Approval granted by Japan's Ministry of Health, Labour and Welfare (MHLW)

获得日本厚生劳动省（MHLW）批准

Eptinezumab is the only intravenous (IV) CGRP-targeted preventive treatment approved for the prevention of migraine attacks in adults and launched in over 30 countries worldwide

Eptinezumab 是唯一一种静脉注射（IV）的靶向 CGRP 预防性治疗药物，已获批用于成人偏头痛发作的预防，并在全球 30 多个国家上市。

Authorization supported by the Phase III SUNRISE trial and the SUNSET long-term extension study in Japanese patients

III期SUNRISE试验及日本患者长期延伸研究SUNSET支持的授权

Building on 25 years of commitment to patients and brain health in Japan, the approval paves the way for Lundbeck's first launch in Japan as Marketing Authorization holder, enabling Lundbeck to operate independently on the Japanese market

基于在日本对患者和脑部健康领域25年的承诺，此次批准为灵北制药以上市许可持有人身份在日本首次推出产品铺平了道路，使灵北制药能够在日本市场独立运营。

VALBY, Denmark

丹麦，瓦尔比

,

，

Sept. 16, 2026

2026年9月16日

/PRNewswire/ -- H. Lundbeck A/S (Lundbeck) today announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan has granted marketing authorization for eptinezumab for the prevention of migraine attacks in adults, marking an important milestone for patients in Japan and for Lundbeck's continued growth in Asia..

/美通社/ -- H. Lundbeck A/S（Lundbeck）今日宣布，日本厚生劳动省（MHLW）已批准eptinezumab用于成人偏头痛发作的预防性治疗，这标志着日本患者以及Lundbeck在亚洲的持续增长迈出了重要一步。

Migraine is a debilitating neurological disease characterized by recurrent attacks of severe headache often accompanied by nausea, vomiting, and sensitivity to light and sound. In Japan, migraine affects an estimated 8.4%–11.0% of the population

偏头痛是一种使人衰弱的神经系统疾病，其特征为反复发作的剧烈头痛，常伴有恶心、呕吐以及对光和声音敏感。在日本，估计有8.4%–11.0%的人口受到偏头痛的影响。

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and is the fourth leading cause of years lived with disability.

并且是导致残疾生存年数第四高的原因。

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Beyond the physical symptoms, migraine significantly affects daily functioning, quality of life, work productivity and life course.

除了身体症状外，偏头痛还严重影响日常功能、生活质量、工作效率以及人生轨迹。

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Migraine is estimated to cost the Japanese economy US$ 3 billion every year in lost productivity.

据估计，偏头痛每年给日本经济造成的生产力损失达30亿美元。

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'This approval represents a significant advancement for people living with migraine in Japan, where the disease continues to place a substantial burden on patients, families, and society,' said Tarek Samad, EVP and Head of Research and Development at Lundbeck. 'Eptinezumab is a differentiated IV CGRP-targeted therapy that offers adults living with migraine an important new treatment option, and we are proud to bring this innovative medicine to patients in Japan.

“这一批准对于日本的偏头痛患者而言是一项重大进展，在该国，偏头痛继续给患者、家庭和社会带来沉重负担。” Lundbeck 执行副总裁兼研发负责人 Tarek Samad 表示，“Eptinezumab 是一种具有差异化的靶向 CGRP 的静脉输注疗法，为成年偏头痛患者提供了一个重要的新治疗选择。我们很自豪能将这款创新药物带给日本的患者。”

This approval also marks an exciting new chapter for Lundbeck Japan as we prepare for our first independent launch, building on 25 years of commitment to patients and brain health in the country.'.

此次批准也标志着灵北日本迎来了一个令人振奋的新篇章，为我们即将进行的首次独立上市做好准备，并在此基础上延续我们在过去25年里对患者和脑部健康的承诺。

Eptinezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) and was developed for IV administration as a preventive treatment for migraine.

Eptinezumab是一种人源化单克隆抗体，可结合降钙素基因相关肽（CGRP），并开发为静脉给药的偏头痛预防性治疗药物。

The Japanese marketing authorization is supported by the global clinical development program for eptinezumab, including the Phase III PROMISE-1, PROMISE-2 and DELIVER trials, together with data from the Phase III SUNRISE trial, which evaluated efficacy and safety in a predominantly Asian population with chronic migraine..

日本的上市许可得到了eptinezumab全球临床开发项目的支持，包括III期PROMISE-1、PROMISE-2和DELIVER试验，以及来自III期SUNRISE试验的数据，该试验评估了以亚洲人群为主的慢性偏头痛患者的疗效和安全性。

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The application was further supported by the Phase III SUNSET long-term extension study conducted specifically in Japanese patients to evaluate the long-term safety of eptinezumab.

该申请还得到了III期SUNSET长期扩展研究的支持，该研究专门在日本患者中开展，旨在评估依普奈珠单抗的长期安全性。

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Eptinezumab was first approved by the U.S. Food and Drug Administration in 2020 for the preventive treatment of migraine in adults, followed by additional approvals including in the European Union and most recently South Korea. It has since been launched in more than 30 markets worldwide.

Eptinezumab 于2020年首次获得美国食品药品监督管理局批准，用于成人偏头痛的预防性治疗，随后又在包括欧盟以及最近的韩国在内的多个地区获得额外批准。目前，该药已在全球30多个市场上市。

About migraine

关于偏头痛

Migraine is a complex and disabling neurological disease characterized by recurrent attacks of severe headache typically accompanied by an array of symptoms, including nausea, vomiting, and sensitivity to light or sound. Not only is headache painful, but migraine also imposes both a social and financial burden.

偏头痛是一种复杂且致残的神经系统疾病，其特征是反复发作的严重头痛，通常伴随一系列症状，包括恶心、呕吐以及对光或声音敏感。头痛不仅带来痛苦，偏头痛还会造成社会和经济负担。

Migraine can have a profound impact on daily functioning, work productivity, family and social relationships and quality of life..

偏头痛会对日常功能、工作效率、家庭与社交关系以及生活质量产生深远影响。

Migraine is one of the most prevalent neurological diseases worldwide and remains a leading cause of disability, particularly among people under the age of 50.

偏头痛是全球最普遍的神经系统疾病之一，仍然是导致残疾的主要原因，尤其是在50岁以下的人群中。

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As migraine frequency and severity increase, attacks may become harder to control, contributing to greater disease burden and, without appropriate preventive management, progression to chronic migraine.

随着偏头痛发作频率和严重程度的增加，发作可能变得更难控制，从而加重疾病负担，并在缺乏适当预防性管理的情况下，进展为慢性偏头痛。

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About Vyepti® (eptinezumab)

关于 Vyepti®（eptinezumab）

Eptinezumab is a humanized mAb that binds to CGRP which was designed for IV administration. The efficacy and safety of eptinezumab were evaluated in two Phase III clinical trials, PROMISE-1 in episodic migraine

Eptinezumab是一种人源化单克隆抗体，可与CGRP结合，专为静脉给药而设计。在两项III期临床试验中评估了Eptinezumab的疗效和安全性，其中PROMISE-1针对发作性偏头痛

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and PROMISE-2 in chronic migraine.

以及PROMISE-2在慢性偏头痛中的应用。

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In both trials, eptinezumab met its primary endpoint of decrease in monthly migraine days (MMDs) over weeks 1-12.

在两项试验中，eptinezumab均达到了其主要终点，即在第1至12周内减少每月偏头痛天数（MMDs）。

The safety of eptinezumab has been evaluated in more than 5,000 adult patients with migraine who received at least one dose. Common adverse reactions in the placebo-controlled clinical trials for the preventive treatment of migraine were hypersensitivity and infusion-related reactions.

依普奈珠单抗的安全性已在超过5,000名至少接受过一次给药的成年偏头痛患者中进行了评估。在用于偏头痛预防性治疗的安慰剂对照临床试验中，常见的不良反应包括超敏反应和输注相关反应。

VYEPTI® (eptinezumab-jjmr) was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020, and in January 2022, eptinezumab was granted marketing authorization by the European Commission (EC) for the prophylaxis of migraine in adults who have at least four migraine days per month.

VYEPTI®（eptinezumab-jjmr）于2020年2月获得美国食品药品监督管理局（FDA）批准，用于成人偏头痛的预防性治疗；2022年1月，eptinezumab获得欧盟委员会（EC）的上市许可，用于每月至少有四天偏头痛的成人患者的偏头痛预防。

In Japan, eptinezumab is approved for the prevention of migraine attacks in adults. Today, eptinezumab is launched in more than 30 markets worldwide..

在日本，Eptinezumab 被批准用于预防成人偏头痛发作。目前，Eptinezumab 已在全球30多个市场上市。

Contacts

联系人

Anders Crillesen

安德斯·克里勒森

Jens Høyer

延斯·霍耶

Head of Media Relations, Corp. Communication

媒体关系主管，企业传播部

Vice President, Head of Investor Relations

副总裁，投资者关系负责人

[email protected]

[email protected]

[email protected]

[email protected]

+45 27 79 12 86

+45 27 79 12 86

+45 30 83 45 01

+45 30 83 45 01

About H. Lundbeck A/S

关于 H. Lundbeck A/S

Lundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases.

灵北制药是一家专注于脑部健康的生物制药公司。凭借在神经科学领域超过70年的经验，我们致力于改善神经和精神疾病患者的生活。

Brain disorders affect a large part of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments.

脑部疾病影响着全球大量人口，其影响波及整个社会。随着我们对大脑生物学的理解迅速加深，我们有责任通过好奇地探索新的治疗机会来推动大脑健康的发展。

As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology..

作为一家专注的创新企业，我们致力于通过研发项目应对一些最复杂的神经系统挑战。我们开发变革性药物，面向那些几乎没有或完全没有治疗选择的患者群体，并依托我们在精神病学和神经学领域的深厚积淀，向神经专科和神经罕见病领域拓展。

We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole.

我们致力于消除污名化，并采取行动改善健康公平。我们通过为患者、其家庭以及整个社会作出积极贡献，努力为股东创造长期价值。

Lundbeck has more than 5,000 employees in more than 20 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site

灵北制药在全球20多个国家拥有5,000多名员工，产品销往80多个国家。如需更多信息，欢迎访问我们的企业网站。

www.lundbeck.com

www.lundbeck.com

and connect with us via

并通过以下方式与我们联系

LinkedIn

领英

.

。

References:

参考文献：

Sakai F, Igarashi H. Cephalalgia. 1997;17(1):15-22

Sakai F, Igarashi H. 《头疼痛》. 1997;17(1):15-22

Takeshima T, et al. J Headache Pain. 2025;26(1):275

竹岛 T 等. 《头痛与疼痛杂志》. 2025;26(1):275

Sakai F (2010) Olesen J, Ramadan N (eds) Headache care, research and education worldwide, vol 17. Oxford University Press, New York, pp 35–40

Sakai F（2010）载于：Olesen J，Ramadan N（编）《全球头痛诊疗、研究与教育》，第17卷。牛津大学出版社，纽约，第35–40页

Yu S, et al. Cephalalgia. 2025;45(10):3331024251386095

Yu S, 等. 《头ache》. 2025;45(10):3331024251386095

Steiner TJ, et al. J Headache Pain. 2018;19(1):17

Steiner TJ，等. 《头痛与疼痛杂志》. 2018;19(1):17

Leonardi M, et al. J Headache Pain. 2005; 6(6):429– 440

Leonardi M 等. 《头痛与疼痛杂志》. 2005; 6(6):429–440

Lipton RB, et al. J Neurol. 2023;270(12);5692–5710

Lipton RB 等. 《神经病学杂志》. 2023;270(12):5692–5710

Ashina M, et al. Cephalalgia. 2020;40(3):241-254

Ashina M 等. 《头 Cephalalgia》. 2020;40(3):241-254

Lipton RB, et al. Neurology. 2020;94(13):e1365-e1377

Lipton RB 等. 《神经病学》. 2020;94(13):e1365-e1377

CONTACT:

联系方式：

H. Lundbeck A/S

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Denmark

丹麦瓦尔比，邮编2500，奥蒂利亚街9号

+45 3630 1311

+45 3630 1311

[email protected]

[email protected]

This information was brought to you by Cision

本信息由 Cision 提供

http://news.cision.com

http://news.cision.com

https://news.cision.com/h--lundbeck-a-s/r/lundbeck-receives-marketing-authorization-for-vyepti---eptinezumab--in-japan-for-the-prevention-of-m,c4396357

https://news.cision.com/h--lundbeck-a-s/r/lundbeck-receives-marketing-authorization-for-vyepti---eptinezumab--in-japan-for-the-prevention-of-m,c4396357

The following files are available for download:

以下文件可供下载：

https://mb.cision.com/Main/18215/4396357/4271814.pdf

https://mb.cision.com/Main/18215/4396357/4271814.pdf

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