Bayer today announced that the Medicines and Healthcare products Regulatory Agency (MHRA, regulatory authority in the UK) has authorized the use of elinzanetant, the first dual neurokinin NK)-targeted therapy (NK-1 and NK-3 receptor antagonist) under the brand name Lynkuet™ (Lynkuet

拜耳今天宣布，英国药品和健康产品管理局（MHRA）已授权使用 elinzanetant，这是首个双重神经激肽 NK 靶向疗法（NK-1 和 NK-3 受体拮抗剂），品牌名为 Lynkuet™（Lynkuet）。

in UK) for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause in the United Kingdom.

在英国用于治疗与更年期相关的中度至重度血管舒缩症状（VMS，也称为潮热）。

“This first approval worldwide marks a significant milestone for our hormone-free treatment elinzanetant to manage some of the most disruptive menopausal symptoms,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer.

“这一全球首次批准标志着我们无激素治疗药物elinzanetant在管理一些最具破坏性的更年期症状方面迈出了重要的里程碑，”拜耳制药执行副总裁、全球产品战略与商业化主管及制药领导团队成员克里斯汀·罗斯表示。

“It highlights Bayer’s longstanding commitment to advance women’s health, and we are looking forward to bringing this option to many more women around the world.”.

“这突显了拜耳长期以来对促进女性健康的承诺，我们期待着将这一选择带给世界各地更多的女性。”

“Menopausal symptoms, such as hot flashes, can have a profound impact on the quality of life for women. They are not just physical discomforts; they can significantly disrupt daily activities, sleep and emotional well-being,” said Dr Paula Briggs, Consultant Gynaecologist in Sexual and Reproductive Health in Liverpool Women’s NHS Foundation Trust, Immediate Past Chair of the British Menopause Society.

“更年期症状，如潮热，会对女性的生活质量产生深远的影响。它们不仅仅是身体上的不适，还可能严重扰乱日常活动、睡眠和情绪健康，”利物浦妇女NHS基金会信托的性与生殖健康顾问妇科医生保拉·布里吉斯博士说道，她也是英国更年期协会的前任主席。

“I welcome expanded therapeutic options that address the diverse needs and preferences of women going through menopause. Physicians now have a new hormone-free treatment option that offers an alternative for tailoring treatment plans, helping women manage their symptoms and potentially enhance their overall quality of life during this important transition.”.

“我欢迎更多能够满足经历更年期女性多样化需求和偏好的治疗选择。医生现在拥有一种新的无激素治疗方案，为制定个性化治疗计划提供了替代选择，帮助女性管理她们的症状，并有可能提高她们在这一重要过渡期的整体生活质量。”

The marketing authorization in the UK is the first approval worldwide and based on positive results from the Phase III studies OASIS-1, -2 and -3 evaluating the efficacy and safety profile of elinzanetant. Elinzanetant met all primary endpoints in all three studies and demonstrated a favorable safety profile..

英国的上市授权是全球首个批准，基于评估 elinzanetant 的疗效和安全性特征的 III 期研究 OASIS-1、-2 和 -3 的积极结果。Elinzanetant 在所有三项研究中均达到了所有主要终点，并表现出良好的安全性。

In OASIS-1 and -2

在OASIS-1和-2中

, elinzanetant significantly reduced mean frequency and severity of moderate to severe VMS associated with menopause compared to placebo at weeks 4 and 12. Efficacy was maintained with over 80% of participants in the elinzanetant group achieving at least a 50% reduction in VMS frequency by week 26, including those who switched from placebo to elinzanetant after week 12.

Elinzanetant在第4周和第12周显著降低了与更年期相关的中度至重度血管舒缩症状（VMS）的平均频率和严重程度，优于安慰剂。在第26周时，超过80%的Elinzanetant组参与者实现了VMS频率至少减少50%，其中包括那些在第12周后从安慰剂转为Elinzanetant的参与者，疗效得以维持。

Both trials also achieved all three key secondary endpoints showing a statistically significant mean reduction in the frequency of VMS from baseline to week 1, as well as statistically significant improvements in sleep disturbances and menopause-related quality of life compared to placebo..

两项试验还达到了所有三个关键的次要终点，结果显示，与安慰剂相比，从基线到第1周，VMS频率平均显著减少，同时在睡眠障碍和更年期相关生活质量方面也显示出统计学上的显著改善。

In OASIS-3, elinzanetant demonstrated a statistically significant mean reduction in the frequency of moderate to severe VMS from baseline to week 12 compared to placebo. The VMS reductions were maintained throughout the study duration. OASIS-3 reinforced the findings from OASIS-1 and -2, reporting a sustained benefit and safety profile over 52 weeks with the most frequently reported adverse with elinzanetant versus placebo being headache, fatigue and somnolence (also known as drowsiness)..

在OASIS-3试验中，与安慰剂相比，elinzanetant在第12周时显示出从基线到中度至重度VMS频率的统计学显著平均减少。VMS的减少在整个研究期间得以维持。OASIS-3加强了OASIS-1和-2的结果，报告了在52周内持续的益处和安全性，其中elinzanetant相对于安慰剂最常见的不良反应是头痛、疲劳和嗜睡（也称为困倦）。

Based on the positive results from the Phase III clinical development program, submissions for marketing authorizations for elinzanetant are also ongoing in the US, the EU and other markets around the world.

基于 III 期临床开发计划的积极结果，elinzanetant 在美国、欧盟和世界各地其他市场的上市授权申请也在进行中。

About elinzanetant

关于elinzanetant

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 是全球首个用于治疗中度至重度血管舒缩症状（VMS；也称为潮热）的双重神经激肽（NK）靶向疗法（NK-1 和 NK-3 受体拮抗剂），适用于更年期或乳腺癌内分泌治疗（ET）相关症状，每日一次口服给药。

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

越来越多的证据表明，表达NK-1和NK-3受体及其配体（称为吻素、神经激肽B和强啡肽）的下丘脑神经元（KNDy神经元）在体温调节中起作用。由于自然绝经或雌激素治疗导致的雌激素活性下降会引起KNDy神经元的过度活跃及体温调节中枢的失调，从而引发血管舒缩症状（VMS）。

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

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

The compound has been authorized under the brand name Lynkuet™ in the UK in July 2025.

该化合物已于2025年7月在英国以Lynkuet™品牌名称获得授权。

It is under regulatory review in the Unites States, countries of the European Union and other markets around the world.

它正在美国、欧盟各国以及世界其他市场接受监管审查。

About the Phase III OASIS-1, -2 and -3 studies in elinzanetant

关于elinzanetant的III期OASIS-1、-2和-3研究

The UK approval of elinzanetant is supported by three Phase III clinical studies – OASIS-1, -2 and -3. OASIS11 and -2 investigated the efficacy and safety profile 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.

英国对elinzanetant的批准得到了三项III期临床研究的支持——OASIS-1、-2和-3。OASIS-1和-2研究评估了口服elinzanetant每日一次在与绝经相关的中度至重度VMS女性中的疗效和安全性，研究历时26周，纳入了来自15个国家184个研究中心的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 profile of elinzanetant versus placebo for the treatment of moderate to severe VMS associated with menopause over 52 weeks in postmenopausal women, without a minimum number of VMS for inclusion.

elinzanetant组患者每日一次接受120 mg剂量的elinzanetant，持续26周，而对照组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研究在绝经后女性中，评估了elinzanetant与安慰剂相比治疗与绝经相关的中度至重度血管舒缩症状（VMS）的疗效和安全性，持续52周，且没有设定纳入所需的最低VMS次数。

628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries were randomized..

40至65岁的628名绝经后妇女随机分布在9个国家的83个地点。

About Vasomotor Symptoms

关于血管舒缩症状

Vasomotor symptoms (VMS; also referred to as hot flashes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons. This is due to a decrease of estrogen, which can result from the progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or medical treatment such as endocrine therapy for breast cancer..

血管舒缩症状（VMS；也称为潮热）是由于KNDy神经元肥大介导的体温调节通路过度激活所导致。这归因于雌激素的减少，而雌激素的减少可能是由于自然绝经引起的卵巢功能逐渐减退，或因医疗干预如双侧卵巢切除术，或诸如乳腺癌内分泌治疗等医学治疗所致。

VMS are reported by up to 80% of women at some point during the menopausal transition

在更年期过渡期间，高达80%的女性在某个时间点报告出现VMS。

and are one of the leading causes for seeking medical attention during this phase of a woman’s life.

是女性在这个阶段寻求医疗关注的主要原因之一。

Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact on quality of life.

超过三分之一的绝经后女性报告有严重症状，这些症状可能在最后一次月经周期结束后持续十年甚至更久，并对生活质量产生显著影响。

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.

到2030年，预计全球经历更年期的女性人口将增加到12亿，每年有4700万女性进入这一阶段。

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.

绝经是女性生命中的一个阶段，通常发生在她们的40多岁末或50多岁初，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.

更年期症状也可能是手术或医疗治疗（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，这些症状会显著影响女性的健康、生活质量和工作效率。

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.

解决更年期破坏性症状是维持功能能力和生活质量的关键，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.

妇女健康深植于拜耳的DNA中。作为全球女性医疗保健的领导者，拜耳长期致力于通过推进一系列创新治疗方案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，以及用于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.

拜耳还在关注创新方案，以满足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，使低收入和中等收入国家每年1亿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相一致。

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.

拜耳是一家在医疗保健和营养等生命科学领域具有核心竞争力的全球性企业。秉承“人人健康，无人饥饿”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升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。