美国食品药品监督管理局（FDA）批准了Leqembi® IQKLIK™（lecanemab-irmb）皮下注射剂，用于治疗早期阿尔茨海默病的维持剂量-动脉网

US FDA approves Leqembi® IQKLIK ™ (lecanemab-irmb) subcutaneous injection for maintenance dosing for the treatment of early Alzheimer's disease

CISION 等信源发布 2025-08-30 06:11



可切换为仅中文







STOCKHOLM

斯德哥尔摩

，

Aug. 29, 2025

2025年8月29日

/PRNewswire/ --

/美通社/ --

BioArctic AB's (publ)

BioArctic AB（公众公司）

(Nasdaq Stockholm: BIOA-B)

（纳斯达克斯德哥尔摩：BIOA-B）

partner Eisai announced today the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for once weekly lecanemab subcutaneous injection for maintenance dosing. LEQEMBI IQLIK autoinjector is indicated for maintenance dosing to treat Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, collectively referred to as early AD, in the U.S.

合作伙伴卫材今天宣布，美国食品药品监督管理局 (FDA) 已批准每周一次 lecanemab 皮下注射剂的生物制品许可申请 (BLA)，用于维持剂量。LEQEMBI IQLIK 自动注射器在美国被指定用于治疗早期阿尔茨海默病 (AD)，包括轻度认知障碍 (MCI) 或轻度痴呆阶段的患者，统称为早期 AD。

LEQEMBI IQLIK will be launched on .

LEQEMBI IQLIK 将于发布。

October 6, 2025

2025年10月6日

。

The U.S. brand name for the subcutaneous autoinjector is LEQEMBI IQLIK (pronounced 'I Click'). After 18 months of Leqembi intravenous (IV) treatment at 10 mg/kg every two weeks, patients may either continue IV infusions at 10 mg/kg once every four weeks or the new weekly 360 mg subcutaneous injection using the LEQEMBI IQLIK autoinjector..

美国皮下自动注射器的品牌名称为LEQEMBI IQLIK（发音为“I Click”）。在完成18个月的Leqembi静脉（IV）治疗，剂量为每两周10 mg/kg后，患者可以选择继续每四周一次10 mg/kg的静脉输注，或者使用LEQEMBI IQLIK自动注射器进行每周一次360 mg的皮下注射。

Alzheimer's disease is a progressive, relentless disease with Aβ and tau as hallmarks. It progresses in stages that increase in severity over time, and each stage of the disease presents different challenges for those living with the disease and their care partners. There is a significant unmet need for new treatment options that slow the progression of Alzheimer's disease from its early stage and reduce the overall burden on people affected by Alzheimer's disease and society.

阿尔茨海默病是一种以Aβ和tau为特征的渐进性、无情发展的疾病。它分阶段发展，严重程度随时间增加，疾病的每个阶段都给患者及其护理伙伴带来不同的挑战。目前迫切需要新的治疗方案来减缓阿尔茨海默病从早期开始的进展，并减轻该疾病对患者和社会造成的整体负担。

Only Leqembi fights Alzheimer's disease (AD) in two ways - targeting both amyloid plaque and protofibrils.

仅Leqembi以两种方式对抗阿尔茨海默病（AD）——靶向淀粉样蛋白斑块和原纤维。

[1]

, which can impact tau accumulation downstream.

，这可能影响下游的tau积累。

[2]

,[3]

Due to the re-accumulation of AD biomarkers and a return to a placebo rate of decline after therapy is stopped, maintenance treatment offers patients options to slow the disease progression and prolong the benefit of therapy, with the goal of helping patients maintain who they are for longer.

由于AD生物标志物的再次积累，以及停止治疗后衰退速度恢复到安慰剂水平，维持治疗为患者提供了延缓疾病进展和延长治疗益处的选择，旨在帮助患者更长时间地保持自我状态。

'Eisai's continued work to support and simplify patient and healthcare administration and treatment is an important work to help remove potential bottlenecks in healthcare and broaden patient population while supporting a sustainable long-term cost of treatment,' says

“卫材持续开展工作以支持和简化患者及医疗管理与治疗，这对于帮助消除医疗瓶颈、扩大患者群体以及在支持长期可持续的治疗成本方面具有重要意义，”

Gunilla Osswald

吉尼拉·奥斯瓦尔德

, CEO at BioArctic.

，BioArctic首席执行官。

From the perspective of patients and care partners, this can provide the ability to use the device at home, a shortening of treatment time and continued treatment without having to visit an infusion centre. The subcutaneous formulation also has the potential to reduce healthcare resources associated with IV maintenance dosing, such as preparation for infusion and nurse monitoring, while increasing infusion capacity for new eligible patients to begin initiation treatment and streamlining the overall AD treatment pathway..

从患者和护理伙伴的角度来看，这可以提供在家中使用设备的能力，缩短治疗时间，并且无需前往输液中心即可继续治疗。皮下注射制剂还有可能减少与静脉注射维持剂量相关的医疗资源，例如输液准备和护士监控，同时增加新符合条件的患者开始初始治疗的输液能力，并简化整体阿尔茨海默病治疗路径。

Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor

Leqembi 是 BioArctic 与卫材长期合作的成果，该抗体最初由 BioArctic 基于教授的工作开发。

Lars Lannfelt

拉尔斯·兰费尔特

and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Leqembi for Alzheimer's disease. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai and the two companies are preparing for a joint commercialization in the region..

他发现了阿尔茨海默病中的北极突变。卫材负责Leqembi在阿尔茨海默病领域的临床开发、上市申请及商业化。BioArctic与卫材共同拥有在北欧地区将Leqembi商业化的权利，两家公司正准备在该地区进行联合推广。

This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person below, on

此信息是 BioArctic AB（公众公司）根据欧盟市场滥用监管规定必须披露的信息。该信息通过以下联系人向公众发布于

August 29, 2025

2025年8月29日

, at

，位于

11:55 p.m. CET

晚上11点55分（中欧时间）

。

For further information, please contact:

如需更多信息，请联系：

Oskar Bosson

奥斯卡·博森

, Vice President Communications and Investor Relations

，副总裁，通信与投资者关系

E-mail

电子邮件

：

oskar.bosson@bioarctic.com

Telephone: +46 70 410 71 80

电话：+46 70 410 71 80

About lecanemab (Leqembi

关于lecanemab（Leqembi）

)

Lecanemab is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).

Lecanemab 是 BioArctic 与 Eisai 战略研究联盟的成果。它是一种人源化的免疫球蛋白伽马 1（IgG1）单克隆抗体，靶向针对β淀粉样蛋白（Aβ）的聚集可溶性（原纤维）和不可溶形式。

Lecanemab is approved in 48 countries including the U.S.,

勒卡内单抗已获包括美国在内的48个国家批准，

Japan

日本

，

China

中国

, and the European Union for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD), and is under regulatory review in 10 countries

，以及欧洲联盟用于治疗轻度认知障碍（MCI）或轻度痴呆阶段的阿尔茨海默病（AD）患者（统称为早期AD），并且正在10个国家接受监管审查。

Since

自以来

July 2020

2020年7月

, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical Alzheimer's disease, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in

，卫材在患有临床前阿尔茨海默病（意味着他们临床表现正常且大脑中具有中等或升高水平的淀粉样蛋白）的个体中进行的lecanemab三期临床研究（AHEAD 3-45）正在进行中。该研究已经完成全部招募。

October 2024

2024年10月

. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in Alzheimer's disease and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health.

AHEAD 3-45 是一项为期四年的研究，由卫材、渤健和阿尔茨海默病临床试验联盟以公私合作的方式开展。该联盟为美国境内针对阿尔茨海默病及相关痴呆的学术临床试验提供基础设施，由国立卫生研究院下属的国家老龄化研究所资助。

Since .

自从。

January 2022

2022年1月

, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by

，由显性遗传阿尔茨海默病网络试验组（DIAN-TU）主导的显性遗传阿尔茨海默病（DIAD）Tau NexGen临床研究，

Washington University

华盛顿大学

School of Medicine in

医学院在

St. Louis

圣路易斯

, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

，正在进行中，并包括lecanemab作为基础抗淀粉样蛋白疗法。

About the collaboration between BioArctic and Eisai

关于BioArctic与Eisai的合作

Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization Agreement for the lecanemab antibody, which was signed 2007, and the Development and Commercialization agreement for the antibody Leqembi back-up for Alzheimer's disease, which was signed 2015.

自2005年以来，BioArctic与卫材就在阿尔茨海默病治疗药物的开发和商业化方面有着长期的合作。其中最重要的协议包括：2007年签署的lecanemab抗体《开发与商业化协议》，以及2015年签署的阿尔茨海默病备用抗体Leqembi的《开发与商业化协议》。

In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region and is currently preparing for commercialization in the Nordics together with Eisai.

2014年，卫材和渤健就lecanemab签订了共同开发和商业化协议。卫材负责阿尔茨海默病产品的临床开发、上市申请和商业化。BioArctic拥有在北欧地区将lecanemab商业化的权利，目前正与卫材一起准备在北欧的商业化工作。

BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with regulatory approvals, and sales milestones as well as royalties on global sales..

BioArctic在阿尔茨海默病的lecanemab上没有开发成本，并有权获得与监管批准、销售里程碑相关的付款，以及全球销售额的特许权使用费。

About BioArctic AB

关于BioArctic AB

BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease.

BioArctic AB（publ）是一家瑞典研究型生物制药公司，专注于开发能够延缓或阻止神经退行性疾病进展的创新疗法。该公司发明了Leqembi®（lecanemab）——全球首款被证明可以减缓疾病进展并减轻早期阿尔茨海默病认知障碍的药物。

Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease.

Leqembi 由 BioArctic 的合作伙伴 Eisai 共同开发，Eisai 负责全球的监管互动和商业化。除了 Leqembi，BioArctic 还拥有针对帕金森病和肌萎缩侧索硬化症（ALS）的抗体以及更多针对阿尔茨海默病的广泛研究项目。

Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit .

其中几个项目利用了公司的专有技术BrainTransporter™，这项技术有可能主动将抗体转运穿过血脑屏障，从而提高治疗效果。BioArctic的B股（BIOA B）在纳斯达克斯德哥尔摩大型股票上市。欲了解更多信息，请访问。

www.bioarctic.com

。

[1]

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.

原纤维被认为是导致AD脑损伤的原因之一，并被认为是Aβ最具毒性形式，在这种渐进性、衰弱性疾病的认知能力下降中起主要作用。

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.

原纤维会导致大脑中的神经元受损，这反过来又会通过多种机制对认知功能产生负面影响，不仅会增加不溶性Aβ斑块的形成，还会增加对脑细胞膜以及在神经细胞之间或神经细胞与其他细胞之间传递信号的连接的直接损伤。

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

人们认为，减少原纤维的形成可能通过减少大脑神经元损伤和认知功能障碍来防止阿尔茨海默病的进展。

二

[2]

Eisai presents long-term administration data of lecanemab at the Alzheimer's Association International Conference (AAIC) 2024. Available at:

卫材在2024年阿尔茨海默病协会国际会议（AAIC）上展示了lecanemab的长期管理数据。来源：

https://www.eisai.co.jp/ir/library/presentations/pdf/4523_240731_1.pdf

[3]

McDade et al. Lecanemab in patients with early Alzheimer's disease: detailed results on biomarker, cognitive, and clinical effects from the randomized and open-label extension of the phase 2 proof-of-concept study. Alzheimers Res Ther. 2022 Dec 21;14(1):191. doi: 10.1186/s13195-022-01124-2.

麦克达德等。Lecanemab在早期阿尔茨海默病患者中的应用：来自2期概念验证研究的随机和开放标签扩展的生物标志物、认知和临床效果的详细结果。《阿尔茨海默病研究与治疗》。2022年12月21日；14(1):191。doi: 10.1186/s13195-022-01124-2。

i Morris JC. Neurology. 1993;43(11):2412-4.

Morris JC。神经病学。1993年；43（11）：2412-4。

ii Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.

ii 小野K，辻M。β淀粉样蛋白的原纤维是阿尔茨海默病修饰治疗的重要靶点。《国际分子科学杂志》。2020；21（3）：952。doi: 10.3390/ijms21030952。PMID: 32023927；PMCID: PMC7037706。

This information was brought to you by Cision

此信息由Cision提供给您

http://news.cision.com

https://news.cision.com/bioarctic/r/us-fda-approves-leqembi--iqklik----lecanemab-irmb--subcutaneous-injection-for-maintenance-dosing-for,c4226923

https://news.cision.com/bioarctic/r/美国食品药品监督管理局批准Leqembi–Iqklik（lecanemab-irmb）皮下注射用于维持剂量治疗,c4226923

The following files are available for download:

以下文件可供下载：

https://mb.cision.com/Main/9978/4226923/3637810.pdf

US FDA approves Leqembi® IQKLIK(TM) (lecanemab-irmb) subcutaneous injection for maintenance dosing for the treatment of early Alzheimer's disease

美国FDA批准Leqembi® IQKLIK(TM)（lecanemab-irmb）皮下注射用于治疗早期阿尔茨海默病的维持剂量

SOURCE BioArctic