吉利德科学行使选择权，授权Assembly Biosciences的螺旋酶-引物酶抑制剂项目用于复发性生殖器疱疹（在新窗口中打开）-动脉网

Gilead Sciences Exercises Option to License Assembly Biosciences’ Helicase-Primase Inhibitor Programs for Recurrent Genital Herpes (opens in new window)

吉利德等信源发布 2025-12-22 09:54



可切换为仅中文







– Weekly Oral Helicase-Primase Inhibitor Programs' Early Data Potentially Supportive of First New Treatment for Recurrent Genital Herpes in 25 Years –

– 每周口服解旋酶-引物酶抑制剂项目的早期数据可能支持25年来复发性生殖器疱疹的首个新疗法 –

FOSTER CITY, Calif. & SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--

加利福尼亚州福斯特城和加利福尼亚州南旧金山——（BUSINESS WIRE）——

Gilead Sciences, Inc. (Nasdaq: GILD) and Assembly Biosciences, Inc. (Nasdaq: ASMB), today announced Gilead has exercised its combined option to exclusively license Assembly Bio’s herpes simplex virus (HSV) helicase-primase inhibitor programs, including long-acting investigational candidates ABI-1179 and ABI-5366 for recurrent genital herpes.

吉利德科学公司（纳斯达克股票代码：GILD）和Assembly Biosciences公司（纳斯达克股票代码：ASMB）今天宣布，吉利德已行使联合选择权，独家授权Assembly Bio的单纯疱疹病毒（HSV）解旋酶-引物酶抑制剂项目，包括用于复发性生殖器疱疹的长效研究候选药物ABI-1179和ABI-5366。

These represent the first programs Gilead will advance under the ongoing Assembly Bio .

这些代表了吉利德将在正在进行的Assembly Bio计划下推进的首批项目。

R&D collaboration

研发合作

, reinforcing the companies’ commitment to building a novel antiviral pipeline and driving long-term growth through innovative therapies addressing significant unmet needs.

，重申了公司致力于构建新的抗病毒产品线，并通过创新疗法满足重大未满足需求来推动长期增长的承诺。

Genital herpes, caused by HSV, is a chronic infection that leads to painful lesions, psychological and social stigma, and an increased risk of HIV acquisition. Over four million people in the U.S. and major European countries experience recurrent genital herpes, with HSV type 2 (HSV-2) infections typically associated with multiple recurrences each year.

由单纯疱疹病毒（HSV）引起的生殖器疱疹是一种慢性感染，会导致疼痛性病灶、心理和社会污名，并增加感染艾滋病毒的风险。在美国和主要欧洲国家，有超过四百万人患有复发性生殖器疱疹，其中单纯疱疹病毒2型（HSV-2）感染通常每年会引发多次复发。

No new therapies have been approved for HSV in the U.S. or Europe for more than 25 years..

在美国或欧洲，已有25年多没有新的HSV疗法获批。

“At Gilead, we develop novel antiviral therapeutics that aim to deliver meaningful solutions that improve the lives of people affected by serious viral infections. Our research partnership with Assembly Bio has been highly fruitful, and we are excited to continue the clinical development of our herpes simplex virus candidates,“ said Jared Baeten, MD, PhD, Senior Vice President, Clinical Development, Virology Therapeutic Area Head, Gilead Sciences.

“在吉利德，我们开发新型抗病毒疗法，旨在提供有意义的解决方案，改善受严重病毒感染影响的人们的生活。我们与Assembly Bio的研究合作取得了丰硕成果，我们很高兴能够继续推进单纯疱疹病毒候选药物的临床开发。”吉利德科学公司高级副总裁、临床开发负责人、病毒学治疗领域主管Jared Baeten医学博士表示。

“Collaborations and partnerships are key in the pursuit of life-changing innovations.”.

“合作与伙伴关系是追求改变生活的创新的关键。”

ABI-1179 and ABI-5366 are novel long-acting inhibitors of viral helicase-primase, an enzyme essential for herpes virus replication with the potential to improve chronic suppressive therapy for recurrent genital herpes. Positive interim Phase 1b data for ABI-5366 and ABI-1179 demonstrated strong antiviral activity and improvements in clinical outcomes, including significant reduction in virus-positive lesions.

ABI-1179 和 ABI-5366 是新型长效病毒解旋酶引物酶抑制剂，这种酶是疱疹病毒复制所必需的，有潜力改进复发性生殖器疱疹的慢性抑制治疗。ABI-5366 和 ABI-1179 的 1b 期中期数据显示出强大的抗病毒活性，并在临床结果上有所改善，包括显著减少病毒阳性病灶。

Both compounds also exhibit pharmacokinetic and safety profiles supportive of once-weekly oral dosing..

这两种化合物还表现出支持每周一次口服给药的药代动力学和安全性特征。

“We are pleased Gilead has opted in to advance the helicase-primase program for recurrent genital herpes,” said Jason Okazaki, Chief Executive Officer and President of Assembly Bio. “This milestone reflects the strength of our collaboration and the potential of our antiviral pipeline. With Gilead’s proven track record in developing and commercializing antiviral medicines, exercising this option is an important step forward as they take control of ABI-5366 and ABI-1179 and advance closer to delivering long-awaited new treatment options to patients suffering from recurrent genital herpes.”.

“我们很高兴吉利德选择推进用于复发性生殖器疱疹的解旋酶-引物酶项目，” Assembly Bio公司首席执行官兼总裁Jason Okazaki表示，“这一里程碑反映了我们合作的力量以及抗病毒管线的潜力。凭借吉利德在开发和商业化抗病毒药物方面经证实的成功记录，行使这一选择权是重要的一步，因为他们将掌控ABI-5366和ABI-1179，并进一步接近为遭受复发性生殖器疱疹困扰的患者提供期待已久的新治疗选择。”

Terms of the Transaction

交易条款

Under the terms of the 2023 collaboration agreement between Gilead and Assembly Bio, Assembly Bio will receive a $35 million payment for Gilead’s exercise of the combined HSV program option, which comprises both ABI-5366 and ABI-1179. The $35 million payment reflects a $45 million option fee, net of $10 million accelerated funding Assembly Bio received under a December 2024 amendment, which was creditable against future payments.

根据吉利德和Assembly Bio在2023年达成的合作协议条款，因吉利德行使了包含ABI-5366和ABI-1179的综合HSV项目选择权，Assembly Bio将获得3500万美元的付款。这3500万美元反映了4500万美元的选择权费用，减去Assembly Bio在2024年12月修正案下已收到的1000万美元加速资助，该款项可抵扣未来的付款。

Gilead will receive an exclusive license to ABI-5366 and ABI-1179 and will have the sole right and responsibility for further clinical development and commercialization of these programs..

吉利德将获得 ABI-5366 和 ABI-1179 的独家许可，并将拥有这些项目的进一步临床开发和商业化的唯一权利和责任。

Assembly Bio remains eligible for up to $330 million in regulatory and commercial milestones, as well as tiered royalties on net sales. Assembly Bio will also have the right to opt in to share 40% of all costs and profits in the United States in lieu of receiving milestones and royalties for that program in the United States after receipt of development plans and budgets from Gilead next year..

Assembly Bio 仍有资格获得高达 3.3 亿美元的监管和商业里程碑付款，以及按净销售额计算的分层特许权使用费。 Assembly Bio 还有权选择加入，在明年收到吉利德的开发计划和预算后，可在美国分享该计划 40% 的全部成本和利润，以替代在美国获得的里程碑和特许权使用费。

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健康的世界。该公司致力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、癌症和炎症。

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

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福斯特城。

About Assembly Biosciences

关于Assembly Biosciences

Assembly Biosciences is a biotechnology company dedicated to the development of innovative small-molecule therapeutics designed to change the path of serious viral diseases and improve the lives of patients worldwide. Led by an accomplished team of leaders in virologic drug development, Assembly Bio is committed to improving outcomes for patients struggling with the serious, chronic impacts of herpesvirus, HBV and HDV infections.

Assembly Biosciences是一家生物技术公司，致力于开发创新的小分子治疗药物，旨在改变严重病毒性疾病的进程，改善全球患者的生活。在病毒药物开发领域经验丰富的领导团队的带领下，Assembly Bio致力于改善正遭受疱疹病毒、乙型肝炎病毒（HBV）和丁型肝炎病毒（HDV）感染带来的严重慢性影响的患者的治疗效果。

For more information, visit assemblybio.com..

欲了解更多信息，请访问 assemblybio.com。

Gilead Forward-Looking Statements

吉利德前瞻性声明

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 realize the anticipated benefits from the collaboration; difficulties or unanticipated expenses in connection with the collaboration and the potential effects on Gilead’s earnings; the ability of Gilead to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional trials, including those involving programs developed pursuant to the collaboration, such as ABI-1179 and ABI-5366; the ability of Gilead to file applications for regulatory approval or receive regulatory approvals in a timely manner or at all for the investigational programs developed pursuant to the partnership, and the risk that any such 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 any of the investigational programs developed pursuant to the collaboration, and therefore these programs may never be successfully commercialized; and any assumptions underlying any of the foregoing.

本新闻稿包含1995年《私人证券诉讼改革法案》意义下的前瞻性陈述，这些陈述受风险、不确定性和其他因素的影响，包括吉利德实现合作预期效益的能力；与合作相关的困难或意外费用以及其对吉利德盈利的潜在影响；吉利德能否在目前预期的时间内或根本无法启动、推进或完成临床试验，以及来自正在进行或额外试验的不利结果的可能性，包括根据合作协议开发的项目（如ABI-1179和ABI-5366）相关的试验；吉利德是否能够及时提交监管审批申请或获得监管批准以推进合作开发的研究项目，以及任何此类批准（如果获得）可能受到使用上的重大限制或被相关监管机构撤销或其他不利措施的风险；吉利德可能做出战略决策停止开发根据合作协议开发的任何研究项目，因此这些项目可能永远不会成功商业化；以及上述任何陈述所依据的任何假设。

These and other risks, uncertainties and other factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, 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.

这些风险、不确定性及其他因素在吉利德公司截至2025年9月30日的季度10-Q表格季度报告中有详细描述，该报告已提交给美国证券交易委员会。这些风险、不确定性及其他因素可能导致实际结果与前瞻性声明中提到的内容存在重大差异。

All statements other than statements of h.

除历史陈述外的所有陈述。

Assembly Bio Forward-Looking Statements

Assembly Bio 前瞻性声明

The information in this press release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to materially differ. These risks and uncertainties include: Assembly Bio’s ability to realize the potential benefits of its collaboration with Gilead, including all financial aspects of the collaboration and equity investments; Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s collaboration with Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio’s product candidates; clinical and nonclinical data may not differentiate Assembly Bio’s product candidates from other companies’ candidates; Assembly Bio’s ability to maintain financial resources and secure additional funding necessary to continue its research activities, clinical studies, and other business operations; potential effects of changes in government regulation, including as a result of the change in U.S.

本新闻稿中的信息包含前瞻性声明，这些声明受到某些可能导致实际结果出现重大差异的风险和不确定性的影响。这些风险和不确定性包括：Assembly Bio能否实现与Gilead合作的潜在利益，包括合作的所有财务方面及股权投资；Assembly Bio能否在预期的时间框架内或根本启动并完成涉及其治疗产品候选者的临床研究，包括Assembly Bio与Gilead合作所设想的研究；来自临床或非临床研究的安全性和有效性数据可能不支持进一步开发Assembly Bio的产品候选者；临床和非临床数据可能无法使Assembly Bio的产品候选者区别于其他公司的候选者；Assembly Bio能否维持财务资源并获得继续其研究活动、临床研究和其他业务运营所需的额外资金；政府监管变化可能产生的影响，包括由于美国政策变化导致的影响。

administration in 2025; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio’s reports filed with the U.S. Securities and Exchange Commission (the SEC).

2025年的管理；非临床研究的结果可能无法代表临床环境中的疾病行为，也可能无法预测临床研究的结果；以及Assembly Bio不时在其向美国证券交易委员会（SEC）提交的报告中指出的其他风险。

You are urged to consider statements that include the words may, will, would, could, should, might, believes, hopes, estimates, projects, potential, expects, plans, anticipates, intends, continues, forecast, designed, goal or the negative of those words or other comparable words to be uncertain and forward-looking..

您被敦促考虑包含以下词语的陈述：可能、将、会、可以、应该、或许、相信、希望、估计、预测、潜力、预期、计划、预计、打算、继续、展望、设计、目标，或这些词的否定形式或其他类似词语，这些陈述具有不确定性且为前瞻性陈述。

Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. The Assembly Bio name and logo are trademarks of Assembly Bio.

吉利德和吉利德的标志是吉利德科学公司或其相关公司的商标。Assembly Bio 的名称和标志是 Assembly Bio 的商标。

For more information about Gilead, please visit the company’s website at

有关吉利德的更多信息，请访问公司网站

www.gilead.com

, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).

，关注吉利德在X/Twitter（@Gilead Sciences）和LinkedIn（@Gilead-Sciences）。

Gilead Contacts:

吉利德联系方式：

Jessica Smith, Media

杰西卡·史密斯，媒体

public_affairs@gilead.com

公共事务@gilead.com