Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) has granted marketing authorization for Yeytuo

吉利德科学公司（纳斯达克股票代码：GILD）今天宣布，欧盟委员会 (EC) 已授予 Yeytuo 上市许可。

(lenacapavir)—the company’s twice-yearly injectable HIV-1 capsid inhibitor—for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk who weigh at least 35kg. Yeytuo

(lenacapavir)—该公司每年两次注射的HIV-1衣壳抑制剂—用于暴露前预防（PrEP），以降低体重至少35公斤且具有较高HIV-1感染风险的成年人和青少年通过性行为感染HIV-1的风险。

is the first and only twice-yearly PrEP option to be approved for use in the European Union’s 27 member states, as well as Norway, Iceland and Liechtenstein.

是首个也是唯一一个获准在欧盟27个成员国以及挪威、冰岛和列支敦士登使用的半年一次的PrEP选项。

The marketing authorization application (MAA) was reviewed under an accelerated timeline based on the assessment by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) that twice-yearly Yeytuo

基于欧洲药品管理局（EMA）人用医药产品委员会（CHMP）的评估，Yeytuo每半年一次的上市许可申请（MAA）按照加快的时间表进行了审查。

is a product of major interest for public health. In July,

是公共卫生重点关注的产品。七月，

the CHMP adopted a positive opinion

CHMP采纳了积极的意见

recommending Yeytuo for EC authorization. Additionally, lenacapavir will be granted one additional year of market protection in the EU as a result of the new indication, following a scientific evaluation prior to authorization that it brought significant clinical benefit in comparison to existing therapies..

推荐Yeytuo获得EC授权。此外，由于新适应症的增加，lenacapavir将在欧盟获得额外一年的市场保护。在授权前的科学评估中表明，与现有疗法相比，它带来了显著的临床效益。

“Yeytuo’s rapid authorization by the European Commission underscores the rigor of our clinical data and the transformative potential of Yeytuo to help address the urgent unmet need in HIV prevention across Europe,” said Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead Sciences. “This milestone is a testament to the 17 years of Gilead research that delivered this breakthrough PrEP medication, underpinned by decades of leadership in HIV innovation.”.

“欧盟委员会对Yeytuo的快速授权证明了我们的临床数据的严谨性，以及Yeytuo在帮助应对欧洲HIV预防方面紧迫的未满足需求方面的变革潜力，”Gilead Sciences首席医学官Dietmar Berger博士说道。“这一里程碑证明了Gilead公司17年的研究成果，带来了这款突破性的PrEP药物，并依托于其在HIV创新领域数十年的领导地位。”

The EC authorization follows

欧盟委员会的授权遵循

approval by the U.S. Food and Drug Administration (FDA) in June

美国食品药品监督管理局 (FDA) 六月批准

, as well as the

，以及

issuance of guidelines by the World Health Organization (WHO) in July

世界卫生组织 (WHO) 于七月发布指南

that recommended twice-yearly lenacapavir as an additional PrEP option for HIV prevention.

建议将每半年一次的雷纳卡帕韦作为额外的PrEP选项用于HIV预防。

“With around 25,000 new HIV diagnoses in the EU and European Economic Area every year, it’s clear that current prevention options are not working for everyone who needs or wants them, especially among vulnerable populations,” said Jean-Michel Molina, MD, Université Paris Cité, Professor of Infectious Diseases and Head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals.

“每年在欧盟和欧洲经济区约有25,000例新的HIV诊断，很明显，当前的预防措施并没有为所有需要或想要它们的人奏效，尤其是在脆弱人群中，”巴黎西岱大学传染病教授、圣路易斯和拉里博瓦西埃医院传染病科主任让-米歇尔·莫利纳医学博士表示。

“Yeytuo’s novel twice-yearly dosing schedule and high efficacy could be the transformative HIV prevention option in Europe we’ve been waiting for to help us reduce new infections and make real progress toward ending the HIV epidemic.”.

“Yeytuo的小说式每年两次的给药计划和高效性可能是我们在欧洲等待已久的革命性的HIV预防选择，有助于我们减少新感染人数，并在终结HIV流行方面取得实质性进展。”

EC authorization of Yeytuo

欧盟授权叶拓

is supported by efficacy and safety data from two Phase 3 trials

得到了两项三期试验的有效性和安全性数据的支持

The EC authorization of Yeytuo

欧盟对叶拓的授权

was supported by data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials conducted by Gilead. In the

得到了吉利德公司进行的3期临床试验PURPOSE 1和PURPOSE 2的数据支持。在

PURPOSE 1 trial

目的1试验

NCT04994509

NCT04994509

), data at the primary analysis showed that administration of twice-yearly subcutaneous lenacapavir led to zero HIV infections among 2,134 participants, 100% reduction in HIV infections and superiority of prevention of HIV infections when compared with once-daily oral Truvada

主要分析数据显示，在2134名参与者中，每年两次皮下注射Lenacapavir导致零例HIV感染，与每日一次口服Truvada相比，HIV感染减少了100%，并且在预防HIV感染方面表现出优越性。

(emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF)

（恩曲他滨200毫克和替诺福韦二吡呋酯富马酸盐300毫克；F/TDF）

in cisgender women in sub-Saharan Africa. In the

在撒哈拉以南非洲的顺性别女性中。在

PURPOSE 2 trial

目的2试验

NCT04925752

NCT04925752

), at the primary analysis there were two HIV infections among 2,179 participants in the twice-yearly subcutaneous lenacapavir group, demonstrating 99.9% of participants did not acquire HIV infection and superiority of prevention of HIV infections when compared with once-daily oral Truvada among a broad and geographically diverse range of cisgender men and gender-diverse people.

），在初步分析中，每年两次接受皮下注射Lenacapavir的2179名参与者中有两人感染了艾滋病毒，这表明99.9%的参与者没有感染艾滋病毒，在广泛的、地理上多样化的顺性别男性和性别多样化人群中，与每日一次口服Truvada相比，预防艾滋病毒感染的效果更优。

In both trials, lenacapavir demonstrated superiority of prevention of HIV infections when compared with background HIV incidence (bHIV).

在两项试验中，与背景 HIV 发生率 (bHIV) 相比，lenacapavir 均显示出对 HIV 感染预防的优越性。

and was generally well-tolerated, with no significant or new safety concerns identified

并且通常耐受性良好，没有发现显著的或新的安全性问题。

Data from both trials were published in

两项试验的数据均发表在

The New England Journal of Medicine

新英格兰医学杂志

and based in part on the trial results, in December 2024 the journal

并且部分基于试验结果，2024年12月期刊

Science

科学

named lenacapavir its 2024 “Breakthrough of the Year.”

命名为lenacapavir的药物被评为2024年“年度突破”。

Continued global regulatory filings and milestone partnerships for lenacapavir for PrEP

继续为Lenacapavir进行全球监管申报和达成预防性用药（PrEP）的里程碑合作伙伴关系

Gilead is executing a global access strategy informed by health advocates and organizations that prioritizes speed and enables the most efficient paths for regulatory review, approval of and access to twice-yearly lenacapavir for PrEP. Beyond approvals in the U.S. and EU, Gilead has also filed for regulatory review of twice-yearly lenacapavir for PrEP with authorities in Australia, .

吉利德正在执行一项由健康倡导者和组织告知的全球准入策略，该策略优先考虑速度，并为每年两次的lenacapavir用于PrEP的监管审查、批准和获取提供最有效的途径。除了在美国和欧盟获得批准外，吉利德还向澳大利亚的监管机构提交了每年两次的lenacapavir用于PrEP的审查申请。

Brazil

巴西

, Canada, South Africa and Switzerland. Additionally, now that lenacapavir for PrEP has received approvals in the U.S. and the EU, Gilead is preparing filings in Argentina, Mexico and Peru.

，加拿大、南非和瑞士。此外，现在预防性用药Lenacapavir已在美国和欧盟获得批准，吉利德正准备在阿根廷、墨西哥和秘鲁提交申请。

Following the

紧跟

recent EU-Medicines for all (EU-M4all) positive opinion for lenacapavir for PrEP

近期欧盟全民药品（EU-M4all）对Lenacapavir用于PrEP的积极意见

, Gilead intends to pursue submissions to national regulatory authorities in low- and middle-income countries (LMIC) utilizing the opinion to facilitate accelerated review timelines. This includes priority registrations covering 18 countries that represent 70% of the HIV burden of the 120 countries named in Gilead’s .

，吉利德打算利用这一意见向低收入和中等收入国家（LMIC）的国家监管机构提交申请，以促进加速审查时间表。这包括覆盖18个国家的优先注册，这些国家占吉利德公司所提及的120个国家中70%的艾滋病毒负担。

previously announced

之前已宣布

voluntary licensing agreements. The EU-M4all procedure also enables a streamlined assessment for World Health Organization (WHO) prequalification. Additionally, in July,

自愿许可协议。欧盟M4all程序还能够简化世界卫生组织（WHO）预认证的评估流程。此外，在七月，

Gilead announced a strategic partnership agreement

吉利德宣布了一项战略合作协议

with The Global Fund to Fight AIDS, Tuberculosis and Malaria to supply lenacapavir for PrEP for up to two million people in primarily low- and lower-middle-income countries, if approved.

与全球抗击艾滋病、结核病和疟疾基金合作，一旦获得批准，将向主要低收入和中低收入国家提供多达两百万人的PrEP药物lenacapavir。

For more information about Gilead’s access strategy for LMICs,

有关吉利德针对低收入和中等收入国家的准入策略的更多信息，

see Gilead’s LMIC access page

查看吉利德的中低收入国家获取页面

.

。

Lenacapavir for PrEP is not approved by any regulatory authority outside of the U.S. and the EU.

用于PrEP的Lenacapavir尚未获得美国和欧盟以外任何监管机构的批准。

There is currently no cure for HIV or AIDS.

目前尚无治愈艾滋病或艾滋病毒的方法。

About Lenacapavir

关于Lenacapavir

Lenacapavir is approved in multiple countries as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents who are at risk of HIV acquisition. Lenacapavir is also approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals..

Lenacapavir已在多国获批作为暴露前预防（PrEP）用药，用于降低有感染风险的成人和青少年通过性行为感染HIV的风险。Lenacapavir还获批在多国与其它抗逆转录病毒药物联合使用，用于治疗成人多药耐药的HIV感染。

The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited .

lenacapavir 的多阶段作用机制不同于其他目前获批的抗病毒药物类别。大多数抗病毒药物仅作用于病毒复制的一个阶段，而 lenacapavir 旨在抑制 HIV 生命周期的多个阶段，并且未表现出已知的交叉耐药性。

in vitro

体外

to other existing drug classes.

与其他现有的药物类别相比。

Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV.

Lenacapavir 正在吉利德的 HIV 预防和治疗研究项目中，作为长效选项进行多项正在进行及计划中的早期和晚期临床研究评估。Lenacapavir 正在被开发为未来潜在 HIV 疗法的基础，目标是提供长效口服和注射选项，具有多种给药频率，可联合使用或作为单一药物，以帮助满足受 HIV 影响的个人和社区的需求与偏好。

The journal .

期刊。

Science

科学

named lenacapavir its 2024 “Breakthrough of the Year.”

命名为lenacapavir的药物被评为2024年“年度突破”。

EU Indication for Yeytuo

欧盟对叶托的指示

Yeytuo injection is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents with increased HIV-1 acquisition risk weighing at least 35kg.

Yeytuo注射与安全性行为实践相结合，用于暴露前预防（PrEP），以降低体重至少35公斤且HIV-1感染风险增高的成人和青少年的性传播HIV-1感染风险。

U.S. Indication for Yeztugo

美国Yeztugo适应症

Yeztugo (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35kg) who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo.

Yeztugo (lenacapavir) 注射液，463.5 mg/1.5 mL，适用于暴露前预防（PrEP），以降低有性传播HIV-1风险的成人和青少年（≥35公斤）感染HIV-1的风险。在开始使用Yeztugo之前，个体必须进行HIV-1检测并结果为阴性。

About Gilead HIV

关于吉利德HIV

For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV

三十多年来，吉利德一直是HIV领域的领先创新者，推动治疗、预防和治愈研究的进步。吉利德的研究人员已经开发了13种HIV相关产品。

medications

药物

, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in

，包括首个用于治疗HIV的单片剂方案、首个用于暴露前预防（PrEP）的抗逆转录病毒药物以帮助减少新的HIV感染，以及首个每年两次注射的长效HIV治疗药物。我们在

medical research

医学研究

have helped to transform HIV into a treatable, preventable, chronic condition for millions of people.

已经帮助将 HIV 转变为一种可治疗、可预防的慢性病，惠及数百万人。

Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through

吉利德致力于持续的科学创新，以满足全球受艾滋病影响人群不断变化的需求。通过

partnerships

伙伴关系

, collaborations and charitable giving, the company also aims to improve education, expand

通过合作和慈善捐赠，公司还旨在改善教育，扩大覆盖面。

access

访问

and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was

并解决护理障碍，目标是为所有人、在所有地方终结艾滋病流行。吉利德

recognized

识别出的

as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS.

作为艾滋病相关项目的主要慈善资助者之一，在艾滋病关注基金会发布的报告中。

About Gilead Sciences

关于吉利德科学公司

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation.

吉利德科学公司是一家生物制药公司，三十多年来一直致力于医学领域的突破，旨在为全人类创造一个更加健康的世界。公司专注于推进创新药物的研发，以预防和治疗危及生命的疾病，包括艾滋病、病毒性肝炎、新冠肺炎、癌症以及炎症等。

Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California..

吉利德在全球35多个国家开展业务，总部位于加利福尼亚州的福斯特城。