Gilead Sciences has taken a major step towards increasing global access to HIV prevention with the signing of royalty-free voluntary licensing agreements with six generic manufacturers, paving the way for increased production and distribution of lenacapavir, its long-acting HIV prevention medication, in 120 high-incidence and resource-limited countries.The announcement comes swiftly after the drug achieved significant milestones in two pivotal Phase 3 trials PURPOSE 1 and PURPOSE 2.

吉利德科学公司（Gilead Sciences）与六家仿制药制造商签署了免版税的自愿许可协议，为在120个高发病率和资源有限的国家增加其长效艾滋病毒预防药物lenacapavir的生产和分销铺平了道路，从而在全球范围内增加了艾滋病毒预防的机会。在该药物在两个关键的3期临床试验目的1和目的2中取得重大里程碑后，该公告迅速发布。

Data from both studies showcased the superiority of twice-yearly injectable, lenacapavir, compared to once-daily oral Truvada and background HIV incidence rates, prompting Gilead to unblind the trials ahead of schedule, and begin the process of seeking regulatory approval for pre-exposure prophylaxis (PrEP).If approved, the six manufacturers – Dr Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero, and Mylan (a subsidiary of Viatris) – will be able to produce and distribute generic versions of lenacapavir without paying royalties to Gilead.Lenacapavir, a first-in-class capsid inhibitor, is notable for its ability to inhibit HIV at multiple stages of its lifecycle.

这两项研究的数据显示，与每天一次的口服特鲁瓦达和背景艾滋病毒发病率相比，每年两次的注射用lenacapavir具有优越性，这促使吉利德提前揭盲试验，并开始寻求监管部门批准暴露前预防（PrEP）。如果获得批准，六家制造商——Reddy博士实验室有限公司、Emcure、Eva Pharma、Ferozzons实验室有限公司、Hetero和Mylan（Viatris的子公司）——将能够生产和销售lenacapavir的仿制药，而无需向吉利德支付版税。Lenacapavir是一种一流的衣壳抑制剂，以其在生命周期的多个阶段抑制HIV的能力而闻名。

The drug has already been green-lit in multiple countries for the treatment of adults with multi-drug resistant HIV in combination with other antiretrovirals.In a statement, Daniel O’Day, chairman and chief executive officer at Gilead, highlighted the importance of the initiative: “Given the transformative potential of lenacapavir for prevention, our focus is on making it available as quickly and broadly as possible where the need is greatest.

该药物已在多个国家获得批准，用于与其他抗逆转录病毒药物联合治疗耐多药艾滋病毒的成年人。吉利德董事长兼首席执行官丹尼尔·奥戴（DanielO'Day）在一份声明中强调了这一举措的重要性：“鉴于lenacapavir在预防方面的变革潜力，我们的重点是在需求最大的地方尽可能快速和广泛地提供这一举措。

Gilead teams have been working with urgency to bring on high-volume generic manufacturers now, so that we can ensure a rapid transition to these voluntary.

吉利德团队目前正在紧急工作，以引进大量仿制药制造商，以便我们能够确保快速过渡到自愿生产。