Lynkuet™（elinzanetant）在欧盟获批用于治疗与更年期或乳腺癌内分泌治疗相关的中度至重度血管舒缩症状-动脉网

Lynkuet™ (elinzanetant) approved in the EU for the treatment of moderate to severe vasomotor symptoms associated with menopause or endocrine therapy for breast cancer

拜耳等信源发布 2025-11-19 15:40



可切换为仅中文







November

十一月

2025

08:29 AM

早上08:29

Europe/Amsterdam

欧洲/阿姆斯特丹

Lynkuet™ (elinzanetant) approved in the EU for the treatment of moderate to severe vasomotor symptoms associated with menopause or endocrine therapy for breast cancer

Lynkuet™（elinzanetant）在欧盟获批用于治疗与更年期或乳腺癌内分泌治疗相关的中度至重度血管舒缩症状。

Not intended for U.S. and UK Media

不适用于美国和英国媒体

Summary

摘要

Elinzanetant, now approved in the EU under the brand name Lynkuet™ is a dual neurokinin (NK)-targeted therapy (NK-1 and NK-3 receptor antagonist) and the only hormone-free treatment for moderate to severe vasomotor symptoms (VMS; also known as hot flashes) associated with menopause or caused by adjuvant endocrine therapy (AET) related to breast cancer / European approval in these two indications is based on positive results from the OASIS Phase III program, comprising four clinical studies (OASIS-1-4), in which elinzanetant significantly reduced the frequency and severity of moderate to severe VMS in women experiencing menopause or receiving endocrine therapy for breast cancer and demonstrated a favorable safety profile.

Elinzanetant，现已在欧盟获批，商品名为Lynkuet™，是一种双重神经激肽（NK）靶向疗法（NK-1和NK-3受体拮抗剂），也是唯一一种不含激素的治疗中度至重度血管舒缩症状（VMS；也称为潮热）的药物，这些症状与更年期相关或由乳腺癌辅助内分泌治疗（AET）引起。/ 欧盟在两项适应症中的批准基于OASIS III期项目的积极结果，该项目包括四项临床研究（OASIS-1至4）。在这些研究中，elinzanetant显著减少了经历更年期或接受乳腺癌内分泌治疗的女性中度至重度VMS的频率和严重程度，并表现出良好的安全性。

Berlin, November 19, 2025 –

柏林，2025年11月19日 –

The European Commission has granted marketing authorization in the European Union (EU) for elinzanetant, under the brand name Lynkuet™. The compound is approved for the treatment of moderate to severe vasomotor symptoms (VMS; also known as hot flashes) associated with menopause or caused by adjuvant endocrine therapy (AET) related to breast cancer..

欧盟委员会已授予 elinzanetant（品牌名称：Lynkuet™）在欧盟 (EU) 的上市许可。该药物被批准用于治疗与更年期相关或由乳腺癌辅助内分泌治疗 (AET) 引发的中度至重度血管舒缩症状 (VMS；也称为潮热)。

“The European approval of Lynkuet™ brings a new option to women whose daily lives are disrupted by vasomotor symptoms,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, and Member of the Pharmaceutical Leadership Team at Bayer. “We understand how challenging and isolating these symptoms can be, often interfering with daily rhythm, personal productivity, and overall quality of life.

“Lynkuet™ 的欧洲批准为那些日常生活受到血管舒缩症状困扰的女性带来了新的选择，”拜耳公司执行副总裁、全球产品战略与商业化负责人以及制药领导团队成员克里斯汀·罗斯表示。“我们理解这些症状可能带来的挑战和孤立感，它们常常会干扰日常节奏、个人生产力以及整体生活质量。”

Our commitment is to support women with solutions that truly address their needs, helping them feel like them themselves again by supporting health and wellbeing at every stage.”.

我们的承诺是为女性提供真正满足她们需求的解决方案，通过在每个阶段支持健康和福祉，帮助她们重新找回自我。

By 2030, it is estimated that 1.2 billion women globally will be experiencing menopause.

到2030年，据估计全球将有12亿女性经历更年期。

VMS affect up to 80% of women during the menopausal transition.

在更年期过渡期间，VMS会影响高达80%的女性。

In Europe, approximately 40% of women report moderate to severe VMS,

在欧洲，大约40%的女性报告中度至重度的VMS，

highlighting the substantial burden of these symptoms on daily life and overall well-being.

突出了这些症状对日常生活和整体健康状况的沉重负担。

“Menopause symptoms, including hot flashes, can greatly affect women's quality of life,” said Nick Panay, Principal Investigator for OASIS-3, Consultant Gynecologist, Imperial College Healthcare NHS Trust, Professor of Practice, Imperial College London and Immediate Past President of the International Menopause Society.

“更年期症状，包括潮热，会极大地影响女性的生活质量，”OASIS-3 首席研究员、帝国理工学院医疗保健 NHS 信托的妇产科顾问医师、伦敦帝国理工学院实践教授、国际更年期协会前任主席 Nick Panay 表示。

“This approval is an important milestone in the area of menopause care as it expands therapeutic options for women experiencing distressing menopause symptoms with a novel targeted hormone-free treatment and facilitates healthcare professionals to achieve more personalized treatment.”.

“这一批准是更年期护理领域的一个重要里程碑，它为经历困扰性更年期症状的女性提供了一种新的无激素靶向治疗选择，并帮助医疗专业人员实现更加个性化的治疗。”

VMS may also be caused by endocrine therapy, for the treatment or prevention of breast cancer. Breast cancer remains the most common cancer diagnosed in women worldwide, with approximately 70% of cases categorized as hormone-receptor positive (HR+).

VMS 也可能由内分泌治疗引起，用于治疗或预防乳腺癌。乳腺癌仍然是全球女性中最常诊断的癌症，大约 70% 的病例被归类为激素受体阳性 (HR+)。

4,5

4.5

Endocrine therapy, an established treatment for women with HR+ breast cancer, can often result in VMS

内分泌治疗是针对HR+乳腺癌女性的既定治疗方法，但常常会导致VMS。

6,7

impacting quality of life and treatment adherence.

影响生活质量和治疗依从性。

“Menopausal symptoms are common side effects of endocrine therapy for breast cancer, frequently leading to treatment discontinuation, which highlights the importance of managing these symptoms in breast cancer care,” said Dr. Fatima Cardoso, Principal Investigator of OASIS-4, from Lisbon, Portugal. “With the approval of this hormone-free therapy, we now have the first approved treatment option for this indication that will help in addressing an important unmet medical need of women and improve their quality of life during this challenging time.”.

“绝经症状是乳腺癌内分泌治疗的常见副作用，常常导致治疗中断，这凸显了在乳腺癌护理中管理这些症状的重要性，”OASIS-4 首席研究员、来自葡萄牙里斯本的法蒂玛·卡多索博士说道。“随着这种不含激素的疗法获批，我们现在拥有了首个获批准的治疗选择，用于满足这一未被满足的重要医疗需求，帮助女性在此困难时期改善生活质量。”

The approval of elinzanetant in the EU is based on the positive results from the OASIS Phase III clinical development program, comprising OASIS-1, -2, -3 and -4, which met all primary endpoints and key secondary endpoints in all four studies and demonstrated a favorable safety profile. Data have been published in diverse medical journals: OASIS-1 and –2 in August 2024 in .

欧盟对elinzanetant的批准基于OASIS III期临床开发计划的积极结果，该计划包括OASIS-1、-2、-3和-4，所有四项研究均达到了所有主要终点和关键次要终点，并显示出良好的安全性。数据已发布在多种医学期刊上：OASIS-1和-2于2024年8月发布。

The Journal of the American Medical Association

美国医学会杂志

(JAMA)

（JAMA）

, OASIS-3 in

，OASIS-3 在

The Journal of the American Medical Association (JAMA) Internal Medicine

美国医学会杂志（JAMA）内科学

in September 2025

2025年9月

and OASIS-4 in the

OASIS-4 在

New England Journal of Medicine

新英格兰医学杂志

(NEJM) in June 2025.

2025年6月（NEJM）。

About elinzanetant (Lynkuet

关于elinzanetant（Lynkuet）

™

)

Elinzanetant is the first dual neurokinin (NK)-targeted therapy, (NK-1 and NK- 3 receptor antagonist), globally developed for the treatment of moderate to severe vasomotor symptoms (VMS; also known as hot flashes) associated with menopause or endocrine therapy (ET) for breast cancer, administered orally once daily.

Elinzanetant 是首个全球开发的双重神经激肽（NK）靶向治疗药物（NK-1 和 NK-3 受体拮抗剂），用于治疗中度至重度血管舒缩症状（VMS；也称为潮热），这些症状与绝经或乳腺癌的内分泌治疗（ET）相关，每日一次口服给药。

Increasing evidence indicates that hypothalamic neurons called kisspeptin, neurokinin B, and dynorphin (KNDy) neurons, expressing both NK-1 and NK-3 receptors and their ligands Substance P and NKB, play a role in thermoregulation. Declining estrogenic activity due to natural menopause or endocrine therapy leads to hyperactivity of KNDy neurons and dysregulation of the thermoregulatory center, resulting in VMS.

越来越多的证据表明，称为亲吻肽、神经激肽B和强啡肽（KNDy）的下丘脑神经元表达NK-1和NK-3受体及其配体P物质和NKB，在体温调节中起作用。由于自然绝经或内分泌治疗导致的雌激素活性下降会引起KNDy神经元过度活跃及体温调节中枢失调，从而导致血管舒缩症状（VMS）。

NK-1 receptors may also have a role in the cooling response through sweating and peripheral vasodilatation as well as on sleep disturbances..

NK-1受体也可能通过出汗和外周血管扩张参与冷却反应，以及对睡眠障碍产生影响。

Elinzanetant is approved under the brand name Lynkuet™ in Australia, Canada, the UK, the U.S., and Switzerland for the treatment of VMS associated with menopause and in the EU for the treatment of moderate to severe VMS associated with menopause or caused by adjuvant endocrine therapy (AET) related to breast cancer.

Elinzanetant在澳大利亚、加拿大、英国、美国和瑞士以品牌名Lynkuet™获批用于治疗与更年期相关的VMS，在欧盟获批用于治疗与更年期相关或由乳腺癌相关的辅助内分泌治疗（AET）引起的中度至重度VMS。

Submissions for marketing authorizations for elinzanetant are also ongoing in other markets around the world..

elinzanetant 的上市许可申请也正在全球其他市场进行中。

About the Elinzanetant clinical development program

关于Elinzanetant的临床开发计划

The Phase III clinical development program of elinzanetant, OASIS, comprises four Phase III studies: OASIS-1, -2, -3 and -4. OASIS-1 and -2 investigated the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause over 26 weeks and randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries.

Elinzanetant的III期临床开发项目OASIS包括四项III期研究：OASIS-1、-2、-3和-4。OASIS-1和-2研究评估了口服每日一次Elinzanetant在治疗与绝经相关的中度至重度血管舒缩症状（VMS）女性中的疗效和安全性，为期26周，并在15个国家的184个研究中心随机选取了396名和400名年龄在40至65岁之间的绝经后女性。

Patients in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks and patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks. OASIS-3 investigated the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause over 52 weeks and randomized 628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries.

Elinzanetant 组的患者每日一次接受 120 mg 的 elinzanetant，持续 26 周，而对照组的患者每日一次接受匹配的安慰剂，持续 12 周，随后接受 14 周的 120 mg 剂量 elinzanetant。OASIS-3 研究了 elinzanetant 在治疗与更年期相关的血管舒缩症状方面的疗效和安全性，为期 52 周，并在 9 个国家的 83 个研究中心将 628 名年龄在 40 至 65 岁之间的绝经后女性随机分组。

OASIS-4 is a double-blind, randomized, placebo-controlled multicenter study to investigate the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with endocrine therapy for treatment or prevention of hormone receptor positive (HR+) breast cancer over 52 weeks and optionally for an additional 2 years in women taking endocrine therapy, for treatment of breast cancer.

OASIS-4 是一项双盲、随机、安慰剂对照的多中心研究，旨在调查 elinzanetant 在治疗或预防激素受体阳性 (HR+) 乳腺癌的内分泌治疗过程中，针对与之相关的血管舒缩症状的疗效和安全性，研究周期为 52 周，并可选择在进行内分泌治疗的女性中延长额外 2 年用于乳腺癌治疗。

474 patients at 90 centers in 16 countries (excluding the US) were randomized..

在16个国家（不包括美国）的90个中心的474名患者被随机分配。

About Menopause

关于更年期

By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million women entering this phase each year. Menopause is a phase in women’s lives, related to the progressive decline of ovarian function usually occurring in their late 40s or early 50s.

到2030年，全球经历更年期的女性人口预计将增加到12亿，每年有4700万女性进入这一阶段。更年期是女性生命中的一个阶段，通常发生在她们的40岁末或50岁初，与卵巢功能的逐渐衰退有关。

Menopause symptoms can also be a consequence of surgical or medical treatment such as breast cancer treatment. The most frequently reported and disruptive menopause symptoms are VMS and sleep disturbances, which can substantially affect a woman’s health, quality of life and work productivity. Addressing disruptive menopause symptoms is key to maintaining functional ability and quality of life which is highly relevant from both a healthcare and socio-economic perspective..

更年期症状也可能是外科或医疗治疗（如乳腺癌治疗）的结果。最常报告且影响最大的更年期症状是血管舒缩症状（VMS）和睡眠障碍，这些症状会严重影响女性的健康、生活质量和工作效率。解决影响大的更年期症状对于维持功能能力和生活质量至关重要，这在医疗保健和社会经济方面都具有高度相关性。

About Women’s Healthcare at Bayer

关于拜耳的女性医疗保健

Women’s Health is in Bayer’s DNA. As a global leader in women’s healthcare Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases.

女性健康深植于拜耳的DNA中。作为全球女性医疗保健领域的领导者，拜耳长期致力于通过推进创新治疗方案组合来实现科学改善生活的目标。拜耳提供多种有效的短效和长效避孕方法，以及针对更年期管理和妇科疾病的治疗方案。

Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives.

拜耳还在专注于创新方案，以应对全球女性未被满足的医疗需求，并拓宽如更年期等方面的治疗选择。此外，拜耳计划到2030年，通过资助多利益相关方的援助项目来加强能力建设，并确保提供价格合理的现代避孕药具，从而使每年1亿名低收入和中等收入国家的女性获得计划生育服务。

This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations..

这是自2020年以来全面可持续发展措施和承诺的一部分，并与联合国的可持续发展目标一致。

About Bayer

关于拜耳

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

拜耳是一家在全球范围内拥有医疗保健和营养生命科学领域核心竞争力的企业。秉承“人人健康，无饥饿”的使命，公司通过支持应对不断增长和老龄化的全球人口所带来的重大挑战，设计其产品和服务以帮助人类和地球繁荣发展。

Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros.

拜耳致力于通过其业务推动可持续发展并产生积极影响。同时，集团旨在通过创新和增长提高盈利能力并创造价值。拜耳品牌在全球范围内代表信任、可靠性和质量。在2024财年，该集团拥有约93,000名员工，销售额达466亿欧元。

R&D expenses amounted to 6.2 billion euros. For more information, go to .

研发费用达62亿欧元。欲了解更多信息，请访问。

www.bayer.com

。

Find more information at

更多信息请访问

https://pharma.bayer.com

关注我们的Facebook：

http://www.facebook.com/bayer

Forward-Looking Statements

前瞻性声明

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here.

本发布可能包含基于拜耳管理层当前假设和预测的前瞻性声明。各种已知和未知的风险、不确定性和其他因素可能导致公司的实际未来结果、财务状况、发展或业绩与这里提供的估计存在重大差异。

These factors include those discussed in Bayer’s public reports which are available on the Bayer website at .

这些因素包括拜耳公开报告中讨论的因素，该报告可在拜耳网站上查阅。

www.bayer.com

. The company assumes no liability whatsoever to update these forward-looking statements or to conform

公司不承担任何更新这些前瞻性声明或使其符合的义务。

them to future events or developments.

将它们应用于未来的事件或发展。

References:

参考文献：

1 Hill K. The demography of menopause. Maturitas. 1996 Mar 1;23(2):113-27.

1 Hill K. 绝经期的人口统计学。《成熟期》。1996年3月1日；23(2):113-27。

2 Gold EB, et al. Longitudinal Analysis of the Association Between Vasomotor Symptoms and Race/Ethnicity Across the Menopausal Transition: Study of Women’s Health Across the Nation. American journal of public health. 2006 Jul;96(7):1226-35.

2 Gold EB, 等。绝经过渡期间血管舒缩症状与种族/民族关联的纵向分析：全国女性健康研究。《美国公共卫生杂志》。2006年7月；96(7):1226-35。

3 Nappi RE, et al. Global cross-sectional survey of women with vasomotor symptoms associated with menopause: prevalence and quality of life burden. Menopause. 2021 Aug 1;28(8):875-82.

3 Nappi RE, 等。全球横断面调查：与更年期相关的血管舒缩症状在女性中的患病率及生活质量负担。《更年期》。2021年8月1日；28（8）：875-82。

4 Breast cancer. World Health Organization. 2024. Available at:

4 乳腺癌。世界卫生组织。2024。可访问于：

https://www.who.int/news-room/fact-sheets/detail/breast-cancer

. Last accessed: September 2025.

最后访问时间：2025年9月。

5 Selli C, et al. Accurate prediction of response to endocrine therapy in breast cancer patients: current and future biomarkers. Breast Cancer Research. 2016 Dec;18:1-0.

5 Selli C，等。乳腺癌患者内分泌治疗反应的准确预测：当前和未来的生物标志物。《乳腺癌研究》。2016年12月；18:1-0。

6 Burstein HJ, et al. Adjuvant Endocrine Therapy for Women With Hormone Receptor-Positive Breast Cancer: ASCO Clinical Practice Guideline Focused Update. Journal of Clinical Oncology. 2019 Feb 10;37(5):423-38.

6 Burstein HJ, 等。女性激素受体阳性乳腺癌的辅助内分泌治疗：ASCO临床实践指南重点更新。《临床肿瘤学杂志》。2019年2月10日；37(5):423-38。

7 Cucciniello L, et al. Estrogen deprivation effects of endocrine therapy in breast cancer patients: Incidence, management and outcome. Cancer Treatment Reviews. 2023 Nov 1;120:102624.

7 Cucciniello L, 等。乳腺癌患者内分泌治疗的雌激素剥夺效应：发生率、管理及结果。《癌症治疗评论》。2023年11月1日；120:102624。

8 Pinkerton JV, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials. JAMA. 2024 Oct 22;332(16):1343-54.

8 Pinkerton JV, 等。Elinzanetant 治疗与更年期相关的血管舒缩症状：OASIS 1 和 2 随机临床试验。《美国医学会杂志》。2024 年 10 月 22 日；332(16):1343-54。

9 Panay N, et al. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: A Phase 3 Randomized Clinical Trial. JAMA Internal Medicine. 2025 Sep 8.

9 Panay N, 等。Elinzanetant用于治疗与更年期相关的血管舒缩症状：一项三期随机临床试验。《美国医学会内科杂志》。2025年9月8日。

10 Cardoso F, et al. Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer. New England Journal of Medicine. 2025 Jun 2.

10 Cardoso F, 等。Elinzanetant 用于乳腺癌内分泌治疗引起的血管舒缩症状。《新英格兰医学杂志》。2025年6月2日。

Contacts

联系人

Katja Wiggers

卡特娅·维格斯

Women's Healthcare

妇女保健

katja.wiggers@bayer.com

+49 30 221541614

Contact for investor inquiries: Bayer Investor Relations Team