Eisai Co., Ltd. and Biogen Inc. announced today that anti-Aβ protofibril* antibody “LEQEMBI®”, recently introduced by the National Healthcare Security Administration (NHSA) of China. The inclusion of LEQEMBI in this list marks a meaningful step toward expanding access to early Alzheimer’s Disease (AD) treatment in China..

卫材株式会社和百健公司今天宣布，抗Aβ原纤维*抗体“LEQEMBI®”最近被中国国家医疗保障局（NHSA）纳入。LEQEMBI被列入此名单标志着在中国扩大早期阿尔茨海默病（AD）治疗可及性方面迈出了有意义的一步。

The Commercial Insurance Innovative Drug List is based on new policies of the Chinese government to support the development and access of innovative medicines. The list aims to help narrow the coverage gap between the basic reimbursement system under the National Reimbursement Drug List (NRDL) and innovative medicines that address areas of significant unmet need.

商业保险创新药清单基于中国政府支持创新药物发展和可及性的新政策。该清单旨在帮助缩小国家基本报销药品目录（NRDL）下的基本报销体系与满足重大未满足需求的创新药物之间的覆盖差距。

Based on the Commercial Insurance Innovative Drug List, Commercial insurance companies will discuss and reach the agreement with pharmaceutical companies regarding coverage details, and develop insurance products focusing on the listed medicines. The Commercial Insurance Innovative Drug List is scheduled to take effect on January 1, 2026..

基于商业保险创新药清单，商业保险公司将与药企商讨并达成覆盖细节的协议，并开发专注于清单内药品的保险产品。商业保险创新药清单预计将于2026年1月1日生效。

Eisai estimates that there were 17 million patients with MCI or mild dementia due to AD in China in 2024, which is expected to increase with the aging of the population.

卫材估计，2024年中国因阿尔茨海默病导致的轻度认知障碍或轻度痴呆患者达1700万，随着人口老龄化，这一数字预计还会增加。

Eisai launched LEQEMBI in China in June 2024 and has delivered the product in the private market.

卫材于2024年6月在中国推出了LEQEMBI，并已在私营市场交付该产品。

Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. Eisai will distribute the product in China and will conduct information provision activities through specialized Medical Representatives..

卫材在全球范围内主导LEQEMBI的开发和监管提交工作，卫材和渤健共同商业化和推广该产品，卫材拥有最终决策权。卫材将在中国分销该产品，并通过专业的医药代表开展信息提供活动。

*Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition.1 Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells.

原纤维被认为对AD发生时的脑损伤有贡献，被认为是Aβ最具毒性的一种形式，在与这一渐进性、衰弱性疾病相关的认知衰退中起主要作用。原纤维会导致脑神经元损伤，进而通过多种机制对认知功能产生负面影响，不仅增加不溶性Aβ斑块的形成，还加剧对脑细胞膜及神经细胞间或神经细胞与其他细胞间传递信号的连接的直接损害。

It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.2.

人们认为，减少原纤维的形成可能通过减少对大脑神经元的损伤和认知功能障碍来预防AD的进展。

Media Contacts

媒体联系人

Eisai Co., Ltd.

卫材株式会社

Public Relations Department

公共关系部

TEL: +81 (0)3-3817-5120

电话：+81 (0)3-3817-5120

Eisai Europe, Ltd.

卫材欧洲有限公司

EMEA Communications Department

欧洲、中东和非洲通信部

+44 (0) 797 487 9419

+44 (0) 797 487 9419

Emea-comms@eisai.net

欧洲、中东、非洲通信@eisai.net

Eisai Inc. (U.S.)

卫材公司（美国）

Libby Holman

利比·霍尔曼

+1-201-753-1945

+1-201-753-1945

Libby_Holman@Eisai.com

Libby_Holman@Eisai.com

Biogen Inc.

百健公司

Madeleine Shin

马德琳·辛

+1-781-464-3260

+1-781-464-3260

public.affairs@biogen.com

公共事务@biogen.com

Investor Contats

投资者联系

Eisai Co., Ltd.

卫材株式会社

Investor Relations Department

投资者关系部

TEL: +81 (0) 3-3817-5122

电话：+81 (0) 3-3817-5122

Biogen Inc.

百健公司

Tim Power

蒂姆·鲍尔

+ 1-781-464-2442

+ 1-781-464-2442

IR@biogen.com

IR@biogen.com

Notes to Editors

编辑须知

1.  About LEQEMBI (generic name: lecanemab, Chinese brand name: 乐意保)

1. 关于LEQEMBI（通用名：lecanemab，中文商品名：乐意保）

Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Lecanemab has been approved in 51 countries and is under regulatory review in 9 countries.

Lecanemab 是卫材和 BioArctic 战略研究联盟的成果。它是一种人源化的免疫球蛋白伽马（IgG1）单克隆抗体，针对β淀粉样蛋白（Aβ）的聚集可溶性（原纤维）和不溶性形式。Lecanemab 已在 51 个国家获得批准，并正在另外 9 个国家接受监管审查。

Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in the U.S., China, the UK, and others, and applications have been filed in 4 countries and regions. The U.S. FDA approved Eisai’s Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025.

在最初阶段每两周治疗一次，持续18个月后，美国、中国、英国和其他国家批准了每四周一次的静脉（IV）维持剂量治疗，且已在4个国家和地区提交了申请。美国食品药品监督管理局（FDA）于2025年8月批准了卫材公司关于LEQEMBI IQLIK皮下维持剂量的生物制品许可申请（BLA）。

A rolling Supplemental Biologics License Application (sBLA) for initiation treatment was initiated under Fast Track status in September 2025, and completed in November 2025. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted..

2025年9月，启动治疗的滚动补充生物制品许可申请（sBLA）以快速通道状态开始，并于2025年11月完成。2025年11月，提交了在日本使用的皮下注射制剂的申请。

Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen.

自2020年7月以来，针对临床前阿尔茨海默病（AD）患者，即那些在临床上正常且大脑中具有中等或较高水平β淀粉样蛋白的个体，3期临床研究（AHEAD 3-45）正在进行中。AHEAD 3-45是一项公私合作项目，由美国国家老龄化研究所（隶属于美国国立卫生研究院）、卫材（Eisai）和渤健（Biogen）共同资助，阿尔茨海默病临床试验联盟提供在美国进行AD及相关痴呆学术临床试验的基础设施支持。

Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy..

自2022年1月以来，由华盛顿大学圣路易斯分校医学院主导的显性遗传阿尔茨海默病网络试验单位（DIAN-TU）开展的针对显性遗传阿尔茨海默病（DIAD）的Tau NexGen临床研究正在进行中，并将lecanemab作为基础抗淀粉样蛋白疗法。

2. About the Collaboration between Eisai and Biogen for AD

2. 关于卫材和百健在阿尔茨海默病方面的合作

Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority..

自2014年以来，卫材和渤健一直在合作开发和商业化阿尔茨海默病治疗药物。卫材在全球范围内主导了lecanemab的开发和监管提交，两家公司共同商业化和推广该产品，卫材拥有最终决策权。

3.  About the Collaboration between Eisai and BioArctic for AD

关于卫材和BioArctic在AD方面的合作

Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015..

自2005年以来，卫材和BioArctic就阿尔茨海默病（AD）治疗药物的开发和商业化进行了长期合作。根据2007年12月与BioArctic达成的协议，卫材获得了研究、开发、制造和销售lecanemab用于治疗AD的全球权利。关于lecanemab备用抗体的开发和商业化协议于2015年5月签署。

4. About Eisai Co., Ltd.

4. 关于卫材株式会社

Eisai's Corporate Concept is 'to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.' Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities.

卫材的公司理念是“首先考虑患者和日常生活领域中的人们，增加医疗保健带来的益处。” 在这一理念（也称为人类健康护理(hhc)理念）下，我们的目标是有效地实现社会公益，形式为缓解对健康的焦虑和减少健康差异。

With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology..

通过全球范围内的研发设施、制造基地和营销子公司网络，我们致力于创造并提供创新产品，以针对具有高度未满足医疗需求的疾病，特别是在我们的战略领域——神经学和肿瘤学——上。

In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.

此外，我们通过与全球合作伙伴共同开展各种活动，展示了我们对消除被忽视的热带病（NTDs）的承诺，这是联合国可持续发展目标（SDGs）中的一项指标（3.3）。

For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit www.eisai.eu and Eisai EMEA LinkedIn..

有关卫材的更多信息，请访问www.eisai.com（全球总部：卫材株式会社），并通过X、LinkedIn和Facebook与我们联系。本网站和社交媒体渠道面向英国和欧洲以外的受众。对于位于英国和欧洲的受众，请访问www.eisai.eu和卫材EMEA LinkedIn。

5. About Biogen

5. 关于百健

Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes.

成立于1978年的Biogen是一家领先的生物技术公司，致力于开创创新科学，提供新药物以改变患者生活，并为股东和我们的社区创造价值。我们深入理解人类生物学，并利用不同的模式推进首创的治疗方案或疗法，以实现卓越的治疗效果。

Our approach is to take bold risks, balanced with return on investment to deliver long-term growth..

我们的方法是大胆冒险，同时平衡投资回报，以实现长期增长。

The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.

公司经常在其网站 www.biogen.com 上发布可能对投资者重要的信息。关注 Biogen 的社交媒体 – Facebook、LinkedIn、X、YouTube。

Biogen Safe Harbor

百健安全港声明

This news release contains forward-looking statements, including about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab (marketed as 乐意保 in China); potential regulatory discussions, submissions and approvals and the timing thereof; the causes and treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization.

本新闻稿包含前瞻性陈述，包括关于lecanemab潜在临床效果的陈述；lecanemab（在中国市场名为乐意保）的潜在益处、安全性和有效性；潜在的监管讨论、提交和批准及其时间安排；阿尔茨海默病的成因与治疗；Biogen与Eisai合作安排的预期益处与潜力；Biogen商业业务和管线项目（包括lecanemab）的潜力；以及与药物开发和商业化相关的风险和不确定性。

These statements may be identified by words such as 'aim,' 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'forecast,' 'intend,' 'may,' 'plan,' 'possible,' 'potential,' 'will,' 'would' and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product.

这些声明可能通过诸如“目标”、“预期”、“相信”、“可能”、“估计”、“预计”、“预测”、“打算”、“或许”、“计划”、“可能”、“潜在”、“将”、“会”等词语以及其他类似含义的词语和术语来识别。药物开发和商业化涉及高度风险，仅有少数研发项目能够实现产品的商业化。

Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements..

早期临床研究中的结果可能并不代表最终结果，或后期阶段或更大规模临床研究的结果，也不能确保获得监管批准。您不应过分依赖这些声明。鉴于其前瞻性，这些声明涉及重大风险和不确定性，可能基于不准确的假设，并可能导致实际结果与声明中反映的结果存在重大差异。

These forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to differ materially from those stated or implied in this document, including, among others, uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intel.

这些前瞻性陈述基于管理层当前的信念和假设，以及管理层目前可获得的信息。鉴于其性质，我们无法保证这些前瞻性陈述中表达的任何结果将全部或部分实现。我们提醒，这些陈述受风险和不确定性的影响，其中许多是我们无法控制的，可能导致未来事件或结果与本文件中所述或暗示的内容存在重大差异，包括但不限于：我们在开发、授权或许可其他候选产品或为现有产品增加适应症方面的长期成功的不确定性；与产品批准、现有产品的额外适应症批准、销售、定价、增长、报销及已上市和研发管线产品的上市相关预期、计划、前景和行动时间表；生物制药和医疗保健行业以及其他我们参与竞争的市场中产品竞争加剧的潜在影响，包括来自新的原创疗法、仿制药、前药和现有产品的生物类似药以及通过简化监管途径获批的产品的竞争加剧；我们有效实施公司战略的能力；为我们产品获取并维持充分覆盖范围、定价和报销的困难；推动我们业务增长的因素，包括我们对合作伙伴及其他第三方在产品开发、监管审批、商业化以及其他业务方面（这些均不在我们完全掌控范围内）的依赖；与生物类似药商业化相关的风险，这取决于我们对第三方的依赖等。

These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected.

这些声明仅截至本新闻稿发布之日，并基于我们目前可获得的信息和估计。如果已知或未知的风险或不确定性成为现实，或者基本假设被证明不准确，实际结果可能与过去的结果以及预期、估计或预测的结果存在重大差异。

Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise..

投资者应注意不要过分依赖前瞻性陈述。更多风险、不确定性和其他事项的列表和描述，请参见我们截至2024年12月31日的财政年度的10-K表格年度报告以及我们随后的10-Q表格报告。除非法律要求，我们不承担任何因新信息、未来事件、情况变化或其他原因而公开更新任何前瞻性陈述的义务。

Digital Media Disclosure

数字媒体披露

From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD).

不时地，我们已经使用过，或预计将来会使用我们的投资者关系网站 (investors.biogen.com)、Biogen 的 LinkedIn 账户 (linkedin.com/company/biogen-) 和 Biogen 的 X 账户 (https://x.com/biogen)，以广泛且非排他性的方式向公众披露信息，包括用于美国证券交易委员会的公平披露规定（Reg FD）的目的。

Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors..

因此，投资者应关注我们的投资者关系网站和这些社交媒体渠道，以及我们的新闻稿、SEC文件、公开电话会议和网站，因为发布在这些平台上的信息可能对投资者至关重要。

References

参考文献

Source: globenewswire.com

来源：globenewswire.com