Wits RHI、克林顿健康倡议组织（CHAI）与 Dr. Reddy's 达成的里程碑式定价协议，有关机构为仿制药的开发与申报提供了资金、技术与监管支持。早在仿制药上市之前，非洲10个早期采用国家已有逾125,000人开始使用 Gilead 的原研来那卡帕韦。
CHAI 首席执行官 Neil Buddy Shah 表示：「对有 HIV 感染风险的人来说，每天吃一片药来预防一种自己还没有的病，是很难坚持的要求。一年两次注射、预防效果接近100%的产品，彻底改变了这一点。」Unitaid 执行主任 Philippe Duneton 表示，该机构早期的风险投入正帮助缩短科学突破与各国实际可及之间的时间。
所谓「暂时批准」（tentative approval）是 FDA 在原研药专利期内对仿制药的标准认定，表示该药已通过安全性、有效性与质量审查，并可由美国政府采购。支持机构表示，下一步是把批准转化为各国的实际引进与社区层面的推广。（来源：克林顿健康倡议组织）
FDA Tentatively Approves First Generic Long-Acting Injectable for HIV Prevention: $40 Per Person Per Year Across 120 Countries
The U.S. Food and Drug Administration (FDA) has granted tentative approval to the first generic long-acting injectable lenacapavir for HIV prevention, just 16 months after the originator product was approved in June 2025. Dr. Reddy's Laboratories, which developed the generic, and its supporting partners announced the decision in Geneva on November 2, calling it one of the fastest timelines to approval for a major HIV innovation to date.
Lenacapavir requires only two injections a year and is almost 100% effective at preventing HIV. Under the existing partnership agreement, Dr. Reddy's lenacapavir injection will be available at $40 per person per year for the 120 low- and middle-income countries included in Gilead's voluntary license. First supplies are expected to reach countries before the end of 2026, with broader availability in 2027.
The approval follows a landmark pricing agreement announced in September 2025 between Unitaid, Wits RHI, the Clinton Health Access Initiative (CHAI), and Dr. Reddy's, which combined an early pricing commitment with financial, technical and regulatory support. Even before generic availability, over 125,000 people in 10 early adopter African countries have already started Gilead's lenacapavir.
"For someone at risk of HIV, taking a pill every day to prevent a disease they don't have is a hard thing to ask. Two injections a year, of a product that is almost 100% effective at preventing HIV, changes that entirely," said Dr. Neil Buddy Shah, CEO of CHAI. Dr. Philippe Duneton, Executive Director of Unitaid, said the organization's early risk-taking is helping shorten the time between a scientific breakthrough and real access in countries.
Tentative approval is the FDA's standard designation for generics while the originator remains under patent; it means the drug has met the agency's safety, efficacy and quality standards and enables procurement by the U.S. government. The partners said the next step is turning approval into country-level introduction and community engagement. (Source: Clinton Health Access Initiative)
来源：克林顿健康倡议组织
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）。Flickr 用户（White House）图，CC BY 2.0，经 Wikimedia Commons。 / The AIDS red ribbon displayed at the White House (file photo). CC BY 2.0, via Wikimedia Commons.
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