FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it has signed non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical manufacturers to make and sell generic lenacapavir, subject to required regulatory approvals, in 120 high-incidence, resource-limited countries, which are primarily low- and lower-middle income countries.

加利福尼亚州福斯特城（商业新闻短讯）--吉利德科学公司（Nasdaq:GILD）今天宣布，它已经与六家制药制造商签署了非排他性、免版税的自愿许可协议，在120个高发病率、资源有限的国家（主要是中低收入国家）生产和销售仿制药lenacapavir，但需要获得监管部门的批准。

The agreements were signed in advance of any global regulatory submissions to enable these countries to quickly introduce generic versions of lenacapavir for HIV prevention, if approved..

这些协议是在全球监管提交之前签署的，以使这些国家能够在获得批准的情况下迅速推出用于预防艾滋病毒的通用版本的lenacapavir。。

The agreements advance Gilead’s strategy to enable broad, sustainable access to lenacapavir for pre-exposure prophylaxis (PrEP) globally if it is approved, and align with Gilead’s vision of ending the HIV epidemic for everyone, everywhere. Gilead will support low-cost access to the drug in high-incidence, resource-limited countries through a two-part strategy: establishing a robust voluntary licensing program, and planning to provide Gilead-supplied product at no profit to Gilead until generic manufacturers are able to fully support demand.

这些协议推进了吉利德的战略，即如果获得批准，可以在全球范围内广泛、可持续地获得利那帕韦用于暴露前预防（PrEP），并符合吉利德在世界各地结束艾滋病毒流行的愿景。。

Additionally, the agreements cover not only lenacapavir for HIV prevention (pending approval), but also lenacapavir for HIV treatment in heavily treatment-experienced (HTE) adults with multi-drug resistant HIV..

此外，这些协议不仅涵盖了lenacapavir用于艾滋病毒预防（待批准），还涵盖了lenacapavir用于治疗经验丰富（HTE）的多重耐药艾滋病毒成年人的艾滋病毒治疗。。

“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,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead. “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 license partners after lenacapavir for PrEP is approved.”.

吉利德董事长兼首席执行官丹尼尔·奥戴（DanielO'Day）表示：“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它。”。“吉利德团队目前正在紧急工作，以引进大量仿制药制造商，以便我们能够确保在lenacapavir for PrEP获得批准后，快速过渡到这些自愿许可合作伙伴。”。

The generic companies that will manufacture and supply lenacapavir to the 120 countries are Dr. Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero and Mylan, a subsidiary of Viatris.

将向120个国家生产和供应lenacapavir的仿制药公司有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。

Gilead selected its partners based on rigorous criteria, given the challenges of manufacturing a complex medicine like lenacapavir. All six partners have successfully collaborated with Gilead to produce high-quality generic versions of medicines for HIV or other infectious diseases and are well equipped to produce sterile injectable medicines.

考虑到生产像lenacapavir这样复杂药物的挑战，吉利德根据严格的标准选择了合作伙伴。所有六个合作伙伴都与吉利德成功合作，生产高质量的艾滋病毒或其他传染病仿制药，并拥有生产无菌注射药物的良好设备。

In selecting the licensees, Gilead listened to global health advocates and organizations that advised partnering with manufacturers from multiple countries and continents..

在选择被许可方时，吉利德听取了全球健康倡导者和组织的建议，建议与来自多个国家和大陆的制造商合作。。

Gilead Prioritizing Registration in 18 Countries with High Incidence to Provide Lenacapavir Until Generic Versions are Available

吉利德优先在18个发病率高的国家注册，以提供Lenacapavir，直到通用版本可用

The licensees announced today will build manufacturing capacity for lenacapavir as quickly as possible, but this process will take time. To provide Gilead-supplied lenacapavir until generic versions are available, Gilead is prioritizing registration in 18 countries that represent about 70% of the HIV burden in the countries named in the license.

今天宣布的被许可方将尽快为lenacapavir建立生产能力，但这一过程需要时间。。

These countries, identified in consultation with external partners, are Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia and Zimbabwe..

与外部合作伙伴协商确定的这些国家是博茨瓦纳、埃斯瓦蒂尼、埃塞俄比亚、肯尼亚、莱索托、马拉维、莫桑比克、纳米比亚、尼日利亚、菲律宾、卢旺达、南非、坦桑尼亚、泰国、乌干达、越南、赞比亚和津巴布韦。。

Gilead to Begin Regulatory Filings for Lenacapavir for PrEP by the End of 2024

吉利德将在2024年底前开始向Lenacapavir提交PrEP监管文件

Earlier this year, two pivotal Phase 3 trials of lenacapavir for PrEP, PURPOSE 1 and PURPOSE 2, were both unblinded early because they met their key efficacy endpoints of superiority of twice-yearly lenacapavir to once-daily oral Truvada® and background HIV incidence. PURPOSE 1 enrolled cisgender women in South Africa and Uganda, and PURPOSE 2 enrolled cisgender men, transgender men, transgender women and non-binary individuals in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States who have sex with partners assigned male at birth.

今年早些时候，lenacapavir用于PrEP的两项关键的3期临床试验，目的1和目的2，都是早期公开的，因为它们达到了关键的疗效终点，即每年两次的lenacapavir优于每日一次的口服Truvada®和背景HIV发病率。目的1在南非和乌干达招募了顺性别女性，目的2在阿根廷、巴西、墨西哥、秘鲁、南非、泰国和美国招募了顺性别男性、跨性别男性、跨性别女性和非二元个体，他们在出生时与指定的男性伴侣发生性关系。

Gilead is committed to ensuring that individuals who participated in the PURPOSE studies have access to lenacapavir for PrEP post-trial..

Gilead致力于确保参与目的研究的个人能够获得lenacapavir进行PrEP后试验。。

Based on data from these trials, Gilead will begin a series of global regulatory filings by the end of 2024. For high-incidence, resource-limited countries, Gilead is exploring frameworks such as the European Medicines Agency’s EU Medicines for All with the aim of expediting both national regulatory procedures and the attainment of WHO prequalification.

根据这些试验的数据，吉利德将在2024年底前开始一系列全球监管备案。对于高发病率、资源有限的国家，吉利德正在探索诸如欧洲药品管理局（European Medicines Agency）的欧盟全民药物等框架，目的是加快国家监管程序和获得世卫组织资格预审。

Updates on regulatory filings for lenacapavir for PrEP will be shared as discussions with regulatory bodies progress..

随着与监管机构的讨论进展，将分享lenacapavir for PrEP监管文件的最新信息。。

Extensive Consultations with HIV Community

与艾滋病毒社区广泛协商

Gilead’s strategy to enable broad access to lenacapavir for PrEP reflects input from more than 100 global health stakeholders. Through these discussions, four essential priorities have consistently emerged: delivering long-acting PrEP with speed, at sufficient volume to meet demand, at prices that enable widespread availability and in coordination with partners on the ground.

吉利德（Gilead）为PrEP提供广泛使用lenacapavir的策略反映了100多个全球卫生利益相关者的意见。通过这些讨论，始终出现了四个基本的优先事项：快速提供长效PrEP，数量足以满足需求，价格能够广泛提供，并与当地合作伙伴协调。

These priorities are guiding every step of Gilead's strategy..

这些优先事项指导着吉利德战略的每一步。。

The agreements also build upon Gilead’s two decades of innovation and leadership in global access to medicines. Gilead's partnerships with generic drug manufacturers have helped enable millions of people to benefit from high-quality, low-cost therapies for HIV, viral hepatitis and COVID-19. More than 30 million treatments for HIV, HBV, HCV and COVID-19 have been made available in low- and middle-income countries as a result of partnerships with generic licensees, governments and NGOs..

这些协议还建立在吉利德二十年来在全球药品获取方面的创新和领导地位之上。吉利德与仿制药制造商的合作关系帮助数百万人受益于高质量、低成本的艾滋病毒、病毒性肝炎和新型冠状病毒肺炎治疗。由于与仿制药许可证持有人、政府和非政府组织的合作，中低收入国家已经提供了3000多万种艾滋病毒、乙型肝炎病毒、丙型肝炎病毒和新型冠状病毒治疗。。

The use of lenacapavir for the prevention of HIV is investigational, is not approved anywhere globally, and the safety and efficacy for this use have not been established.

lenacapavir用于预防艾滋病毒的用途正在研究中，尚未在全球任何地方获得批准，这种用途的安全性和有效性尚未确定。

There is currently no cure for HIV or AIDS.

目前还没有治愈艾滋病毒或艾滋病的方法。

About the PURPOSE Program

Gilead’s landmark PURPOSE program is the most comprehensive and diverse HIV prevention trial program ever conducted. The program comprises five HIV prevention trials around the world that are focused on innovation in science, trial design, community engagement and health equity.

吉列德具有里程碑意义的目标计划是有史以来进行的最全面和多样化的艾滋病毒预防试验计划。该计划包括世界各地的五项艾滋病毒预防试验，重点是科学创新、试验设计、社区参与和健康公平。

The PURPOSE trials are evaluating the safety and efficacy of an investigational, twice-yearly injectable medicine, lenacapavir, to reduce the chance of getting HIV. The Phase 2 and 3 program, consisting of PURPOSE 1-5, is assessing the potential of lenacapavir to help a diverse range of people around the world who could benefit from PrEP..

目的试验是评估一种每年两次的研究性注射药物lenacapavir的安全性和有效性，以减少感染艾滋病毒的机会。第二阶段和第三阶段计划由目标1-5组成，正在评估lenacapavir的潜力，以帮助世界各地可以从PrEP中受益的各种各样的人。。

More information about the PURPOSE program, including individual trial descriptions, populations and locations, can be found at www.purposestudies.com.

有关目的计划的更多信息，包括个人试验描述，人群和地点，请访问www.purposetudies.com。

About Lenacapavir

可怕的鬼魂关于Lenacapavir

Lenacapavir is approved in multiple countries for the treatment of adults with multi-drug resistant HIV in combination with other antiretrovirals. The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established.

Lenacapavir在多个国家被批准与其他抗逆转录病毒药物联合用于治疗患有多重耐药艾滋病毒的成年人。lenacapavir用于艾滋病毒预防的研究正在进行中，lenacapavir的安全性和有效性尚未确定。

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 in vitro to other existing drug classes..

lenacapavir的多阶段作用机制与其他目前批准的抗病毒药物不同。虽然大多数抗病毒药物仅作用于病毒复制的一个阶段，但lenacapavir旨在在其生命周期的多个阶段抑制HIV，并且在体外对其他现有药物类别没有已知的交叉耐药性。。

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..

在吉利德艾滋病毒预防和治疗研究项目的多项正在进行和计划中的早期和晚期临床研究中，Lenacapavir被评估为一种长效选择。Lenacapavir正在被开发为未来潜在的艾滋病毒治疗的基础，其目标是提供长效口服和注射选择，具有多种给药频率，联合或作为单一药物，有助于解决受艾滋病毒影响的人和社区的个人需求和偏好。。

About Gilead HIV

关于Gilead 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 12 HIV medications, 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.

35多年来，吉利德一直是艾滋病毒领域的领先创新者，推动了治疗、预防和治疗研究的进步。吉利德研究人员开发了12种艾滋病毒药物，包括第一种治疗艾滋病毒的单片剂方案，第一种用于暴露前预防的抗逆转录病毒药物（PrEP），以帮助减少新的艾滋病毒感染，以及第一种每年两次服用的长效注射艾滋病毒治疗药物。

Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people..

我们在医学研究方面的进步有助于将艾滋病毒转化为数百万人可治疗、可预防的慢性病。。

Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships , collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere.

吉利德致力于继续进行科学创新，为世界各地艾滋病毒感染者不断变化的需求提供解决方案。通过伙伴关系、合作和慈善捐赠，该公司还旨在改善教育，扩大获得护理的机会并解决护理障碍，目标是在任何地方结束艾滋病毒在每个人身上的流行。

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

在关注艾滋病的资助者发布的一份报告中，吉利德被公认为艾滋病相关项目的主要慈善资助者之一。。

Forward-Looking Statements

前瞻性声明

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving lenacapavir (such as the PURPOSE 1 trials); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; Gilead’s ability to effectively manage the supply and distribution of lenacapavir, including through direct supply as well as indirect supply through the voluntary licensing agreements, and the ability of the parties to meet potential demand for lenacapavir, in each case, subject to necessary regulatory approvals; and any assumptions underlying any of the foregoing.

本新闻稿包括1995年《私人证券诉讼改革法案》所指的前瞻性声明，这些声明受到风险、不确定性和其他因素的影响，包括吉利德在预期时间表内或根本没有启动、进展和完成临床试验的能力，以及正在进行的和额外的临床试验（包括涉及lenacapavir的试验（如目的1试验））产生不利结果的可能性；与监管申请和相关备案和批准时间表相关的不确定性，包括lenacapavir for PrEP的监管申请，以及任何监管批准（如果获得批准）可能会受到使用上的重大限制或相关监管机构撤回或其他不利行动的风险；吉利德可能会做出战略决定，停止开发目前正在评估的适应症的lenacapavir，因此，lenacapavir可能永远无法成功商业化用于此类适应症；吉利德有效管理来那帕韦的供应和分销的能力，包括通过自愿许可协议的直接供应和间接供应，以及各方满足来那帕韦潜在需求的能力，在每种情况下都需要获得必要的监管批准；以及基于上述任何一项的任何假设。

These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements.

这些以及其他风险、不确定性和因素在吉利德提交给美国证券交易委员会的截至2024年6月30日的季度10-Q表季度报告中有详细描述。这些风险、不确定性和其他因素可能导致实际结果与前瞻性声明中提及的结果存在重大差异。

All statements othe.

所有声明都是。

U.S. full Prescribing Information for Truvada, including Boxed Warning, and lenacapavir are available at www.gilead.com.

U、 有关特鲁瓦达的完整处方信息，包括盒装警告和lenacapavir，请访问www.gilead.com。

Gilead and the Gilead logo, Truvada, and Truvada for PrEP are registered trademarks of Gilead Sciences, Inc., or its related companies.

Gilead和Gilead徽标、Truvada和Truvada for PrEP是Gilead Sciences，Inc.或其关联公司的注册商标。

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).

有关吉利德的更多信息，请访问公司网站www.Gilead.com，在X/Twitter（@Gilead Sciences）和LinkedIn（@Gilead Sciences）上关注吉利德。