Anti-amyloid beta protofibril antibody、Immunoglobulin G1, anti-(human beta-amyloid protofibril) (human-mus musculus monoclonal BAN2401 heavy chain), disulfide with human-mus musculus monoclonal BAN2401 light chain, dimer、lecanemab-irmb

+ [8]

靶点

APP

作用方式

抑制剂

作用机制

APP抑制剂(β-淀粉状蛋白A4抑制剂)

治疗领域

神经系统疾病遗传病与畸形其他疾病

在研适应症

阿尔茨海默病引起的痴呆症轻度认知障碍阿尔茨海默症+ [2]

非在研适应症-

原研机构

在研机构

+ [4]

非在研机构-

权益机构

BioArctic AB

Biogen, Inc.

上海医药集团股份有限公司

+ [1]

最高研发阶段批准上市

首次获批日期

美国 (2023-01-06),

阿尔茨海默症

最高研发阶段(中国)批准上市

特殊审评优先审评 (美国)、突破性疗法 (美国)、快速通道 (美国)、加速批准 (美国)、优先审评 (中国)、创新许可和获取途径 (英国)、优先审评 (日本)

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结构/序列

Sequence Code 315606586L

来源: *****

Sequence Code 315606587H

来源: *****

关联

项与仑卡奈单抗相关的临床试验

NCT07152418

/ Not yet recruitingN/AIIT

A Study on the Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research

Preliminary clinical trial results indicate that Aβ-targeting monoclonal antibody drugs can delay disease progression more effectively. However, some patients still progress slowly to the moderate stage during treatment despite maintaining low Aβ/tau pathological protein loads. For such cases, patients and their families are fully informed about the potential lack of efficacy with continued treatment, and the decision is left to their discretion. Information regarding whether treatment is continued is documented and followed up to determine whether sustained benefits can be achieved. Previous further studies on lecanemab suggest that patients with low or absent tau pathology derive more significant clinical benefits, though large-sample validation remains lacking. This project will therefore enroll patients at clinical stages 3-4 (0.5 ≤ CDR ≤ 1) and monitor those progressing to moderate AD (CDR = 2) during monoclonal antibody therapy. Using tau pathology stratification, the study aims to identify which AD patients are most suitable for monoclonal antibody treatment and evaluate whether therapy continuation yields sustained benefits in patients progressing to moderate dementia, as well as whether patient selection should integrate both pathological (a-c stage) and clinical diagnoses.

开始日期2025-09-01

申办/合作机构

浙江大学医学院附属第二医院（浙江省第二医院）

NCT06992804

/ Recruiting早期临床1期IIT

The Efficacy and Safety of Near-Infrared Light Therapy Combined With Lecanemab for Mild Alzheimer's Disease

The goal of this study is to explore the efficacy and safety of near-infrared light combined with lecanemab in patients with mild Alzheimer's disease (AD).
This study will employ a randomized, double-blind, sham-controlled method with an open-label extension phase. This trial contains the core phase and an extension phase. During the core phase, eligible subjects were selected and randomized (experimental group: control group = 1:1). The subjects who entered the experimental group received treatment with a near-infrared light therapy device combined with lecanemab for 16 weeks. The subjects who entered the control group received treatment with a near-infrared light therapy device simulator (sham stimulation) combined with lecanemab for 16 weeks. After completing the core phase, patients from both groups of the core phase are eligible to enter the extension phase. In the extension phase, all the participants were treated with a near-infrared light therapy device combined with lecanemab up to week 48.

开始日期2025-05-28

申办/合作机构

首都医科大学宣武医院

ChiCTR2500102030

临床4期IIT

Study on the Efficacy and Safety of Luncaner in the Treatment of Moderate to Severe Alzheimer's Disease

开始日期2025-05-01

申办/合作机构-

100 项与仑卡奈单抗相关的临床结果

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100 项与仑卡奈单抗相关的转化医学

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100 项与仑卡奈单抗相关的专利（医药）

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501

项与仑卡奈单抗相关的文献（医药）

2026-02-01·Neural Regeneration Research

Recent advances in immunotherapy targeting amyloid-beta and tauopathies in Alzheimer’s disease

Article

作者: Guo, Wanshu ; Sha, Sha ; Ren, Lina ; Qu, Le ; Li, Ying ; Cao, Yunpeng ; Wang, Yan ; Xing, Xiaona

Alzheimer’s disease, a devastating neurodegenerative disorder, is characterized by progressive cognitive decline, primarily due to amyloid-beta protein deposition and tau protein phosphorylation. Effectively reducing the cytotoxicity of amyloid-beta42 aggregates and tau oligomers may help slow the progression of Alzheimer’s disease. Conventional drugs, such as donepezil, can only alleviate symptoms and are not able to prevent the underlying pathological processes or cognitive decline. Currently, active and passive immunotherapies targeting amyloid-beta and tau have shown some efficacy in mice with asymptomatic Alzheimer’s disease and other transgenic animal models, attracting considerable attention. However, the clinical application of these immunotherapies demonstrated only limited efficacy before the discovery of lecanemab and donanemab. This review first discusses the advancements in the pathogenesis of Alzheimer’s disease and active and passive immunotherapies targeting amyloid-beta and tau proteins. Furthermore, it reviews the advantages and disadvantages of various immunotherapies and considers their future prospects. Although some antibodies have shown promise in patients with mild Alzheimer’s disease, substantial clinical data are still lacking to validate their effectiveness in individuals with moderate Alzheimer’s disease.

2026-02-01·Neural Regeneration Research

Insights into the transcriptomic heterogeneity of brain endothelial cells in normal aging and Alzheimer’s disease

Article

作者: Hoi, Maggie Pui Man ; Lei, Chon Lok ; Yue, Qian ; Wan, Huaibin ; Zhang, Zaijun ; Li, Shang

Drug development for Alzheimer’s disease is extremely challenging, as demonstrated by the repeated failures of amyloid-β-targeted therapeutics and the controversies surrounding the amyloid-β cascade hypothesis. More recently, advances in the development of Lecanemab, an anti-amyloid-β monoclonal antibody, have shown positive results in reducing brain A burden and slowing cognitive decline in patients with early-stage Alzheimer’s disease in the Phase III clinical trial (Clarity Alzheimer’s disease). Despite these promising results, side effects such as amyloid-related imaging abnormalities (ARIA) may limit its usage. ARIA can manifest as ARIA-E (cerebral edema or effusions) and ARIA-H (microhemorrhages or superficial siderosis) and is thought to be caused by increased vascular permeability due to inflammatory responses, leading to leakages of blood products and protein-rich fluid into brain parenchyma. Endothelial dysfunction is an early pathological feature of Alzheimer’s disease, and the blood–brain barrier becomes increasingly leaky as the disease progresses. In addition, APOE4, the strongest genetic risk factor for Alzheimer’s disease, is associated with higher vascular amyloid burden, increased ARIA incidence, and accelerated blood–brain barrier disruptions. These interconnected vascular abnormalities highlight the importance of vascular contributions to the pathophysiology of Alzheimer’s disease. Here, we will closely examine recent research evaluating the heterogeneity of brain endothelial cells in the microvasculature of different brain regions and their relationships with Alzheimer’s disease progression.

2025-09-01·CURRENT PROTEIN & PEPTIDE SCIENCE

Amyloid-β Clearance with Monoclonal Antibodies: Transforming Alzheimer’s Treatment

Article

作者: Khan, Yumna ; Fatima, Rabab ; Ramalingam, Prasanna Srinivasan ; Maqbool, Mudasir ; Bisht, Ajay Singh ; Hussain, Md Sadique ; Khan, Mohammad Gayoor

Alzheimer's disease (AD) is a progressive condition that causes the degeneration of nerve cells, leading to a decline in cognitive abilities and memory impairment, significantly affecting millions around the globe. The primary pathological feature of AD is the buildup of amyloid-β (Aβ) plaques in the brain, which has become a major target for therapeutic strategies. This thorough review examines the progress made in next-generation therapies that concentrate on monoclonal antibodies (mAbs) aimed at Aβ. We explore how these antibodies function, their effectiveness in clinical settings, and their safety profiles, specifically discussing notable mAbs, such as aducanumab, donanemab, lecanemab, etc. This review also addresses the difficulties related to Aβ- targeted treatments. Furthermore, it examines the advancing field of biomarker development and tailored medicine strategies designed to improve the accuracy of AD treatment. By integrating the latest findings from clinical trials and new research, this review offers an in-depth evaluation of the possibilities and challenges associated with mAbs in modifying the progression of AD. Future considerations regarding combination therapies and novel drug delivery methods are also examined, emphasizing the necessity for ongoing research to achieve significant advancements in managing AD. Through this review, we seek to provide clinicians, researchers, and policymakers with insights into the current landscape and future directions of Aβ-targeted therapies, promoting a deeper understanding of their role in addressing AD.

1,957

项与仑卡奈单抗相关的新闻（医药）

2025-09-06

·汇聚南药

诺华，正在下一盘大棋

诺华正在下一盘大棋！近期，诺华大动作频频，不仅以潜在总额53.6亿美元与舶望制药合作开发多款心血管siRNA疗法，还接连加码神经科学领域，先是以超8亿美元与BioArctic合作开发神经退行性疾病新疗法，又斥资22亿美元引进Arrowhead一款治疗帕金森病的siRNA疗法。剥离了仿制药业务后的诺华，开始全力出击siRNA疗法、聚焦创新药，带来了不少看点。 TONACEA 01 全力出击siRNA疗法诺华之所以与舶望制药深化心血管领域合作，背后有着深层逻辑。心血管-肾脏-代谢业务（CRM）是诺华四大核心治疗领域之一，2025年上半年实现收入同比增长26%至51.73亿美元，成为公司第二大收入来源。其中，重磅心衰药物Entresto（沙库巴曲缬沙坦）实现销售额同比增长22%至46.18亿美元，贡献了CRM业务90%的营收，而且占公司总收入的比重近17%%，是诺华第一大支柱产品。不过，作为一款已上市11年的产品，Entresto面临增长乏力困境，加之专利即将到期、仿制药将进入美国市场，以及2026年开始执行医保价格（降幅53%），销售额将受到较大冲击。基于此，诺华在今年3月宣布调整心血管业务的商业化战略，将重心转移至其他高潜力心血管药物，包括销售额保持高速增长的Leqvio（inclisiran，英克司兰钠），以及3款肾病新药：CFB抑制剂Fabhalta（伊普可泮）、ETA拮抗剂EXV811（阿曲生坦）和在研IgA肾病新药Zigakibart。图片来源：华福证券研报为了补充产品管线，诺华还两度携手RNAi赛道黑马舶望制药：先是就两款心血管siRNA药物达成潜在总额超41亿美元的合作，又在近期就四款siRNA管线达成总额超53亿美元的合作。根据近期达成的合作协议，舶望制药将授予诺华两款处于发现阶段的下一代siRNA分子（针对重度高甘油三酯血症及混合性血脂异常）的中国境外许可权、一款正在中美两地开展II期临床的BW-00112（ANGPTL3 siRNA）的优先谈判权、一款预计2026年启动Ⅰ期研究的siRNA候选药物的中国境外许可权。不得不说，诺华对siRNA疗法是真爱啊。毕竟，长效PCSK9 siRNA降血脂新药Leqvio，自上市以来一直保持高速增长态势，让诺华尝到了甜头，2025年上半年，实现销售额同比增长66%至5.55亿美元，今年有望成为“十亿美元分子”。 Leqvio成功验证了siRNA在慢病领域的商业化潜力，并推动其他RNAi疗法探索高血压、糖尿病等。例如，罗氏和Alnylam在近期宣布，将启动一项III期心血管结局试验（CVOT），以评估RNAi疗法Zilebesiran降低未控制高血压患者发生重大心血管不良事件风险的能力。值得注意的是，siRNA疗法还有望拓展至中枢神经系统（CNS）疾病领域。就在近期，诺华以潜在总额22亿美元从Arrowhead引进了一款治疗帕金森病的临床前阶段siRNA疗法。此次合作，不仅彰显了诺华在siRNA药物领域的深度布局，更暗藏其抢占下一个“黄金赛道”的野心。 TONACEA 02 持续加码神经科学除了CRM业务，神经科学也是诺华四大核心治疗领域之一：2025年上半年，实现收入同比增长23%至27.59亿美元，占公司总收入比例提升至10.11%。诺华在神经科学领域的主要产品包括：CD20单抗Kesimpta（奥法妥木单抗）、一次性基因疗法Zolgensma（OAV101），2024年分别实现销售额32.24亿美元（+49% ）、12.14亿美元（+2%）。 Kesimpta适用于成人复发型多发性硬化（RMS）。多发性硬化（MS）是一种免疫介导的中枢神经系统炎性脱髓鞘疾病。凭借居家注射的便利性，Kesimpta保持强劲的增长势头，2025年上半年同比增长38%至19.76亿美元，验证了B细胞疗法的市场认可度。 Zolgensma是诺华87亿美元收购AveXis所获得的一种基于腺相关病毒（AAV）载体的基因治疗药物，也是基因疗法领域的首款“重磅炸弹”，用于治疗罕见病脊髓性肌萎缩症（SMA），每剂210万美元（约合人民币1500万元）。不过，由于市场天花板可见、天价带来的市场准入与支付压力及市场竞争加剧等原因，这两年Zolgensma销售额持续下滑，2025年上半年实现收入同比下降3.11%至6.24亿美元。可见，诺华的神经科学业务出现了与CRM业务类似的情况：亟待新品补位。图片来源：方正证券研报基于此，诺华开启了“买买买”模式：2024年，以11亿美元收购Kate Therapeutics，拓展神经基因治疗领域战略布局；2025年，以超8亿美元与BioArctic合作开发神经退行性疾病新疗法，以22亿美元引进Arrowhead的帕金森病siRNA疗法。纵观其战略布局，诺华在神经科学领域的规划极具前瞻性，旨在抢占下一代治疗技术的制高点。例如，诺华选择收购Kate Therapeutics，是为了显著增强其在基因疗法和神经科学创新领域的战略布局。 Kate专注于开发基于AAV的基因疗法，用于治疗遗传性神经肌肉疾病，包括杜氏肌营养不良症（DMD）、面肩肱型肌营养不良症（FSHD），其中最成熟的候选药物KT430，已授权安斯泰来合作开发，用于治疗X连锁肌管性肌病。与诺华达成授权合作的BioArctic大有来头，后者专注于可以延缓或阻止神经退行性疾病进展的创新疗法。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——仑卡奈单抗（lecanemab，Leqembi），正是由BioArctic发现了原型抗体mAb158（仑卡奈单抗的前身），并与负责后期开发、临床试验和商业化的卫材共同开发的。更关键的是，我们还能从诺华引进帕金森siRNA疗法窥见其差异化战略。 TONACEA 03 将差异化进行到底诺华的差异化战略，体现在不追热门的ADC、GLP-1赛道，而是“绕过红海、开辟蓝海”，深度布局核药、小核酸药物、细胞与基因疗法。尤其在核药领域，诺华已经尝到了大甜头：Pluvicto已在2024年成为“重磅炸弹药物”；另一款核药Lutathera今年上半年实现销售额同比增长16%至4亿美元，也有望成为“十亿美元分子”。为了加强在放射性配体疗法（RLT）领域的领导地位，诺华一直在“买买买”，去年还收购Mariana Oncology，拿下了针对小细胞肺癌（SCLC）的基于锕的先导RLT项目MC-339。而在小核酸药物板块，诺华主要布局反义寡核苷酸（ASO）和小干扰RNA（siRNA），今年还斥资17亿美元收购肾脏疾病药物研发公司Regulus，获得已进入III期临床的miRNA药物Farabursen。 Farabursen是针对miR-17靶点的下一代寡核苷酸，用于治疗常染色体显性遗传性多囊肾病（ADPKD）这一严重的肾脏疾病。诺华药品开发部总裁兼首席医学官Shreeram Aradhye表示，“目前ADPKD患者的治疗选择有限，Farabursen作为一种潜在的首创药物，有望在疗效、耐受性和安全性方面优于现有的标准治疗方案。ADPKD是全球范围内，引起肾衰竭最常见的遗传性原因。” 图片来源：方正证券研报针对siRNA疗法，诺华还将触手伸至CNS领域。此前，艾伯维扬言“明年将成为业内最大的CNS公司”，诺华自然不甘落后。在帕金森病治疗领域，艾伯维拥有Duodopa（左旋多巴/卡比多巴凝胶）和销售峰值有望超20亿美元的帕金森病复方疗法Vyalev，并收购Cerevel Therapeutics拿下了多巴胺D1/D5受体部分激动剂Tavapadon；反观诺华选择siRNA疗法突围路线，将差异化进行到底。诺华斥资22亿美元引进的ARO-SNCA，便是一款临床前阶段的siRNA疗法，利用Arrowhead专有靶向RNAi分子（TRiM™）平台进行皮下给药和向中枢神经系统递送，旨在靶向编码α-突触核蛋白的基因，作为帕金森病和其他突触核蛋白病患者的潜在治疗方法。诺华生物医学研究总裁FionaMar shall表示：“帕金森病等神经退行性疾病影响着全球数百万患者。我们认为ArrowheadTRiM™技术具有巨大潜力，可在关键的大脑结构中实现广泛有效的递送，这对于看到RNA药物在神经退行性病变中的全面益处是必要的。” 正如Leqvio开创了siRNA用于慢性病的新时代，诺华此举也是为了防止在下一代CNS疗法中掉队。若能成功，ARO-SNCA将重塑帕金森病治疗范式，并为诺华带来可观的收入。此次合作，诺华还将在TRiM™平台开发的产品线之外选择其他合作靶点。可见，TRiM™平台是“会下金蛋的鸡”，诺华看中的是其持续制造“重磅炸弹药物”的潜力。如此看来，诺华选择重金投入，既是进攻性的开疆拓土，也是防御性的战略卡位。 — 结语 — 在巨头林立的创新药竞赛中，诺华选择了一条差异化且极具前瞻性的突围路径。这一选择的核心驱动力源于对核心产品增长乏力的未雨绸缪。为此，诺华启动了“买买买”模式、双线并行的“补位”战略。这种聚焦于小核酸、核药等前沿领域的选择，既规避了同质化竞争，又通过深耕技术驱动的创新路径，为其构建了独特的长期壁垒与护城河。参考资料： 1.诺华的财报、公告、官微 2.《20250822-医药生物行业：诺华2025H1业绩超预期，小核酸药物Leqvio增速领跑》，方正证券研报 3.华福证券研报喜欢我们文章的朋友点个“在看”和“赞”吧，不然微信推送规则改变，有可能每天都会错过我们哦~ 免责声明 “汇聚南药”公众号所转载文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请在留言栏及时告知，我们会在24小时内删除相关信息。信息来源：同写意往期推荐本平台不对转载文章的观点负责，文章所包含内容的准确性、可靠性或完整性提供任何明示暗示的保证。

siRNA临床3期

2025-09-05

·FiercePharma

Fierce Pharma Asia—Novartis' $5B Argo deal; Eisai's subcutaneous Leqembi nod; HKEX chastises Henlius

Novartis' siRNA deal with Argo Biopharmaceutical, the FDA's approval for Leqembi Iqlik and the Hong Kong Stock Exchange's sanctions against Shanghai Henlius Biotech and its former CEO made our news this week. Novartis is tapping into Argo Biopharmaceutical's siRNA capabilities again in a deal worth up to $5.2 billion. The FDA approved a subcutaneous version of Eisai and Biogen's Leqembi. The Hong Kong Stock Exchange issued sanctions against Shanghai Henlius Biotech and its former CEO over a questionable reallocation of IPO proceeds. And more.1. Novartis returns to Argo for multifaceted $5B cardiovascular collabNovartis has returned to China siRNA biotech Argo Biopharmaceutical for more cardiovascular assets. In a deal potentially worth $5.2 billion, Novartis gained options to two discovery-stage molecules for severe hypertriglyceridemia and mixed dyslipidemia, plus a right of first negotiation to ANGPTL3—an RNAi therapeutic—following a combination trial in dyslipidemia. Argo gets $160 million upfront in the deal.2. Eisai secures FDA green light for Leqembi autoinjector, teeing up at-home maintenance dosingThe FDA has approved a subcutaneous version of Eisai and Biogen’s Leqembi as maintenance treatment for Alzheimer’s disease. The drug, called Leqembi Iqlik, is given once a week via an autoinjector. Eisai hopes the more convenient formulation could save healthcare resources and increase uptake of the medicine. The company also initiated an FDA rolling submission for Leqembi Iqlik as a starting dose.3. Hong Kong exchange disciplines Henlius over $117M asset management lapse (PDF)The Hong Kong Stock Exchange is censuring Shanghai Henlius Biotech and sending its former CEO Scott Shi-Kau Liu to 26 hours of training on regulations and listing compliance rules. The issue dates back to the biotech’s IPO in 2019. The exchange found that Henlius and Liu breached its rules by redirecting $117 million, or 29% of the biotech’s IPO proceeds, to a questionable investment vehicle even though such use was not listed in Henlius’ prospectus. Liu greenlighted the deal, signed on the day of the IPO by Henlius’ then-Chief Financial Officer Zidong Zhang, Ph.D., without examining the agreement document or bringing the matter to the board for consideration. Henlius and Liu did not contest their respective breaches and agreed to their sanctions, according to the exchange.4. Amgen-Zai stomach cancer candidate takes a turn with 'attenuated' OS benefits at final phase 3 analysisThe overall survival benefit observed for Amgen and Zai Lab’s anti-FGFR2b drug bemarituzumab in a phase 3 stomach cancer trial has “attenuated,” Zai said. The study, coded Fortitude-101, tested adding the drug to chemotherapy in first-line, HER2-negative gastric or gastroesophageal junction cancer with FGFR2b overexpression. Back in June, the pair said the study met its primary endpoint of overall survival at an interim analysis.5. AstraZeneca, exiting production digs in India, surrenders local manufacturing licenseAstraZeneca has handed in its manufacturing license in India as the British pharma plans to exit from its lone production facility in the country. In 2023, the company disclosed its intent to shutter its Bengaluru plant “in due course.” After failing to find a suitable contract manufacturer to take over the place, the company is still aiming to sell the facility. 6. India’s drug regulator eyes lighter oversight, more AI to boost efficiency (Reuters)To increase efficiency, India’s drug regulator is working to reduce certain requirements and processing time. “We’re trying to increase our efficiency, cutting down on regulations so that we create more and more resources within our system,” the Central Drugs Standard Control Organisation's Rajeev Raghuvanshi told Reuters on the sidelines of an industry event.Other News of Note: 7. Lilly links up with JD Health for DTC obesity, diabetes drug sales in China8. Korean ADC developers debate strategies to counter China’s rapid rise (Korea Biomedical Review)9. Roche’s Chugai adds new safety measure for Sarepta’s Elevidys in Japan (Regulatory tracker)10. Fosun rises again, inking 3rd inflammatory disease deal in 3 weeks11. Henlius, Organon win FDA nods for biosimilars to Amgen’s Prolia, Xgeva (Release)

临床3期引进/卖出上市批准IPO临床结果

2025-09-05

·医药观澜

速递丨卫材向FDA提交仑卡奈单抗皮下注射剂型的滚动补充生物制品许可申请

9月4日，卫材（Eisai）和渤健（Biogen）宣布，卫材已启动向美国FDA提交仑卡奈单抗皮下自动注射剂型（SC-AI）IQLIK作为每周起始剂量的滚动补充生物制品许可申请（sBLA），此前FDA已授予快速通道资格。仑卡奈单抗用于治疗患有轻度认知障碍及轻度痴呆的早期阿尔茨海默病（AD）患者。此次补充生物制品许可申请（sBLA）的提交基于，针对早期阿尔茨海默病患者群体开展的18个月核心研究后、在3期Clarity AD开放标签扩展研究（OLE）的子研究中对皮下（SC）给药方式在多剂量范围内的评估。若美国FDA批准仑卡奈单抗IQLIK 500mg皮下给药方案（两次250mg注射），该自动注射剂型可用于每周一次的起始剂量给药，作为每两周一次静脉注射（IV）的替代方案。这将使患者及照料者能够从治疗初始到维持阶段在家接受仑卡奈单抗治疗，提供静脉注射与皮下注射两种给药方式的选择。目前每支仑卡奈单抗IQLIK自动注射剂型的注射时间约为15秒。皮下制剂有望减少与静脉维持给药相关的输液准备和护士监护等环节，同时简化阿尔茨海默病的整体治疗流程。仑卡奈单抗目前已在48个国家获批上市，并在10个国家处于审评审批阶段。仑卡奈单抗的全球开发和注册申请由卫材主导，而产品则由卫材和渤健共同商业化和推广。其中，卫材拥有最终决策权。参考资料：[1]卫材在快速通道资格下向FDA提交仑卡奈单抗IQLIK的滚动补充生物制品许可申请. From https://www.prnasia.com/story/502124-1.shtml免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

快速通道上市批准临床3期

100 项与仑卡奈单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	仑卡奈单抗	-	DB14580

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
阿尔茨海默病引起的痴呆症	英国	Eisai Europe Ltd.	2024-08-22
轻度认知障碍	英国	Eisai Co., Ltd.	2024-08-22
阿尔茨海默症	美国	Eisai, Inc.	2023-01-06

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
认知功能障碍	临床1期	日本	Eisai Co., Ltd.	2013-09-01
创伤性脑损伤	临床前	美国	BioArctic AB	2023-11-15
唐氏综合征	临床前	美国	BioArctic AB	2023-11-15

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01767311 (FDA_CDER) 人工标引	临床2期	阿尔茨海默症	856	LEQEMBI 10 mg/kg Every Two Weeks	顧壓範網構鏇選鹹範願(衊蓋網網窪顧遞艱憲願) = LEQEMBI had a 64% likelihood of 25% or greater slowing of progression on the primary endpoint relative to placebo at Week 53, which did not meet the prespecified success criterion of 80%. 繭鑰鬱蓋選選顧醖鑰蓋 (壓觸壓網遞網鑰範艱夢 )	-	2025-08-29
				Placebo
NCT03887455 (Clarity AD, NEWS) 人工标引	临床3期	阿尔茨海默症	-	Leqembi	鏇廠鹽觸繭網選顧製網(顧遞構構範襯廠壓選選) = 膚鬱壓鬱襯壓顧遞廠鏇衊壓餘糧夢積夢積糧遞 (膚觸襯餘繭築餘願觸齋 )	积极	2025-08-12
				placebo	鏇廠鹽觸繭網選顧製網(顧遞構構範襯廠壓選選) = 艱網衊鏇積夢膚觸壓鑰衊壓餘糧夢積夢積糧遞 (膚觸襯餘繭築餘願觸齋 )
Company_Website 人工标引	N/A	阿尔茨海默症	178	Lecanemab	鏇鹽範積蓋鹹艱窪艱選(夢鑰獵窪築壓蓋淵糧膚) = 83.6% of patients either remained at the same clinical stage or improved from mild dementia to MCI (stable: 76.9%, improvement: 6.7%) 範積簾衊窪遞醖鑰遞糧 (選觸構襯衊顧積鹹鹽鑰 ) 更多	积极	2025-07-30
NCT03887455 (Clarity AD OLE, Company_Website) 人工标引	N/A	阿尔茨海默症维持	-	lecanemab-irmb SC	獵廠夢齋醖壓餘選鹹鏇(獵壓膚構觸獵製構願醖) = Data supports that transitioning to a weekly 360 mg SC AI dose of lecanemab after 18 months of initiation dose (10 mg/kg IV biweekly) maintains clinical and biomarker benefits comparable to continued biweekly IV dosing. Clinical and biomarker responses at 48 months with monthly IV maintenance dosing are similar to the responses with ongoing biweekly dosing whether patients are amyloid positive (>30 CL) or negative (<30 CL) at 18 months. Data shows the 500 mg SC AI has equivalent exposure as the initial treatment regimen of 10 mg/kg IV biweekly up to 18 months for amyloid removal, efficacy, and ARIA-E. 繭觸鏇糧網鬱鬱衊積衊 (鑰鏇憲製製選製鹹顧鬱 ) 更多	积极	2025-07-30
				lecanemab IV
P12-3.019 (AAN2025)	N/A	-	-	Lecanemab	憲選積顧製鑰膚夢襯廠(鹽遞鬱繭壓憲鑰鏇鹽壓) = 鏇獵鹽鏇築齋夢餘願製簾範遞艱鬱繭衊簾蓋選 (廠壓選鬱憲鹹齋鏇顧蓋, 91.1)	-	2025-04-07
NCT03887455 (Clarity AD, PRNewswire) 人工标引	临床3期	阿尔茨海默症	1,795	lecanemab	顧餘膚艱積製選襯醖構(獵鏇廠艱選壓範鏇鬱鏇) = 鹽積構蓋齋鹹膚鏇繭壓鑰顧壓壓築鹹顧醖膚糧 (鑰醖壓顧鑰顧艱遞鹹積 ) 更多	积极	2024-07-30
				Placebo	顧餘膚艱積製選襯醖構(獵鏇廠艱選壓範鏇鬱鏇) = 襯簾築願繭糧築淵鹽鏇鑰顧壓壓築鹹顧醖膚糧 (鑰醖壓顧鑰顧艱遞鹹積 ) 更多
NCT03887455 (Clarity AD, Pubmed \| Alzheimers Res Ther) 人工标引	临床3期	阿尔茨海默症 ApoE e4 carriers \| ApoE ε4 homozygous participants	3,407	Lecanemab 10 mg/kg biweekly	鬱範衊齋壓醖窪鏇簾襯(製糧鏇簾醖膚築範遞積) = 獵襯鏇鑰廠蓋壓夢簾糧窪簾積網築網繭艱廠壓 (鹽鏇壓鹽顧糧艱壓繭夢 ) 更多	积极	2024-05-10
				placebo (Core Study)	網鏇淵觸廠壓遞鬱廠艱(構齋遞獵醖網蓋糧鹹餘) = 襯範鑰醖鑰鑰襯築蓋窪鑰鬱積遞顧襯鑰選衊餘 (遞鏇襯鬱廠鬱獵廠膚選 )
NCT03887455 (Clarity AD, AAN2024)	临床3期	阿尔茨海默症 amyloid PET centiloid levels	-	Lecanemab 10 mg/kg biweekly	鏇範獵觸鏇夢遞窪遞積(艱齋鬱衊觸鬱襯鑰夢製) = 蓋膚壓糧餘觸範齋觸鏇蓋齋襯製網襯鏇鑰範醖 (壓鬱鑰淵蓋蓋鏇襯鹽築 )	积极	2024-04-09
				Placebo	鏇範獵觸鏇夢遞窪遞積(艱齋鬱衊觸鬱襯鑰夢製) = 鹹鏇艱構遞遞鹹膚餘鬱蓋齋襯製網襯鏇鑰範醖 (壓鬱鑰淵蓋蓋鏇襯鹽築 )
NCT03887455 (Clarity AD, PRNewswire \| NEWS \| Corporate Publications) 人工标引	临床3期	阿尔茨海默症	898	LEQEMBI (SC)	衊齋糧鹽醖夢觸選艱夢(鹹鹹遞糧窪範範製範蓋) = 淵願淵膚醖範衊顧夢襯鏇製齋壓醖願齋鏇繭範 (廠積鏇廠醖範憲構糧網, 2.27) 更多	积极	2023-10-25
				LEQEMBI (IV)	衊齋糧鹽醖夢觸選艱夢(鹹鹹遞糧窪範範製範蓋) = 簾鹽選鏇餘鏇齋鏇積襯鏇製齋壓醖願齋鏇繭範 (廠積鏇廠醖範憲構糧網, 1.14) 更多
NCT03887455 (Clarity AD, FDA) 人工标引	临床3期	阿尔茨海默症 ApoE ε4	1,464	LEQEMBI 10 mg/kg	夢選廠夢夢獵淵網憲衊(艱鑰淵顧簾鏇鹽壓簾壓) = 衊觸衊鏇齋壓夢築廠壓繭壓糧憲襯鏇艱顧鏇範 (淵獵鏇艱糧築醖夢齋夢 ) 达到更多	积极	2023-01-06
				Placebo	夢選廠夢夢獵淵網憲衊(艱鑰淵顧簾鏇鹽壓簾壓) = 鹽襯製顧齋簾鹹廠繭醖繭壓糧憲襯鏇艱顧鏇範 (淵獵鏇艱糧築醖夢齋夢 ) 达到更多