STOCKHOLM, Jan. 9, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that Leqembi® (brand name in China: '乐意保', generic name: lecanemab-irmb) has been approved in China as a treatment for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia.

斯德哥尔摩，2024年1月9日/PRNewswire/--BioArctic AB（publ）（纳斯达克-斯德哥尔摩：BIOA B）合作伙伴Eisai今天宣布Leqembi®（中国品牌名称：'乐意保', 通用名称：lecanemab irmb）已在中国被批准用于治疗阿尔茨海默病（AD）和轻度AD痴呆引起的轻度认知障碍（MCI）。

China is the third country to grant marketing approval, following the traditional approval in the United States in July 2023 and Japanese approval in September 2023. Eisai's preparations for the Chinese launch in the of the third quarter 2024 are underway..

中国是继2023年7月美国传统批准和2023年9月日本批准之后，第三个批准上市的国家。卫材正在为2024年第三季度在中国的发射做准备。。

Amyloid-beta (Aβ) is a protein that forms and breaks down naturally in the brain. In Alzheimer's disease, there is an imbalance between the production and elimination of Aβ, which then causes the protein to aggregate, first in smaller, soluble forms, oligomers and protofibrils, and eventually insoluble fibrils and plaques.

β淀粉样蛋白（Aβ）是一种在大脑中自然形成和分解的蛋白质。在阿尔茨海默氏病中，Aβ的产生和消除之间存在不平衡，然后导致蛋白质聚集，首先以较小的可溶性形式，低聚物和原纤维聚集，最后以不溶性原纤维和斑块聚集。

These aggregates interfere with normal brain functions and cause gradual loss of nerve cells and memory. Leqembi selectively binds to soluble (protofibrils), as well as insoluble Aβ aggregates (fibrils), thereby reducing both Aβ protofibrils and Aβ plaques in the brain. Leqembi is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism..

这些聚集体干扰正常的大脑功能，并导致神经细胞和记忆的逐渐丧失。Leqembi选择性结合可溶性（原纤维）以及不溶性Aβ聚集体（原纤维），从而减少大脑中的Aβ原纤维和Aβ斑块。Leqembi是第一个也是唯一被批准的治疗方法，通过这种机制可以降低疾病进展速度，减缓认知和功能下降。。

Leqembi's approval in China is based on the large global Phase 3 Clarity AD study. In the Clarity AD study, Leqembi met its primary endpoint and all key secondary endpoints with statistically significant results. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal..

Leqembi在中国的批准是基于大型的全球第三阶段Clarity广告研究。在Clarity AD研究中，Leqembi达到了其主要终点和所有关键次要终点，结果具有统计学意义。2022年11月，Clarity AD研究的结果发表在2022年阿尔茨海默病临床试验（CTAD）会议上，同时发表在同行评审的医学期刊《新英格兰医学杂志》上。。

Eisai estimates that there are 17 million patients with MCI or mild dementia due to AD in China today, which is expected to increase with the aging of the population. Eisai will distribute the product in China and will conduct information provision activities through specialized Medical Representatives.

卫材估计，目前中国有1700万患有MCI或轻度痴呆的AD患者，预计会随着人口老龄化而增加。卫材将在中国销售该产品，并通过专业医疗代表开展信息提供活动。

Moving forward, Eisai will focus on AD awareness via omnichannel systems and collaborate with specialists to improve the diagnostic environment, including blood-based biomarkers. In addition, by utilizing online health platform for the elderly 'Yin Fa Tong'[1], which is already being accessed by a certain number of users and helping provide treatments, Eisai is providing a one-stop service that promotes early consultation by referring patients to medical specialists and follow-up after treatment.

展望未来，卫材将通过全渠道系统专注于广告意识，并与专家合作改善诊断环境，包括基于血液的生物标志物。此外，卫材利用老年人在线健康平台“银发通”（1），该平台已经被一定数量的用户访问并帮助提供治疗，提供一站式服务，通过将患者转介给医学专家并在治疗后进行随访，促进早期咨询。

Eisai will work to improve access environments including the development of insurance programs for AD in collaboration with insurance companies. Through these efforts, Eisai will accelerate the construction of a simple patient journey in China..

卫材将努力改善接入环境，包括与保险公司合作开发AD保险计划。通过这些努力，卫材将加快在中国建设一个简单的耐心之旅。。

BioArctic has a long-term collaboration with Eisai regarding the development and commercialization for Leqembi. Eisai is responsible for the clinical development, applications for market approval and commercialization of the drug. BioArctic has no development costs for Leqembi in Alzheimer's disease and is entitled to payments in connection with certain regulatory approvals, and sales milestones as well as royalties on global sales.

BioArctic与卫材就Leqembi的开发和商业化进行了长期合作。卫材负责该药物的临床开发、市场批准申请和商业化。BioArctic对阿尔茨海默病的Leqembi没有开发成本，有权获得与某些监管批准、销售里程碑以及全球销售版税有关的付款。

In addition, BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region..

此外，BioArctic有权在欧洲批准之前在北欧地区将lecanemab商业化，目前卫材和BioArctic正在准备在该地区联合商业化。。

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 persons below, on January 9, 2024, at 09.30 a.m. CET.

该信息是BioArctic AB（publ）根据欧盟市场滥用法规有义务披露的信息。该信息于2024年1月9日上午9:30通过以下联系人机构发布，以供公开披露。

For further information, please contact: Oskar Bosson, VP Communications and IRE-mail:  [email protected]Phone: +46 70 410 71 80 Jiang Millington, Director Corporate Communication and Social Media E-mail: [email protected]Phone: +46 79 33 99 166'乐意保®' (LEQEMBI®) Product OutlineChinese Trade name: '乐意保' (LEQEMBI)Chinese generic name: 仑卡奈单抗注射液 (lecanemab injection)Indication for use: Treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia Dosage and administration: The usual dose of lecanemab (recombinant) is 10mg/kg infused intravenously over approximately 1 hour, once every 2 weeks.Active ingredients and strength: 200mg (2mL)/1 vial and 500mg (5mL)/1 vial.

欲了解更多信息，请联系：通信和IRE副总裁Oskar Bosson邮箱：[受电子邮件保护]电话：+46 70 410 71 80 Jiang Millington，企业通信和社交媒体总监电子邮件：[受电子邮件保护]电话：+46 79 33 99 166'乐意保®'（LEQEMBI®）产品大纲中文商品名：'乐意保' （LEQEMBI）中文通用名：仑卡奈单抗注射液（莱卡单抗注射液）使用指征：治疗阿尔茨海默病（AD）和轻度AD痴呆引起的轻度认知障碍（MCI）剂量和给药：莱卡单抗（重组）的常规剂量为10mg/kg，静脉注射约1小时，每2周一次。活性成分和强度：200mg（2mL）/1瓶和500mg（5mL）/1瓶。

About Leqembi® (lecanemab) Leqembi (lecanemab) is the result of a strategic research alliance between BioArctic and Eisai. Leqembi is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Leqembi is an amyloid beta-directed antibody indicated as a disease-modifying treatment for Alzheimer's disease (AD) in the US.

关于Leqembi®（lecanemab）Leqembi（lecanemab）是BioArctic和Eisai之间战略研究联盟的结果。Leqembi是一种人源化免疫球蛋白γ1（IgG1）单克隆抗体，针对聚集的可溶性（原纤维）和不溶性淀粉样β（aβ）形式。Leqembi是一种淀粉样β定向抗体，在美国被认为是阿尔茨海默氏病（AD）的疾病缓解疗法。

Leqembi was granted traditional approval by the US Food and Drug Administration (FDA) on July 6, 2023. Treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied..

2023年7月6日，Leqembi获得美国食品和药物管理局（FDA）的传统批准。Leqembi治疗应在轻度认知障碍或轻度痴呆疾病阶段的患者中开始，这些患者是在临床试验中开始治疗的人群。与研究相比，在疾病的早期或晚期开始治疗没有安全性或有效性数据。。

Please see full U.S. Prescribing Information, including Boxed WARNING.

请参阅完整的美国处方信息，包括盒装警告。

In Japan, Eisai received approval from the Ministry of Health, Labour and Welfare (MHLW) on September 25, 2023, to manufacture and market lecanemab as a treatment for slowing progression of MCI and mild dementia due to AD.

在日本，卫材于2023年9月25日获得厚生劳动省（MHLW）的批准，生产和销售lecanemab，作为减缓MCI进展和AD引起的轻度痴呆的治疗方法。

Eisai has also submitted applications for approval of lecanemab in 11 countries and regions, including EU, Canada and Great Britain.

卫材还向包括欧盟、加拿大和英国在内的11个国家和地区提交了lecanemab的批准申请。

Eisai has completed a lecanemab subcutaneous bioavailability study, and subcutaneous dosing is currently being evaluated in the Clarity AD (Study 301) open-label extension (OLE) study. A maintenance dosing regimen has been evaluated as part of the Phase 2b study (Study 201).

卫材已经完成了一项莱卡单抗皮下生物利用度研究，目前正在Clarity AD（研究301）开放标签延伸（OLE）研究中评估皮下给药。作为2b期研究（研究201）的一部分，已经评估了维持给药方案。

Since July 2020 Eisai's 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 and Eisai..

自2020年7月以来，卫材针对临床前AD患者的3期临床研究（AHEAD 3-45）正在进行中，这意味着他们在临床上是正常的，大脑中的淀粉样蛋白水平处于中等或升高水平。AHEAD 3-45是阿尔茨海默氏病临床试验联盟（Alzheimer's Clinical Trial Consortium）之间的公私合作伙伴关系，该联盟为美国AD和相关痴呆症的学术临床试验提供基础设施，由国家老龄研究所（National Institute on Aging）资助，该研究所是国立卫生研究院（National Institutes of Health）和卫材（Eisai）的一部分。。

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，由圣路易斯华盛顿大学医学院领导的显性遗传性阿尔茨海默病网络试验单位（DIAN-TU）进行的显性遗传性AD（DIAD）的Tau-NexGen临床研究正在进行中，其中包括lecanemab作为抗淀粉样蛋白治疗的骨干。。

About the collaboration between BioArctic and EisaiSince 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.

关于BioArctic和EisaiSince 2005之间的合作，BioArctic与Eisai就治疗阿尔茨海默病的药物的开发和商业化进行了长期合作。最重要的协议是2007年签署的lecanemab抗体开发和商业化协议，以及2015年签署的阿尔茨海默病抗体Leqembi备份的开发和商业化协议。

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 under certain conditions and is currently preparing for commercialization in the Nordics together with Eisai.

2014年，卫材和Biogen签订了lecanemab的联合开发和商业化协议。卫材负责阿尔茨海默病产品的临床开发、市场批准申请和商业化。BioArctic有权在某些条件下在北欧地区将lecanemab商业化，目前正在与卫材一起准备在北欧商业化。

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对阿尔茨海默氏病中的lecanemab没有开发成本，并且有权获得与监管批准，销售里程碑以及全球销售版税有关的付款。。

About BioArctic ABBioArctic AB (publ) is a Swedish research-based biopharma company focusing on 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.

ABBioArctic Abbioarcic AB（publ）是一家瑞典研究性生物制药公司，专注于延缓或阻止神经退行性疾病进展的治疗。该公司发明了Leqembi®（lecanemab），这是世界上第一种被证明可以减缓疾病进展并减少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与BioArctic的合作伙伴Eisai共同开发，Eisai负责全球监管互动和商业化。除Leqembi外，BioArctic还拥有广泛的研究组合，包括针对帕金森氏病和ALS的抗体以及针对阿尔茨海默氏病的其他项目。

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 www.bioarctic.se..

其中一些项目利用了该公司专有的BrainTransporter™ 这项技术有可能主动将抗体转运穿过血脑屏障，以提高治疗效果。BioArctic的B股（BIOA B）在纳斯达克斯德哥尔摩大盘股上市。有关更多信息，请访问www.bioarctic.se。。

[1] An online business (Chinese name:銀髪通) of Jingyi Weixiang (Shanghai) Health Industry Development Limited Company, a joint venture company with JD Health.

[1] 在线企业（中文名称：銀髪通) 与JD Health合资成立的经一伟翔（上海）健康产业发展有限公司。

The following files are available for download:

以下文件可供下载：

https://mb.cision.com/Main/9978/3905921/2528504.pdf

https://mb.cision.com/Main/9978/3905921/2528504.pdf

Leqembi® approved for the treatment of Alzheimer’s disease in China

Leqembi®被批准用于治疗阿尔茨海默病™s病在中国