印度药企Dr Reddy's Laboratories Ltd（以下简称“Dr Reddy's”）于周一（11月2日）宣布，美国食品药品监督管理局（USFDA）已授予其每半年注射一次的来那帕韦（lenacapavir）暂定批准，用于HIV（人类免疫缺陷病毒）暴露前预防（PrEP），这为该药物在除美国以外的120个国家获取铺平了道路，依据的是现有的自愿许可协议。
Dr Reddy’s is preparing to roll out its twice-yearly injectable HIV prevention treatment across over a hundred developing nations under a major licensing agreement. Initial supplies are targeted for deployment ahead of 2027. Find out how the company plans to scale manufacturing to meet global demand.
此次批准涵盖来那帕韦用于暴露前预防（PrEP），以降低体重至少77磅（35公斤）的成人和青少年通过性行为感染HIV-1的风险。批准是在USFDA的“总统艾滋病紧急救援计划”（PEPFAR）框架下授予的。
Drug major Dr Reddy’s Laboratories Ltd on Monday (November 2) said the US Food and Drug Administration (USFDA) has granted tentative approval to its twice-yearly injectable lenacapavir for HIV prevention, paving the way for access across 120 countries outside the US under an existing voluntary licensing agreement.
根据现有协议，这种注射剂将以每人每年40美元的价格，在吉利德科学公司（Gilead Sciences）自愿许可覆盖的120个国家供应。吉利德于2024年10月将许可授予Dr Reddy's。
The approval covers the use of lenacapavir for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 77 pounds (35 kg). It was granted under the USFDA’s President’s Emergency Plan for AIDS Relief (PEPFAR) programme.
Dr Reddy's第二季度财报：奈拉替尼销售下滑拖累营收，净利润下降但超预期 2025年9月，Dr Reddy's与国际药物购买机构（Unitaid）、威特沃特斯兰德生殖健康与艾滋病研究所（Wits RHI）以及克林顿卫生获取倡议组织（CHAI）达成协议，以支持产品开发、加速监管审批进程并促进该注射疗法的获取。
Under the existing agreement, the injectable drug will be available at $40 per person per year across 120 countries covered by Gilead Sciences' voluntary licence. Gilead granted the licence to Dr Reddy’s in October 2024.
上述机构支持了每半年注射一次疗法的加速开发和监管审批进程。首批供应预计将在2026年底前抵达相关国家，符合条件的国家将于2027年实现更广泛的供应。
Dr Reddy’s Q2 Results: Net profit falls as lower Lenalidomide sales hit revenue; beats estimates In September 2025, Dr Reddy’s entered into an agreement with Unitaid, the Wits Reproductive Health and HIV Institute (Wits RHI) and the Clinton Health Access Initiative (CHAI) to support product development, accelerate the regulatory pathway and enable access to the injectable treatment.
Dr Reddy’s Laboratories Ltd API 和服务部首席执行官 Deepak Sapra 表示：“这对我们 Dr Reddy’s 的所有人来说，是一个巨大的自豪时刻。以可负担的价格开发和生产像 lenacapavir 这样复杂的长效注射剂，需要强大的科学能力和制造专长，以应对紧迫的可及性需求。
The organisations supported the accelerated development and regulatory pathway for the twice-yearly injection. The first supplies are expected to reach countries before the end of 2026, with broader availability across eligible countries in 2027.
Dr Reddy's Mexico API facility gets 2 observations in US FDA records assessment 美国 FDA 的批准验证了这项工作，并让我们离在低收入和中等收入国家为人们提供这种每年两次的 HIV 预防选择又近了一大步。我们感谢 Gilead 提供自愿许可，也感谢 Unitaid、Wits RHI 和 CHAI 在加速这一进程方面的支持。”
Unitaid 执行主任 Dr Philppe Duneton 表示：“Unitaid 的早期风险投入正在帮助缩短科学突破与各国实际可及性之间的时间。凭借世界一流的 HIV 治疗，我们在四年内完成了过去需要十年才能完成的工作。
Deepak Sapra, Chief Executive Officer, API and Services, Dr Reddy’s Laboratories Ltd, said, "This is a moment of immense pride for all of us at Dr Reddy’s. Developing and manufacturing a complex long-acting injectable like lenacapavir at an affordable price required strong scientific capabilities and manufacturing expertise to address an urgent access need.
现在，借助 lenacapavir，我们帮助将这一时间缩短到了一年多一点。对于非洲的年轻女性来说，这意味着能更快获得一项开创性的 HIV 预防选择，有可能避免无数感染，并在 HIV 应对中推动有意义的变革。” CHAI 首席执行官 Dr Neil Buddy Shah 表示：“对于面临 HIV 风险的人来说，每天服用一片药来预防一种他们并未感染的疾病，是一件很难做到的事。每年两次注射一种几乎 100% 有效预防 HIV 的产品，彻底改变了这一切。”
Dr Reddy's Mexico API facility gets 2 observations in US FDA records assessment The US 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. We are grateful to Gilead for the voluntary licence and to Unitaid, Wits RHI and CHAI for their support in accelerating this journey." Dr Philppe Duneton, Executive Director at Unitaid, said, "Unitaid’s early risk-taking is helping shorten the time between a scientific breakthrough and real access in countries. With best-in-class HIV treatment, we delivered in four years what used to take ten.
Dr Reddy's Laboratories股价因司美格鲁肽批次担忧、供应延迟下跌6%“非洲已有超过12.5万人开始使用来那度韦，今天的批准让我们更接近以每年仅40美元的价格让数百万人用上这种药物。在原研药获批仅16个月后就获批仿制药，而不是十年后，这表明当我们从一开始就优先考虑可及性时，能够实现什么。这应成为全球卫生的新标准。”
Now, with lenacapavir, we have helped shorten that timeline to just over a year. For young women in Africa, this translates into faster access to a groundbreaking HIV prevention option, with the potential to avert countless infections and drive meaningful change in the HIV response." Dr Neil Buddy Shah, CEO of CHAI, said, "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.
Dr Reddy's Laboratories Ltd股价在BSE（孟买证券交易所）收于1340.25印度卢比，下跌9.95印度卢比，跌幅0.74%。
Dr Reddy's Laboratories shares fall 6% on semaglutide batch concerns, supply delay More than 125,000 people in Africa have already started on lenacapavir, and today’s approval brings us closer to making it available to millions more for just $40 a year. Getting a generic approved just 16 months after the originator, rather than a decade later, shows what’s possible when we prioritise access from the start. This should be the new standard for global health." Shares of Dr Reddy's Laboratories Ltd ended at ₹1,340.25, down by ₹9.95, or 0.74%, on the BSE.