LEQEMBI IQLIK is the first and only anti-amyloid treatment to offer an at-home injection to help patients and care partners continue to treat this progressive, relentless disease

LEQEMBI IQLIK 是首个也是唯一一个提供在家注射的抗淀粉样蛋白治疗方案，帮助患者和护理伙伴继续治疗这种进展性、无情的疾病。

after initial treatment of 18 months

初步治疗18个月后

LEQEMBI IQLIK will be launched on

LEQEMBI IQLIK 将于

October 6th, 2025

2025年10月6日

, in the U.S.

，在美国

TOKYO

东京

and

和

CAMBRIDGE, Mass.

马萨诸塞州剑桥市

,

，

Aug. 29, 2025

2025年8月29日

/PRNewswire/ -- Eisai Co., Ltd. (Headquarters:

/PRNewswire/ -- 卫材株式会社（总部：

Tokyo

东京

, CEO:

，首席执行官：

Haruo Naito

奈良久男

, 'Eisai')  and Biogen Inc. (Nasdaq:

，‘卫材’）和百健公司（纳斯达克：

BIIB

百健

, Headquarters:

，总部：

Cambridge, Massachusetts

马萨诸塞州剑桥市

, CEO:

，首席执行官：

Christopher A. Viehbacher

克里斯托弗·A·维赫巴赫

, 'Biogen') announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for once weekly lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI

，'Biogen'）今天宣布，美国食品药品监督管理局（FDA）已批准每周一次 lecanemab-irmb 皮下注射的生物制品许可申请（BLA）（美国品牌名称：LEQEMBI）。

®

®

IQLIK

IQLIK

TM

商标

, pronounced 'I Click') for maintenance dosing. LEQEMBI IQLIK is a subcutaneous autoinjector (SC-AI) developed by Eisai, containing 360 mg/1.8 mL (200 mg/mL) that can be administered in approximately 15 seconds. 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.

，发音为‘I Click’）用于维持剂量。LEQEMBI IQLIK 是由卫材开发的一种皮下自动注射器（SC-AI），含有360毫克/1.8毫升（200毫克/毫升），大约15秒内即可完成注射。LEQEMBI IQLIK 自动注射器在美国适用于治疗轻度认知障碍（MCI）或疾病轻微痴呆阶段（统称为早期阿尔茨海默病（AD））患者的维持剂量。

After 18 months of LEQEMBI (lecanemab-irmb) 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 start the new weekly 360 mg subcutaneous injection using the LEQEMBI IQLIK autoinjector..

在每两周一次、每次每公斤体重10毫克的LEQEMBI（lecanemab-irmb）静脉注射治疗18个月后，患者可以选择继续每四周一次、每次每公斤体重10毫克的静脉注射，或者开始使用LEQEMBI IQLIK自动注射器进行每周一次360毫克的皮下注射。

Clinical Trials Supporting Subcutaneous Maintenance Dosing Approval

支持皮下维持剂量批准的临床试验

The BLA is based on LEQEMBI subcutaneous (SC) sub-studies of the Phase 3 Clarity AD open-label extension (OLE) trial in individuals with early AD, which evaluated a range of subcutaneous doses. Data shows that transitioning to the weekly LEQEMBI IQLIK autoinjector after 18 months of the initiation dose (10 mg/kg IV every two weeks) maintains clinical and biomarker benefits comparable to continued IV dosing..

基于早期阿尔茨海默病（AD）患者的三期Clarity AD开放标签延长期（OLE）试验中LEQEMBI皮下注射（SC）子研究，BLA评估了一系列皮下注射剂量。数据显示，在初始剂量（每两周10 mg/kg静脉注射）18个月后，转为每周使用LEQEMBI IQLIK自动注射器，其临床和生物标志物的益处与持续静脉注射相当。

The safety of LEQEMBI IQLIK autoinjector was studied in over 600 patients at a range of doses as part of the Clarity AD OLE.

在Clarity AD OLE研究中，对600多名患者使用不同剂量的LEQEMBI IQLIK自动注射器的安全性进行了研究。

49 patients received a weekly 360 mg subcutaneous maintenance dose after at least 18 months of 10 mg/kg IV every two weeks. Importantly, none of these patients experienced any local or systemic injection-related adverse events (AEs).

49 名患者在至少 18 个月的每两周一次 10 mg/kg 静脉注射后，接受了每周 360 mg 的皮下维持剂量。重要的是，这些患者均未出现任何局部或系统性注射相关不良事件 (AE)。

Across all subcutaneous doses, the safety profile was similar to that of the IV maintenance treatment with one key difference: systemic reactions were much less common with subcutaneous dosing—less than 1% compared to approximately 26% with IV infusions. Approximately 11% of patients experienced mild-to-moderate local reactions (such as redness, swelling or itching at the injection site), which did not interfere with continued administration, and less than 1% had mild systemic symptoms such as headache, fever or fatigue..

在所有皮下注射剂量中，安全特性与静脉维持治疗相似，但有一个关键区别：皮下注射的全身反应要少得多——不到1%，而静脉输注则约为26%。大约11%的患者出现了轻到中度的局部反应（如注射部位发红、肿胀或瘙痒），但并未影响继续用药；不到1%的患者出现了轻微的全身症状，如头痛、发热或疲劳。

ARIA rates in patients who received a weekly 360 mg subcutaneous maintenance dose were similar to ARIA rates reported in patients who continued with the IV dose after 18 months and are similar to the background rates of ARIA in patients without treatment. ARIA is usually asymptomatic, although serious and life-threatening events can occur.

接受每周360毫克皮下维持剂量的患者中出现的ARIA发生率与继续使用静脉注射剂量18个月后的患者报告的ARIA发生率相似，并且与未接受治疗的患者中ARIA的背景发生率相似。ARIA通常是无症状的，尽管可能会发生严重和危及生命的事件。

ARIA can be fatal. Most ARIA with LEQEMBI occurs within the first 6 months of IV initiation treatment..

ARIA 可能是致命的。使用 LEQEMBI 时，大多数 ARIA 发生在静脉注射治疗开始后的前 6 个月内。

Importance of Ongoing Treatment

持续治疗的重要性

AD is a progressive, relentless disease with amyloid beta (Aβ) and tau as hallmarks, caused by a continuous underlying neurotoxic process that begins before amyloid plaque removal and continues afterward.

AD是一种由持续的潜在神经毒性过程引起的渐进性、无情的疾病，其特征是β淀粉样蛋白（Aβ）和tau，该过程在淀粉样斑块清除之前开始，并在此之后继续。

1,2,3

1,2,3

Only LEQEMBI fights AD in two ways – targeting both amyloid plaque and protofibrils*, which can impact tau downstream. Due to the reaccumulation of AD biomarkers and return to placebo rate of decline after therapy is stopped,

只有LEQEMBI能够以两种方式对抗阿尔茨海默病（AD）——同时靶向淀粉样蛋白斑块和原纤维*，这可能对下游的tau蛋白产生影响。由于停止治疗后阿尔茨海默病生物标志物的重新积累以及下降速度恢复至安慰剂水平，

4, 5

4, 5

maintenance treatment with once-weekly SC injection or once every four weeks of IV therapy offers patients options to continue slowing the disease progression and prolong the benefit of therapy, with the goal of helping patients maintain who they are for longer.

每周一次皮下注射或每四周一次静脉注射的维持治疗为患者提供了继续减缓疾病进展和延长治疗效益的选择，其目标是帮助患者更长时间地保持自我状态。

In the Clarity AD core study, the mean change from baseline between the lecanemab IV once every 2 weeks treated group and the placebo group after 18 months was -0.45 (P=0.00005) on the primary endpoint of CDR-SB global cognitive and functional scale.

在Clarity AD核心研究中，每两周一次静脉注射lecanemab治疗组与安慰剂组在18个月后，主要终点CDR-SB整体认知和功能量表上相对于基线的平均变化为-0.45（P=0.00005）。

To provide context, a change from 0.5 to 1 on the Clinical Dementia Rating (CDR) score domains of Memory, Community Affairs and Home/Hobbies reflects a shift from mild impairment to loss of independence. This can affect a person's ability to be left alone safely, recall recent events, participate in daily activities, manage household tasks, and engage in hobbies and intellectual interests..

为了提供背景，临床痴呆评定量表（CDR）中记忆、社区事务和家庭/爱好领域的评分从0.5变为1，反映了从轻度受损到丧失独立性的转变。这可能影响一个人安全独处、回忆近期事件、参与日常活动、处理家务任务以及从事爱好和智力兴趣的能力。

6, 7

6, 7

At 48 months of treatment through the Clarity AD core study and its OLE, data showed lecanemab demonstrated a reduction in cognitive decline measured by CDR-SB of -1.75 points compared to the expected decline observed in the Alzheimer's Disease Neuroimaging Initiative (ADNI)*

在Clarity AD核心研究及其开放标签扩展（OLE）的48个月治疗期间，数据显示，与阿尔茨海默病神经影像学计划（ADNI）*中观察到的预期下降相比，lecanemab在CDR-SB测量的认知衰退上减少了1.75点。

2

2

cohort.

队列。

Similarly, when benchmarked against the expected decline in the BioFINDER*

同样，当与 BioFINDER* 中预期的下降进行基准对比时

3

3

cohort, lecanemab showed a reduction of -2.17 points measured by CDR-SB at the four-year mark.

在四年时，通过CDR-SB测量，lecanemab显示减少了2.17点。

Importance of SC Maintenance Option

SC维护选项的重要性

To confirm the safe and effective use of LEQEMBI IQLIK in the expected use environments, additional studies were conducted, including a human factors (HF) study*

为确认 LEQEMBI IQLIK 在预期使用环境中的安全有效使用，开展了额外的研究，包括人因工程 (HF) 研究*。

4

4

and a tolerability assessment of the device.

以及对设备的耐受性评估。

From the perspective of patients and care partners, benefits included the ability to use the device at home, shortening treatment time and to continue treatment without having to worry about visiting an infusion center. Healthcare providers reported that the device has the potential to provide a new option for patients who are responding well to LEQEMBI and should continue treatment.

从患者和护理伙伴的角度来看，好处包括能够在家中使用该设备、缩短治疗时间并无需担心前往输液中心继续治疗。医疗保健提供者报告称，该设备有可能为那些对LEQEMBI反应良好且应继续治疗的患者提供一种新选择。

The SC 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..

皮下注射制剂还具有减少与静脉维持剂量相关的医疗资源的潜力，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，并简化整个AD治疗途径。

Patient Support Programs

患者支持计划

Eisai is committed to ensuring that appropriate patients have access to LEQEMBI. In the U.S. Eisai offers several support programs to help patients and care partners. Dedicated Patient Navigators will work directly with patients and families to navigate treatment and coverage for eligible and appropriate patients and to help with what to expect regarding insurance coverage, co-pay and patient access programs.

卫材致力于确保合适的患者能够获得LEQEMBI。在美国，卫材提供多项支持计划，以帮助患者和护理伙伴。专职患者导航员将直接与患者及其家属合作，为符合条件的合适患者提供治疗和覆盖指导，并帮助了解保险覆盖、共付费用及患者获取计划的相关信息。

Injection support will also be available for LEQEMBI IQLIK patients. To learn more visit .

LEQEMBI IQLIK 患者也将获得注射支持。欲了解更多信息，请访问。

LEQEMBI.com

LEQEMBI.com

, call 1-833-4-LEQEMBI (1-833-453-7362), Monday-Friday,

，拨打1-833-4-LEQEMBI（1-833-453-7362），周一至周五，

8 a.m. to 8 p.m. Eastern Time

东部时间早上8点到晚上8点

.

。

In addition, to support access to LEQEMBI for certain patients who need help paying for their medicines, Eisai's Patient Assistance Program (PAP) will provide LEQEMBI and LEQEMBI IQLIK at no cost, for eligible uninsured and underinsured patients, including Medicare beneficiaries, who meet financial need and other program criteria..

此外，为了帮助某些需要药物费用支持的患者获得LEQEMBI，卫材的患者援助计划（PAP）将为符合条件的无保险和保险不足的患者（包括符合经济需求和其他项目标准的 Medicare 受益人）免费提供 LEQEMBI 和 LEQEMBI IQLIK。

LEQEMBI IQLIK will be launched on

LEQEMBI IQLIK 将于

October 6, 2025

2025年10月6日

in the U.S. Click

在美国点击

here

这里

to learn about how LEQEMBI IQLIK offers patient-centric early Alzheimer's care and our U.S. Pricing Approach.

了解LEQEMBI IQLIK如何提供以患者为中心的早期阿尔茨海默病护理以及我们的美国定价策略。

Eisai serves as the lead for lecanemab's development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

卫材在全球范围内主导lecanemab的开发和监管提交工作，卫材和渤健共同负责该产品的商业化和推广，卫材拥有最终决策权。

* Protofibrils are thought to be the most toxic Aβ species that contribute to brain damage in AD and play a major role in the cognitive decline of this progressive and devastating disease. Protofibrils can cause neuronal and synaptic damage in the brain, which can subsequently adversely affect cognitive function through multiple mechanisms..

* 原纤维被认为是导致阿尔茨海默病（AD）脑损伤的最具毒性的Aβ物种，并在这一渐进性和破坏性疾病的认知衰退中起主要作用。原纤维可导致大脑中的神经元和突触损伤，随后通过多种机制对认知功能产生不利影响。

8

8

The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aβ plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially preventing the progression of AD..

这种现象的发生机制不仅通过增加不溶性Aβ斑块的形成，还通过直接损害神经元与其他细胞之间的信号传导而被报道。人们认为，减少原纤维可能减轻神经元损伤和认知障碍，从而可能阻止AD的进展。

9

9

*

*

2

2

ADNI is a clinical research project launched in 2005 to develop methods to predict the onset and progression of AD and to confirm the effectiveness of treatments. The project involves a multi-year longitudinal observation targeting healthy elderly individuals as well as patients with mild cognitive impairment (MCI) and early stages of AD..

ADNI 是一个于 2005 年启动的临床研究项目，旨在开发预测 AD（阿尔茨海默病）发病和进展的方法，并验证治疗的有效性。该项目涉及多年纵向观察，针对健康老年人以及轻度认知障碍 (MCI) 和早期 AD 患者。

*

*

3

3

BioFINDER subjects are similar to Clarity AD and ADNI subjects, except all BioFINDER subjects are in the MCI stage and no mild AD subjects are included, and their baseline CDR-SB is lower. BioFINDER is a large-scale, long-term prospective study led by

BioFINDER受试者与Clarity AD和ADNI的受试者相似，但所有BioFINDER受试者均处于MCI阶段，且不包括轻度AD受试者，其基线CDR-SB较低。BioFINDER是一项由以下机构领导的大规模、长期前瞻性研究。

Lund

隆德

University in

大学在

Sweden

瑞典

, aiming to establish early diagnosis and elucidate pathophysiology of neurodegenerative diseases. In addition to AD, the study also focuses on conditions including Parkinson's Disease. Individuals participating in the study undergo regular clinical assessments, cognitive function tests, brain imaging (MRI, Aβ PET, Tau PET), and collection of biomarkers from blood and cerebrospinal fluid (CSF)..

，旨在建立神经退行性疾病的早期诊断并阐明其病理生理机制。除了阿尔茨海默病，研究还关注包括帕金森病在内的其他疾病。参与研究的个体需接受定期的临床评估、认知功能测试、脑成像（MRI、Aβ PET、Tau PET）以及血液和脑脊液（CSF）生物标志物的采集。

*

*

4

4

Human factors study is a practical scientific discipline that comprehensively analyzes human cognitive characteristics, physical and mental traits, as well as the environment, organizations, systems, and institutions that influence them. It aims to elucidate the mechanisms of human error occurrence and to build safe, comfortable, and efficient systems and work environments.

人的因素研究是一门实用的科学学科，综合分析人的认知特性、身心特点以及影响它们的环境、组织、系统和制度，旨在阐明人为失误的发生机制，构建安全、舒适、高效的工作系统和工作环境。

This human factors study was conducted to verify that LEQEMBI IQLIK can be used safely and effectively in the expected use environment..

这项人为因素研究旨在验证 LEQEMBI IQLIK 在预期使用环境中能够安全有效地使用。

INDICATION

适应症

LEQEMBI® is indicated for the treatment of Alzheimer's disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

LEQEMBI® 适用于治疗阿尔茨海默病 (AD)。LEQEMBI 的治疗应在患有轻度认知障碍 (MCI) 或疾病处于轻度痴呆阶段的患者中开始，这是在临床试验中开始治疗的人群。

IMPORTANT SAFETY INFORMATION

重要安全信息

WARNING: AMYLOID-RELATED IMAGING ABNORMALITIES (ARIA)

警告：与淀粉样蛋白相关的影像学异常 (ARIA)

•

•

Monoclonal antibodies directed against aggregated forms of beta amyloid, including LEQEMBI, can cause ARIA, characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. ARIA usually occurs early in treatment and is usually asymptomatic.

针对β淀粉样蛋白聚集形式的单克隆抗体，包括LEQEMBI，可能引起ARIA，表现为水肿型ARIA（ARIA-E）和含铁血黄素沉积型ARIA（ARIA-H）。不同治疗中ARIA的发生率和时间各不相同。ARIA通常在治疗早期出现，且通常无症状。

, although serious and life-threatening events, including seizure and status epilepticus, can occur. ARIA can be fatal. Serious intracerebral hemorrhages (ICH) >1 cm, some of which have been fatal, have been observed with this class of medications. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy to a patient being treated with LEQEMBI..

，虽然严重且危及生命的情况，包括癫痫发作和癫痫持续状态，可能会发生。ARIA 可能是致命的。使用这类药物已观察到严重的脑内出血 (ICH) >1 厘米，其中一些是致命的。由于 ARIA-E 可引起局灶性神经功能缺损，可能模仿缺血性中风，在给予接受 LEQEMBI 治疗的患者溶栓治疗前，应考虑这些症状是否可能是由 ARIA-E 引起的。

o

o

Apolipoprotein E ε4 (ApoE ε4) Homozygotes

载脂蛋白E ε4（ApoE ε4）纯合子

: Patients who are ApoE ε4 homozygotes (~15% of patients with AD) treated with this class of medications have a higher incidence of ARIA, including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and noncarriers. Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.

：与杂合子和非携带者相比，使用这类药物治疗的ApoE ε4纯合子患者（约占AD患者的15%）发生ARIA的几率更高，包括有症状、严重以及严重的影像学ARIA。在开始治疗前应进行ApoE ε4状态检测，以评估发生ARIA的风险。

Prior to testing, prescribers should discuss with patients the risk of ARIA across genotypes and the implications of genetic testing results. Prescribers should inform patients that if genotype testing is not performed, they can still be treated with LEQEMBI; however, it cannot be determined if they are ApoE ε4 homozygotes and at higher risk for ARIA..

在测试之前，处方医生应与患者讨论不同基因型的ARIA风险以及基因测试结果的意义。处方医生应告知患者，如果不进行基因型测试，他们仍然可以接受LEQEMBI治疗；但无法确定他们是否为ApoE ε4纯合子，以及是否有更高的ARIA风险。

•

•

Consider the benefit of LEQEMBI for the treatment of AD and the potential risk of serious ARIA events when deciding to initiate treatment with LEQEMBI.

在决定开始使用LEQEMBI进行治疗时，应考虑LEQEMBI对AD治疗的益处以及严重ARIA事件的潜在风险。

CONTRAINDICATION

禁忌症

Contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients. Reactions have included angioedema and anaphylaxis.

对lecanemab-irmb或任何辅料有严重过敏反应的患者禁用。过敏反应包括血管性水肿和过敏性休克。

WARNINGS AND PRECAUTIONS

警告和注意事项

AMYLOID-RELATED IMAGING ABNORMALITIES

淀粉样蛋白相关成像异常

Medications in this class, including LEQEMBI, can cause ARIA-E, which can be observed on MRI as brain edema or sulcal effusions, and ARIA-H, which includes microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with AD, particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy (CAA), such as pretreatment microhemorrhage or superficial siderosis.

此类药物（包括LEQEMBI）可能引起ARIA-E（可在MRI上观察为脑水肿或脑沟积液）和ARIA-H（包括微出血和浅表性铁沉积症）。ARIA可自发发生在阿尔茨海默病（AD）患者中，尤其是在磁共振成像发现提示脑淀粉样血管病（CAA）的患者中，例如治疗前微出血或浅表性铁沉积症。

ARIA-H generally occurs with ARIA-E. Reported ARIA symptoms may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms usually resolve over time..

ARIA-H 通常与 ARIA-E 一同发生。报告的 ARIA 症状可能包括头痛、意识模糊、视力变化、头晕、恶心和步态困难。也可能出现局灶性神经功能缺损。症状通常会随着时间的推移而缓解。

Incidence of ARIA

ARIA发生率

Symptomatic ARIA occurred in 3% and serious ARIA symptoms in 0.7% with LEQEMBI. Clinical ARIA symptoms resolved in 79% of patients during the period of observation. ARIA, including asymptomatic radiographic events, was observed: LEQEMBI, 21%; placebo, 9%. ARIA-E was observed: LEQEMBI, 13%; placebo, 2%.

使用LEQEMBI时，3%的患者出现症状性ARIA，0.7%的患者出现严重ARIA症状。在观察期间，79%的患者的临床ARIA症状得到缓解。观察到ARIA（包括无症状的影像学事件）：LEQEMBI组为21%，安慰剂组为9%。观察到ARIA-E：LEQEMBI组为13%，安慰剂组为2%。

ARIA-H was observed: LEQEMBI, 17%; placebo, 9%. No increase in isolated ARIA-H was observed for LEQEMBI vs placebo..

观察到ARIA-H：LEQEMBI组为17%；安慰剂组为9%。与安慰剂相比，LEQEMBI未观察到孤立性ARIA-H的增加。

Incidence of ICH

ICH发病率

ICH >1 cm in diameter was reported in 0.7% with LEQEMBI vs 0.1% with placebo. Fatal events of ICH in patients taking LEQEMBI have been observed.

直径大于1厘米的ICH在LEQEMBI组中报告为0.7%，而安慰剂组为0.1%。在服用LEQEMBI的患者中已观察到致命的ICH事件。

Risk Factors of ARIA and ICH

ARIA和ICH的风险因素

ApoE ε4 Carrier Status

ApoE ε4 携带者状态

Of the patients taking LEQEMBI, 16% were ApoE ε4 homozygotes, 53% were heterozygotes, and 31% were noncarriers. With LEQEMBI, ARIA was higher in ApoE ε4 homozygotes (LEQEMBI: 45%; placebo: 22%) than in heterozygotes (LEQEMBI: 19%; placebo: 9%) and noncarriers (LEQEMBI: 13%; placebo: 4%). Symptomatic ARIA-E occurred in 9% of ApoE ε4 homozygotes vs 2% of heterozygotes and 1% of noncarriers.

在使用LEQEMBI的患者中，16%为ApoE ε4纯合子，53%为杂合子，31%为非携带者。使用LEQEMBI时，ApoE ε4纯合子的ARIA发生率（LEQEMBI：45%；安慰剂：22%）高于杂合子（LEQEMBI：19%；安慰剂：9%）和非携带者（LEQEMBI：13%；安慰剂：4%）。有症状的ARIA-E在ApoE ε4纯合子中发生率为9%，而杂合子为2%，非携带者为1%。

Serious ARIA events occurred in 3% of ApoE ε4 homozygotes and in ~1% of heterozygotes and noncarriers. The recommendations on management of ARIA do not differ between ApoE ε4 carriers and noncarriers..

3%的ApoE ε4纯合子和约1%的杂合子及非携带者发生了严重的ARIA事件。关于ARIA管理的建议在ApoE ε4携带者和非携带者之间没有差异。

Radiographic Findings of CAA

CAA的放射学表现

Neuroimaging findings that may indicate CAA include evidence of prior ICH, cerebral microhemorrhage, and cortical superficial siderosis. CAA has an increased risk for ICH. The presence of an ApoE ε4 allele is also associated with CAA.

可能提示CAA的神经影像学检查结果包括既往ICH、脑微出血和皮质浅表铁沉积症的证据。CAA发生ICH的风险增加。ApoE ε4等位基因的存在也与CAA相关。

The baseline presence of at least 2 microhemorrhages or the presence of at least 1 area of superficial siderosis on MRI, which may be suggestive of CAA, have been identified as risk factors for ARIA. Patients were excluded from Clarity AD for the presence of >4 microhemorrhages and additional findings suggestive of CAA (prior cerebral hemorrhage >1 cm in greatest diameter, superficial siderosis, vasogenic edema) or other lesions (aneurysm, vascular malformation) that could potentially increase the risk of ICH..

在MRI上基线存在至少2个微出血或至少1个浅表性铁沉积区，可能提示CAA，这些已被确定为ARIA的风险因素。Clarity AD研究排除了存在>4个微出血以及提示CAA的其他发现（既往最大直径>1 cm的脑出血、浅表性铁沉积、血管源性水肿）或其他可能增加颅内出血风险的病变（动脉瘤、血管畸形）的患者。

Concomitant Antithrombotic or Thrombolytic Medication

同时使用的抗血栓或溶栓药物

In Clarity AD, baseline use of antithrombotic medication (aspirin, other antiplatelets, or anticoagulants) was allowed if the patient was on a stable dose. Most exposures were to aspirin. Antithrombotic medications did not increase the risk of ARIA with LEQEMBI. The incidence of ICH: 0.9% in patients taking LEQEMBI with a concomitant antithrombotic medication vs 0.6% with no antithrombotic and 2.5% in patients taking LEQEMBI with an anticoagulant alone or with antiplatelet medication such as aspirin vs none in patients receiving placebo..

在Clarity AD试验中，如果患者使用稳定剂量，允许在基线时使用抗血栓药物（阿司匹林、其他抗血小板药物或抗凝剂）。大多数用药为阿司匹林。抗血栓药物并未增加LEQEMBI相关的ARIA风险。颅内出血（ICH）的发生率：同时使用LEQEMBI和抗血栓药物的患者为0.9%，未使用抗血栓药物的患者为0.6%；单独使用抗凝剂或与阿司匹林等抗血小板药物合用的患者为2.5%，而接受安慰剂的患者无发生。

Fatal cerebral hemorrhage has occurred in 1 patient taking an anti-amyloid monoclonal antibody in the setting of focal neurologic symptoms of ARIA and the use of a thrombolytic agent.

接受抗淀粉样蛋白单克隆抗体治疗的患者中，有1名在出现ARIA局灶性神经症状和使用溶栓剂的情况下发生了致命性脑出血。

Additional caution should be exercised when considering the administration of antithrombotics or a thrombolytic agent (e.g., tissue plasminogen activator) to a patient already being treated with LEQEMBI. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy in a patient being treated with LEQEMBI..

在考虑对已接受LEQEMBI治疗的患者使用抗血栓药物或溶栓剂（例如，组织纤溶酶原激活剂）时，应格外谨慎。由于ARIA-E可能引起局灶性神经功能缺损，其症状可能类似于缺血性中风，因此治疗医生应在为接受LEQEMBI治疗的患者进行溶栓治疗前，考虑这些症状是否可能由ARIA-E引起。

Caution should be exercised when considering the use of LEQEMBI in patients with factors that indicate an increased risk for ICH and, in particular, patients who need to be on anticoagulant therapy or patients with findings on MRI that are suggestive of CAA.

在考虑对有提示颅内出血 (ICH) 风险增加因素的患者使用 LEQEMBI 时应谨慎，尤其是需要进行抗凝治疗的患者或核磁共振成像 (MRI) 结果提示可能存在脑淀粉样血管病 (CAA) 的患者。

Radiographic Severity With LEQEMBI

LEQEMBI的放射学严重程度

Most ARIA-E radiographic events occurred within the first 7 doses, although ARIA can occur at any time, and patients can have >1 episode. Maximum radiographic severity of ARIA-E with LEQEMBI was mild in 4%, moderate in 7%, and severe in 1% of patients. Resolution on MRI occurred in 52% of ARIA-E patients by 12 weeks, 81% by 17 weeks, and 100% overall after detection.

大多数ARIA-E影像学事件发生在前7剂内，尽管ARIA可能在任何时候发生，且患者可能经历多次发作。使用LEQEMBI时，ARIA-E的最大影像学严重程度为轻度的患者占4%，中度的占7%，重度的占1%。在ARIA-E患者中，52%在12周内通过MRI显示病灶消退，17周内这一比例达到81%，总体上所有患者在被发现后最终均完全消退。

Maximum radiographic severity of ARIA-H microhemorrhage with LEQEMBI was mild in 9%, moderate in 2%, and severe in 3% of patients; superficial siderosis was mild in 4%, moderate in 1%, and severe in 0.4% of patients. With LEQEMBI, the rate of severe radiographic ARIA-E was highest in ApoE ε4 homozygotes (5%) vs heterozygotes (0.4%) or noncarriers (0%).

使用LEQEMBI时，ARIA-H微出血的最大影像学严重程度为轻度的患者占9%，中度的占2%，重度的占3%；浅表性铁沉积症轻度的占4%，中度的占1%，重度的占0.4%。使用LEQEMBI时，ApoE ε4纯合子患者出现重度影像学ARIA-E的比例最高（5%），而杂合子患者为0.4%，非携带者为0%。

With LEQEMBI, the rate of severe radiographic ARIA-H was highest in ApoE ε4 homozygotes (13.5%) vs heterozygotes (2.1%) or noncarriers (1.1%)..

使用LEQEMBI时，ApoE ε4纯合子的严重放射学ARIA-H发生率最高（13.5%），而杂合子为（2.1%），非携带者为（1.1%）。

Monitoring and Dose Management Guidelines

监测和剂量管理指南

Baseline brain MRI and periodic monitoring with MRI are recommended. Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment. Depending on ARIA-E and ARIA-H clinical symptoms and radiographic severity, use clinical judgment when considering whether to continue dosing or to temporarily or permanently discontinue LEQEMBI.

建议进行基线脑部 MRI 检查并定期通过 MRI 进行监测。在治疗的前 14 周内，建议加强对 ARIA 的临床警惕。根据 ARIA-E 和 ARIA-H 的临床症状和影像学严重程度，在考虑是否继续用药或暂时或永久停用 LEQEMBI 时，请运用临床判断。

If a patient experiences ARIA symptoms, clinical evaluation should be performed, including MRI if indicated. If ARIA is observed on MRI, careful clinical evaluation should be performed prior to continuing treatment..

如果患者出现ARIA症状，应进行临床评估，必要时包括MRI。如果MRI上观察到ARIA，应在继续治疗前进行仔细的临床评估。

HYPERSENSITIVITY REACTIONS

超敏反应

Hypersensitivity reactions, including angioedema, bronchospasm, and anaphylaxis, have occurred with LEQEMBI. Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction and initiate appropriate therapy.

LEQEMBI可引起包括血管性水肿、支气管痉挛和过敏反应在内的超敏反应。一旦观察到任何与超敏反应一致的体征或症状，应立即停止输注，并开始适当的治疗。

INFUSION-RELATED REACTIONS (IRR

输液相关反应 (IRR)

s)

s)

IRRs were observed—LEQEMBI: 26%; placebo: 7%—and most cases with LEQEMBI (75%) occurred with the first infusion. IRRs were mostly mild (69%) or moderate (28%). Symptoms included fever and flu-like symptoms (chills, generalized aches, feeling shaky, and joint pain), nausea, vomiting, hypotension, hypertension, and oxygen desaturation..

观察到的IRR（输注相关反应）发生率分别为：LEQEMBI组26%，安慰剂组7%，且大多数LEQEMBI组病例（75%）发生在首次输注时。IRR大多为轻度（69%）或中度（28%）。症状包括发热和类似流感的症状（寒战、全身酸痛、发抖、关节疼痛）、恶心、呕吐、低血压、高血压以及血氧饱和度下降。

IRRs can occur during or after the completion of infusion. In the event of an IRR during the infusion, the infusion rate may be reduced or discontinued, and appropriate therapy initiated as clinically indicated. Consider prophylactic treatment prior to future infusions with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids..

输液期间或结束后可能会发生IRR。如果在输液期间发生IRR，可以降低输液速度或停止输液，并根据临床指征启动适当的治疗。考虑在未来的输液前使用抗组胺药、对乙酰氨基酚、非甾体抗炎药或皮质类固醇进行预防性治疗。

ADVERSE REACTIONS

不良反应

The most common adverse reactions reported in ≥5% with LEQEMBI infusion every 2 weeks and ≥2% higher than placebo were IRRs (LEQEMBI: 26%; placebo: 7%), ARIA-H (LEQEMBI: 14%; placebo: 8%), ARIA-E (LEQEMBI: 13%; placebo: 2%), headache (LEQEMBI: 11%; placebo: 8%), superficial siderosis of central nervous system (LEQEMBI: 6%; placebo: 3%), rash (LEQEMBI: 6%; placebo: 4%), and nausea/vomiting (LEQEMBI: 6%; placebo: 4%).

每2周一次LEQEMBI输注治疗中，报告发生率≥5%且比安慰剂组高≥2%的最常见不良反应为IRR（LEQEMBI：26%；安慰剂：7%）、ARIA-H（LEQEMBI：14%；安慰剂：8%）、ARIA-E（LEQEMBI：13%；安慰剂：2%）、头痛（LEQEMBI：11%；安慰剂：8%）、中枢神经系统浅表铁沉积症（LEQEMBI：6%；安慰剂：3%）、皮疹（LEQEMBI：6%；安慰剂：4%）以及恶心/呕吐（LEQEMBI：6%；安慰剂：4%）。

Safety profile of LEQEMBI IQLIK for maintenance treatment was similar to LEQEMBI infusion. Patients who received LEQEMBI IQLIK experienced localized and systemic (less frequent) injection-related reactions (mild to moderate in severity)

LEQEMBI IQLIK用于维持治疗的安全性与LEQEMBI输液相似。接受LEQEMBI IQLIK的患者出现了局部和系统性（较少见）注射相关反应（严重程度为轻度至中度）。

LEQEMBI (lecanemab-irmb) is available

LEQEMBI（lecanemab-irmb）已上市

:

：

Intravenous infusion: 100 mg/mL

静脉输注：100毫克/毫升

Subcutaneous injection: 200 mg/mL

皮下注射：200毫克/毫升

Please see full

请查看完整内容

Prescribing Information

处方信息

for LEQEMBI, including Boxed WARNING.

对于LEQEMBI，包括加框警告。

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

玛德琳·辛

+1-781-464-3260

+1-781-464-3260

public.affairs@biogen.com

公共事务@biogen.com

INVESTOR CONTACTS

投资者联系人

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@百健.com

Notes to Editors

编辑须知

1.

1.

About lecanemab (generic name, brand name: LEQEMBI

关于lecanemab（通用名，商品名：LEQEMBI）

®

®

)

)

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). 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..

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，靶向β淀粉样蛋白（Aβ）聚集的可溶性（原纤维）和不可溶形式。原纤维被认为会导致阿尔茨海默病（AD）中的脑损伤，并被认为是毒性最强的 Aβ 形式，在这一渐进性、衰弱性疾病相关的认知衰退中起主要作用。

1

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害。

2

2

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，减少原纤维可能通过减少大脑神经元损伤和认知功能障碍来预防AD的进展。

Lecanemab has been approved in 48 countries and is under regulatory review in 10 countries. In

Lecanemab已在全球48个国家获得批准，并在10个国家接受监管审查。在

January 2025

2025年1月

, the supplemental Biologics License Application (sBLA) for intravenous (IV) maintenance dosing of the treatment was approved in the U.S., and application have been filed in nine (9) countries and regions.

，该治疗药物的静脉注射（IV）维持剂量补充生物制品许可申请（sBLA）已在美国获批，并已在九（9）个国家和地区提交申请。

LEQEMBI's approvals in these countries was based on Phase 3 data from Eisai's, global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB).

LEQEMBI在这些国家的获批是基于卫材全球Clarity AD临床试验的3期数据，该试验达到了主要终点和所有关键次要终点，结果具有统计学意义。主要终点是全球认知和功能量表，即临床痴呆评定总分（CDR-SB）。

In the Clarity AD clinical trial, treatment with lecanemab reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo. The mean CDR-SB score at baseline was approximately 3.2 in both groups. The adjusted least-squares mean change from baseline at 18 months was 1.21 with lecanemab and 1.66 with placebo (difference, −0.45; 95% confidence interval [CI], −0.67 to −0.23; P<0.001).

在Clarity AD临床试验中，与安慰剂相比，使用lecanemab治疗在18个月时使CDR-SB上的临床衰退减少了27%。两组的基线平均CDR-SB评分约为3.2。18个月时，lecanemab组较基线的调整最小二乘均值变化为1.21，安慰剂组为1.66（差异：−0.45；95%置信区间[CI]，−0.67至−0.23；P<0.001）。

In addition, the secondary endpoint from the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL), which measures information provided by people caring for patients with AD, noted a statistically significant benefit of 37% compared to placebo. The adjusted mean change from baseline at 18 months in the ADCS-MCI-ADL score was −3.5 in the lecanemab group and −5.5 in the placebo group (difference, 2.0; 95% CI, 1.2 to 2.8; P<0.001).

此外，次要终点来自阿尔茨海默病合作研究-轻度认知障碍日常生活活动量表（ADCS-MCI-ADL），该量表衡量照顾阿尔茨海默病患者的人所提供的信息，结果显示与安慰剂相比，具有统计学显著性的37%的益处。在18个月时，ADCS-MCI-ADL评分从基线的调整平均变化在lecanemab组为−3.5，在安慰剂组为−5.5（差异：2.0；95%置信区间：1.2至2.8；P<0.001）。

The ADCS MCI-ADL assesses the ability of patients to function independently, including being able to dress, feed themselves and participate in community activities. The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall..

ADCS MCI-ADL评估患者独立生活的能力，包括穿衣、进食和参与社区活动。Lecanemab组最常见的不良事件（>10%）为输液反应、ARIA-H（合并脑微出血、脑大出血和浅表铁沉积症）、ARIA-E（水肿/渗出）、头痛和跌倒。

Since

自从

July 2020

2020年7月

, 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.

，针对临床前阿尔茨海默病（AD）个体的 III 期临床研究（AHEAD 3-45）正在进行中，这些个体在临床上表现为正常，但其大脑中具有中等或较高水平的淀粉样蛋白。AHEAD 3-45 是由阿尔茨海默病临床试验联盟与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）共同开展的公私合作伙伴关系项目，该联盟为美国境内进行的阿尔茨海默病及相关痴呆症的学术临床试验提供基础设施支持。

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单元（DIAN-TU）主导的显性遗传阿尔茨海默病（DIAD）Tau NexGen临床研究，该研究由

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，并将lecanemab作为基础抗淀粉样蛋白疗法。

2.

2.

About the Collaboration between Eisai and Biogen for AD

关于卫材和百健在AD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.

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

自 2005 年以来，卫材和 BioArctic 就 AD 治疗药物的开发和商业化进行了长期合作。根据与 BioArctic 的协议，卫材获得了 lecanemab 用于治疗 AD 的研究、开发、生产和销售的全球权利。

December 2007

2007年12月

. The development and commercialization agreement on the antibody lecanemab back-up was signed in

关于抗体lecanemab备用方案的开发和商业化协议已签署

May 2015

2015年5月

.

。

4.

4.

About Eisai Co., Ltd.

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

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。” 在这一理念下（也被称为

human health care

人类健康护理

(

(

hhc

hhc

) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. 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..

）理念），我们旨在有效实现社会公益，缓解对健康的焦虑，减少健康差异。我们拥有遍布全球的研发设施、制造基地和营销子公司，努力创造并提供创新产品，针对那些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。

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，表明我们致力于消除被忽视的热带病 (NTDs)，这是联合国可持续发展目标 (SDGs) 中目标 3.3 的内容。

For more information about Eisai, please visit

有关卫材的更多信息，请访问

www.eisai.com

www.eisai.com

(for global headquarters: Eisai Co., Ltd.), and connect with us on

（全球总部：卫材株式会社），并通过以下方式与我们联系

X

X

,

，

LinkedIn

领英

and

和

Facebook

Facebook

. The website and social media channels are intended for audiences outside of the UK and

该网站和社交媒体渠道面向英国以外的受众，

Europe

欧洲

. For audiences based in the UK and

. 对于位于英国的观众和

Europe

欧洲

, please visit

，请访问

www.eisai.eu

www.eisai.eu

and Eisai EMEA

和卫材欧洲、中东和非洲地区

LinkedIn

领英

.

。

5.

5.

About Biogen

关于百健科技

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，提供新药以改变患者生活，并为股东和我们的社区创造价值。我们凭借对人类生物学的深刻理解，利用不同的技术模式，推动实现卓越疗效的首创治疗方案或疗法。

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

公司定期在其网站上发布可能对投资者重要的信息，网址为

www.biogen.com

www.biogen.com

. Follow Biogen on social media –

关注Biogen的社交媒体 –

Facebook

Facebook

,

，

LinkedIn

领英

,

，

X

X

,

，

YouTube

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; potential regulatory discussions, submissions and approvals and the timing thereof including for lecanemab-irmb (LEQEMBI IQLIK); the 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声明，包括关于lecanemab潜在临床效果的声明；lecanemab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，包括lecanemab-irmb（LEQEMBI IQLIK）；阿尔茨海默病的治疗；Biogen与Eisai合作安排的预期收益和潜力；Biogen商业业务和管线项目的潜力，包括lecanemab；以及与药物开发和商业化相关的风险和不确定性。

These forward-looking statements may be accompanied by such words as 'aim,' 'anticipate,' 'assume,' 'believe,' 'contemplate,' 'continue,' 'could,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'guidance,' 'hope,' 'intend,' 'may,' 'objective,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'prospect,' 'should,' 'target,' 'will,' 'would,' and other words and terms of similar meaning.

这些前瞻性陈述可能伴随诸如“目标”、“预期”、“假设”、“相信”、“考虑”、“继续”、“可能”、“估计”、“预计”、“预测”、“目的”、“指引”、“希望”、“打算”、“或许”、“目标”、“计划”、“可能”、“潜力”、“预测”、“预计”、“前景”、“应该”、“针对”、“将”、“会”等词语及其他类似含义的词语和术语。

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. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval.

药物开发和商业化涉及高度风险，只有少数研发项目能成功实现产品的商业化。早期临床试验的结果可能无法全面反映后期或更大规模临床试验的完整结果，也无法确保获得监管批准。

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. These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management.

您不应过分依赖这些陈述。鉴于其前瞻性，这些陈述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此类陈述中反映的结果存在重大差异。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。

Given their nature, .

鉴于其性质，。

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及预期、估计或预测的结果有重大差异。

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 .

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可参见我们截至财年结束的10-K表年度报告。

December 31, 2024

2024年12月31日

and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned 'Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in our subsequent reports on Form 8-K. 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..

并在我们后续的10-Q表和10-K表报告中，每种情况下均包括标题为“前瞻性声明说明”和“项目1A. 风险因素”的章节，以及我们在8-K表中的后续报告中。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声明的义务。

References

参考文献

LEQEMBI (lecanemab-irmb) Prescribing Information.

LEQEMBI（lecanemab-irmb）处方信息。

Nutley, NJ

纽特利，新泽西州

: Eisai Inc.

：卫材公司

Iwatsubo T, Irizarry M, van Dyck C, Sabbagh M, Bateman RJ, Cohen S. Clarity AD: a phase 3 placebo-controlled, double-blind, parallel-group, 18-month study evaluating lecanemab in early Alzheimer's disease. Presented at: CTAD Conference;

岩津保、伊里扎里、范戴克、萨巴哈、贝特曼、科恩。Clarity AD：一项评估Lecanemab治疗早期阿尔茨海默病的三期安慰剂对照、双盲、平行组、18个月研究。在CTAD会议上发表；

November 29-December 2, 2022

2022年11月29日-12月2日

;

；

San Francisco, CA.

加利福尼亚州，旧金山。

Hampel H, Hardy J, Blennow K, et al. The amyloid pathway in Alzheimer's disease. Mol Psychiatry. 2021;26(10):5481-5503.

Hampel H, Hardy J, Blennow K, 等。阿尔茨海默病中的淀粉样蛋白通路。《分子精神病学》。2021年；26(10):5481-5503。

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的长期给药数据。可访问：

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

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

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。

Cohen S., et al. J Prev Alzheimers Dis.2022;9(3):507-522.

科恩 S. 等。《阿尔茨海默病预防杂志》。2022年；第9卷（第3期）：507-522页。

Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers.

Amin L, Harris DA. Aβ受体特异性识别纤维末端和神经毒性寡聚体展示的分子特征。

Nat Commun

自然通讯

. 2021;12:3451. doi:10.1038/s41467-021-23507-z.

. 2021;12:3451. doi:10.1038/s41467-021-23507-z.

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

Morris JC。神经病学。1993；43（11）：2412-4。

Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease.

小野健、辻真由美。β-淀粉样蛋白的原纤维是阿尔茨海默病疾病修饰方法的重要靶点。

Int J Mol Sci.

国际分子科学杂志。

2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.

2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.

SOURCE Eisai Inc.

来源：卫材公司

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