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

+ [9]

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

轻度痴呆阿尔茨海默病引起的痴呆症轻度认知障碍+ [3]

非在研适应症-

原研机构

BioArctic AB

在研机构

Eisai GmbHBiogen U.S. Corp.

Eisai Co., Ltd.

+ [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

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

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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

NCT07212062

/ Not yet recruiting临床2期IIT

A Phase II, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Sfatey and Tolerability of X/T+X-EC vs. Placebo in Participants With Alzheimer's Disease Currently Treated With Lecanemab.

The goal of the trial is to see if the Safety and Tolerability of X/T+X/T-EC combined with currently treated Lecanemab participants with Alzheimer's Disease compared with placebo. This is a 32 week study (4 weeks of screening,24 weeks of treatment and 4 weeks of safety follow up)

开始日期2025-12-01

申办/合作机构

Bristol Myers Squibb Co.

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

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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662

项与仑卡奈单抗相关的文献（医药）

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

A value assessment of patient-level outcomes and productivity loss for intravenous and subcutaneous lecanemab for patients with early Alzheimer’s disease

Review

作者: Graham, Laura ; Chowdhury, Emtiyaz ; Ressa, Riccardo ; Mancebo, Julen Zabala ; Ndirangu, Kerigo ; Ettinger, Jack ; Bodnar, Carolyn

AIMS:

Intravenous (IV) lecanemab is approved for the treatment of patients with early Alzheimer's disease (AD); a subcutaneous (SC) option may offer additional benefits. We assessed the overall value of SC treatments, and direct/indirect outcomes associated with IV and SC lecanemab.

METHODS AND MATERIALS:

For the narrative review, PubMed was searched (February 2025) for studies comparing patient preferences for IV/SC treatment administration published between 2015-2025. Study eligibility was determined using patient, intervention, comparator, outcomes, and study criteria. For the decision-analytic model, a Markov model was developed with four lecanemab treatment scenarios. Scenarios one to three included IV initiation (10 mg/kg biweekly) to month 18, followed by either IV initiation continued (10 mg/kg biweekly), SC maintenance (250 mg weekly) or IV maintenance (10 mg/kg every 4 weeks). Scenario four included SC initiation (500 mg weekly) for an 18-month period, followed by SC maintenance (250 mg weekly). Outcomes were administration time/frequency; patient, caregiver, and healthcare professional time; and caregiver productivity loss.

RESULTS:

Forty-three publications reported patient treatment preferences. Most (88.4%) reported that patients preferred SC over IV. Key reasons for this were time savings (n = 13/43 studies; 30.2%), convenience (n = 11/43; 25.6%), treatment frequency (n = 12/43; 27.9%). Two studies (n = 2/43; 4.7%) reported an IV preference over SC; for three studies (n = 3/43; 7.0%), treatment preference was driven by administration frequency. Decision-analytic modeling of lecanemab treatment scenarios revealed that IV initiation to IV maintenance had the lowest number of administrations, whereas SC initiation to SC maintenance had the lowest number of treatment hours and caregiver productivity losses.

LIMITATIONS:

Caution must be taken when generalizing these results for all AD patients.

CONCLUSIONS:

SC treatments show value as a therapeutic option. IV and SC lecanemab availability may offer benefits to patients, caregivers, and society, and improve shared decision making.

2026-03-01·MOLECULAR AND CELLULAR NEUROSCIENCE

Precision therapeutic strategies for Alzheimer's disease: Amyloid β–targeted foundations and multimodal next-generation approaches

Review

作者: Khan, Muhammad Sohail ; Shafiq, Shaista ; Zafar, Imran ; Jamal, Adil ; Khan, Najeeb Ullah ; Bahwerth, Fayez Saeed

Alzheimer's disease (AD) is the leading cause of dementia and a significant unmet medical challenge, pathologically characterized by amyloid β (Aβ) aggregation, tau hyperphosphorylation, synaptic dysfunction, and chronic neuroinflammation. Although Aβ has long been a central therapeutic target, clinical translation has historically been hindered by late-stage intervention, inadequate blood-brain barrier (BBB) penetration, and the molecular heterogeneity of AD. Recent advances with Aβ-targeted monoclonal antibodies, particularly lecanemab and donanemab, have provided the first clinical evidence of disease modification, demonstrating robust amyloid clearance and measurable slowing of cognitive decline in early-stage AD. These results validate the Aβ hypothesis but also highlight persistent barriers, including amyloid-related imaging abnormalities (ARIA), questions about the durability of benefit, challenges in patient stratification, and the high economic burden of biologics. To overcome these limitations, next-generation strategies are emerging that extend beyond single-pathway targeting toward multimodal and precision-based frameworks. Innovative approaches include tau-directed therapies to prevent the propagation of neurofibrillary tangles, immunomodulatory strategies to enhance microglial clearance of aggregated proteins, and neuroprotective interventions to counteract oxidative and inflammatory stress. Concurrently, nanotechnology-based drug delivery systems are being engineered to efficiently traverse the BBB and deliver multifunctional payloads, while artificial intelligence (AI)- driven discovery platforms are accelerating target identification, biomarker integration, and patient stratification. Future perspectives emphasize the importance of preclinical-stage intervention, long-term efficacy trials, and the adoption of personalised treatment paradigms that integrate genomic, biomarker, and digital profiling to optimise outcomes. Collectively, these advances signal a paradigm shift in AD therapeutics, positioning Aβ-targeted therapies as a foundation while paving the way for combination strategies that more effectively address the disease's multifactorial nature.

2026-03-01·JPAD-Journal of Prevention of Alzheimers Disease

A regional framework for the detection and management of ARIA with anti-amyloid therapies in early Alzheimer’s disease in Asia

Article

作者: Inaba, Kaori ; Chen, Ta-Fu ; Moon, Won Jin ; Kandiah, Nagaendran ; Kumar, Sumeet ; Park, Young Ho ; Dash, Amitabh ; Lee, Bo-Ching ; Moon, So Young

Alzheimer's disease (AD) is a growing public health concern in Asia, with an increasing prevalence driven by demographic shifts and rising life expectancy. The introduction of anti-amyloid monoclonal antibodies such as lecanemab and donanemab marks a pivotal transition from symptomatic management of AD to disease-modifying approaches, but their clinical use requires careful monitoring for amyloid-related imaging abnormalities (ARIA), a key safety consideration that presents either as vasogenic edema or as microhemorrhages and superficial siderosis. ARIA has been observed in varying frequencies across global and Asian clinical trial populations, underscoring the need for region-specific guidance. With our early clinical experiences in South Korea, Taiwan and Singapore serving as archetypes in Asia, we outline a framework for the detection and management of ARIA in Asian healthcare settings, accounting for disparities in imaging infrastructure, genetic factors, and clinician experience. Pre-treatment risk stratification, standardized imaging protocols, and severity-based treatment modifications are central to the framework, highlighting the critical role of multidisciplinary collaboration involving neurologists, geriatricians, psychiatrists, and radiologists in ensuring accurate detection and management of ARIA. Additionally, the paper highlights the role of pharmacovigilance, real-world evidence generation, physician education, and healthcare system preparedness in optimizing the safety and efficacy of anti-amyloid therapies in Asia. The proposed framework aims to ensure safe and effective use of anti-amyloid therapies while mitigating ARIA-related risks, thereby optimizing therapeutic outcomes for early AD in diverse healthcare settings across Asia.

2,523

项与仑卡奈单抗相关的新闻（医药）

2026-01-27

·PRNewswire

Leqembi® Iqlik™ (lecanemab-irmb) supplemental Biologics License Application regarding subcutaneous starting dose granted Priority Review by the US FDA

Jan. 25, 2026 -- BioArctic AB's (publ) (STO: BIOA B) partner Eisai announced today that the supplemental Biologics License Application (sBLA) for Leqembi Iqlik subcutaneous autoinjector (SC-AI) as a weekly starting dose has been granted Priority Review by the U.S. Food and Drug Administration (FDA). Leqembi is indicated for the treatment of Alzheimer's disease in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early Alzheimer's disease). A Prescription Drug User Fee Act (PDUFA) action date is set for May 24, 2026. If approved, Leqembi Iqlik would be the first and only anti-amyloid treatment to offer at-home injection options for initiation and maintenance dosing for this progressive, relentless disease. Should the FDA approve the Leqembi Iqlik 500 mg subcutaneous (SC) dosing regimen (two 250 mg injections), the autoinjector could be used to administer a once-weekly starting dose, as an alternative to the current bi-weekly intravenous (IV) dosing. This would enable patients and care partners to choose SC administration at home for both treatment initiation and the currently approved maintenance therapy (360 mg), offering the option of SC or IV administration throughout the entire treatment journey. The injection time for each Leqembi Iqlik autoinjector takes approximately 15 seconds per each 250 mg injection. The SC formulation also has the potential to reduce healthcare resources associated with IV dosing, such as infusion preparation and nurse monitoring, while streamlining the overall Alzheimer's disease treatment pathway. The sBLA is supported by data evaluating SC administration of lecanemab across a range of doses and as part of sub-studies within the Phase 3 Clarity Alzheimer's disease open-label extension (OLE) following the 18-month core study in individuals with early Alzheimer's disease. Data show that once-weekly administration of the 500 mg of SC-AI achieved equivalent exposure to once every two weeks IV administration and similar clinical and biomarker benefits. SC administration demonstrated a safety profile similar to IV administration, with less than 2% incidence of systemic injection or infusion-related reactions. Alzheimer's disease is a progressive, relentless disease, with amyloid beta (Aβ) and tau as hallmarks, that is caused by a continuous underlying neurotoxic process driven by protofibrils* (PF) that begins before amyloid plaque removal and continues afterward[1],[2],[3]. Only Leqembi fights Alzheimer's disease in two ways – targeting both PF and amyloid plaque, which can impact tau downstream. 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 is approved in 53 countries and is under regulatory review in 7 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks is approved in the United Kingdom, China, the U.S. and other countries, and applications have been filed in 4 countries and regions. In the U.S., Leqembi Iqlik™ is approved for subcutaneous dosing with an autoinjector for maintenance treatment of early Alzheimer's disease (AD). In November 2025, a rolling sBLA application to the U.S. FDA for the subcutaneous initiation dosing with Leqembi Iqlik was also completed and a new drug application for subcutaneous formulation of Leqembi was submitted in Japan. In December 2025, Lecanemab has been included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China. Since July 2020, 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 October 2024. 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 AD and related dementias in the U.S., funded by the National Institute on Aging, part of the National Institutes of Health. 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. 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. 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. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with sales milestones as well as royalties on global sales. 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. 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. 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. [1] Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z. [2] 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. [3] Hampel H, Hardy J, Blennow K, et al. The amyloid-β pathway in Alzheimer's disease. Mol Psychiatry. 2021;26(10):5481-5503. The content above comes from the network. if any infringement, please contact us to modify.

上市批准引进/卖出优先审批临床结果

2026-01-27

·PRNewswire

FDA Accepts LEQEMBI® IQLIKTM (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease under Priority Review

Jan. 25, 2026 -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the U.S. Food and Drug Administration (FDA) has accepted for review Eisai's Supplemental Biologics License Application (sBLA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector (SC-AI), LEQEMBI IQLIK, as a weekly starting dose. LEQEMBI is indicated 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). The sBLA has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of May 24, 2026. Should the FDA approve the LEQEMBI IQLIK 500 mg SC dosing regimen (two 250 mg injections), the autoinjector could be used to administer a once-weekly starting dose, as an alternative to the current bi-weekly intravenous (IV) dosing. This would enable patients and care partners to choose SC administration at home for both treatment initiation and the currently approved maintenance therapy (360 mg), offering the option of SC or IV administration throughout the entire treatment journey. The injection time for LEQEMBI IQLIK autoinjector takes approximately 15 seconds per each 250 mg injection. The SC formulation also has the potential to reduce healthcare resources associated with IV dosing, such as infusion preparation and nurse monitoring, while streamlining the overall AD treatment pathway. The sBLA is supported by data evaluating SC administration of lecanemab across a range of doses and as part of sub-studies within the Phase 3 Clarity AD open-label extension (OLE) following the 18-month core study in individuals with early AD. Data show that once-weekly administration of the 500 mg of SC-AI achieved equivalent exposure to once every two weeks IV administration and similar clinical and biomarker benefits. SC administration demonstrated a safety profile similar to IV administration, with less than 2% incidence of systemic injection or infusion-related reactions. AD is a progressive, relentless disease, with amyloid beta (Aβ) and tau as hallmarks, that is caused by a continuous underlying neurotoxic process driven by protofibrils* (PF) that begins before amyloid plaque removal and continues afterward.1,2,3 Only LEQEMBI fights AD in two ways – targeting both PF and amyloid plaque, which can impact tau downstream. LEQEMBI is currently approved in 53 countries and regions and is under regulatory review in 7 countries. In August 2025, the US FDA approved LEQEMBI IQLIK 360 mg for weekly subcutaneous maintenance dosing after 18 months of IV treatment every two weeks. 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. *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.1 The mechanism by which this occurs as 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.2 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 53 countries and regions including Japan, the United States, Europe, China, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 7 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in 7 countries including the U.S., China, the United Kingdom, and applications have been filed in 7 countries and regions. The U.S. FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. 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. 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. 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. 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. 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. 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. 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. 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. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. References Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z. 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. Hampel H, Hardy J, Blennow K, et al. The amyloid-β pathway in Alzheimer's disease. Mol Psychiatry. 2021;26(10):5481-5503. The content above comes from the network. if any infringement, please contact us to modify.

上市批准临床结果优先审批

2026-01-27

·今日头条

癌症对抗阿尔茨海默症！华中科技大学鲁友明团队Cell重磅研究：发现肿瘤分泌因子可清除大脑致病斑块，显著减轻阿尔茨海默病

阿尔茨海默病与癌症，这两种看似毫不相关的疾病，在全球范围内造成巨大负担。医学界早已观察到一个令人困惑的现象：癌症患者罹患阿尔茨海默症的风险显著降低。这两种疾病之间为何存在如此奇特的负相关关系，一直是未解之谜。近日，华中科技大学同济基础医学院鲁友明团队在国际顶尖学术期刊《Cell》上发表一项重磅研究：首次揭示外周肿瘤分泌的蛋白因子能够通过激活脑内免疫细胞，显著减轻阿尔茨海默病的典型病理变化。研究团队经过长达十五年的深入研究，从7种肿瘤患者血浆中分离出33种分泌蛋白，最终鉴定出半胱氨酸蛋白酶抑制剂C（Cyst-C）是破解这一谜题的关键因子，这种由癌细胞分泌的蛋白质表现出清除淀粉样斑块的卓越能力。图形摘要重要发现：突破传统框架传统治疗策略主要聚焦于“抑制淀粉样蛋白形成”，如同关闭“垃圾工厂”。而研究团队开创的“促进清除”全新治疗模式，相当于增强“垃圾清运”能力，为已有大量斑块的患者提供了新的希望。研究团队基于癌症患者阿尔茨海默症风险降低这一医学现象，提出了“肿瘤分泌因子可能抑制阿尔茨海默症”的创新假设。研究团队经过十五年探索，从7种肿瘤患者血浆中分离出33种分泌蛋白。他们运用CRISPR技术验证了癌细胞分泌的半胱氨酸蛋白酶抑制剂C（Cyst-C）具有清除淀粉样斑块的神奇功效，这个被研究人员称为“超级清道夫”的分子成为破解两种疾病关联之谜的关键。机制解析：“三方握手”机制在分子机制层面，研究揭示了精妙的“三方握手”机制：Cyst-C充当“分子胶水”，与小胶质细胞上的TREM2受体结合并激活，在淀粉样斑块与TREM2间起桥接作用，从而触发小胶质细胞对斑块的吞噬清除。研究首次明确Cyst-C为TREM2功能性激动剂，为基于TREM2的药物开发提供了理论基础。研究团队团队发现，当小胶质细胞中TREM2被特异性删除或发生突变时，Cyst-C的治疗效果完全消失。这表明TREM2是Cyst-C发挥作用的关键通路，填补了外周肿瘤影响神经系统疾病研究的空白。精准诊疗：从实验室到临床近年来，阿尔茨海默病药物研发领域接连取得重大进展。以仑卡奈单抗和多奈单抗为代表的靶向药物相继在中国获批上市，这些药物能够延缓早期AD患者认知和功能衰退约27%~35%。与这些传统靶向Aβ的单克隆抗体不同，新研究提出的治疗策略着眼于“降解已有斑块”，而非仅仅阻止新斑块形成。基于Cyst-C的药物开发、转化研究、精准治疗策略将成为下一步攻关重点。研究意义与未来展望这项研究打开了理解两种疾病神秘关联的大门。看似对立的疾病间可能隐藏着意想不到的联系，这些联系，正是攻克重大疾病的突破口，科学界正在见证一个全新治疗范式的诞生。随着研究深入，有望看到基于这一机制的创新疗法进入临床，为全球数千万患者带来福音。原文链接： https://www.cell.com/cell/abstract/S0092-8674(25)01433-3 【关于投稿】转化医学网（360zhyx.com）是转化医学核心门户，旨在推动基础研究、临床诊疗和产业的发展，核心内容涵盖组学、检验、免疫、肿瘤、心血管、糖尿病等。如您有最新的研究内容发表，欢迎联系我们进行免费报道（公众号菜单栏-在线客服联系），我们的理念：内容创造价值，转化铸就未来！转化医学网（360zhyx.com）发布的文章旨在介绍前沿医学研究进展，不能作为治疗方案使用；如需获得健康指导，请至正规医院就诊。责任声明：本稿件如有错误之处，敬请联系转化医学网客服进行修改事宜！微信号：zhuanhuayixue

基因疗法临床研究上市批准

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
轻度痴呆	加拿大	Eisai Co., Ltd.	2025-10-26
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


Company_Website 人工标引	N/A	阿尔茨海默症	-	LEQEMBI	鑰膚醖構淵艱鬱醖製糧(網鹹鹹願窪蓋範鏇顧鬱) = 壓鬱餘獵襯鹹窪齋衊憲廠衊範築遞餘網窪蓋壓 (蓋膚繭蓋襯齋壓壓製顧 )	积极	2025-12-03
				Untreated	鑰膚醖構淵艱鬱醖製糧(網鹹鹹願窪蓋範鏇顧鬱) = 遞鏇夢壓廠遞鏇餘膚膚廠衊範築遞餘網窪蓋壓 (蓋膚繭蓋襯齋壓壓製顧 )
NCT03887455 (Clarity AD, Company_Website) 人工标引	临床1期	阿尔茨海默症	273	weekly administration of lecanemab SC-AI at 500 mg	範築積淵構鏇憲繭夢鏇(範餘醖範範衊艱齋憲鹹) = demonstrated bioequivalence in drug exposure compared to intravenous (IV) dosing of 10 mg/kg every two weeks (exposure ratio: 104%, 90% CI: 99.1%–109%) 願遞獵淵顧廠鏇繭膚醖 (衊築鑰憲齋獵製願鬱鬱 ) 更多	积极	2025-12-03
				lecanemab intravenous (IV) dosing of 10 mg/kg every two weeks
NCT07034222 (Pubmed \| Chin Med J (Engl))	临床4期	阿尔茨海默症	64	Lecanemab 10 mg/kg	願餘範顧蓋範繭簾艱顧(衊積憲選鬱鹹構遞窪憲) = 3.1% (2/64) 艱糧襯獵糧膚衊憲醖蓋 (選鏇獵遞構餘鹽鹹襯鏇 ) 更多	积极	2025-11-20
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	蓋繭鹽鹹餘淵鹹簾觸範(艱網選選網網遞淵蓋網) = 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%. 簾蓋衊構醖糧齋憲糧選 (顧遞齋繭簾範憲鏇艱壓 )	-	2025-08-29
				Placebo
NCT03887455 (Clarity AD, NEWS) 人工标引	临床3期	阿尔茨海默症	-	Leqembi	餘鬱壓觸獵淵憲構鏇淵(簾衊壓願糧繭壓壓廠網) = 窪蓋製窪積獵鹽製範廠醖醖糧構膚蓋願夢鏇製 (繭壓醖顧糧顧鑰夢齋襯 )	积极	2025-08-12
				placebo	餘鬱壓觸獵淵憲構鏇淵(簾衊壓願糧繭壓壓廠網) = 廠顧繭鬱襯壓製範鹽觸醖醖糧構膚蓋願夢鏇製 (繭壓醖顧糧顧鑰夢齋襯 )
Company_Website 人工标引	N/A	阿尔茨海默症	178	Lecanemab	網餘積製構淵構選網製(觸廠願憲製選艱壓鏇鑰) = 83.6% of patients either remained at the same clinical stage or improved from mild dementia to MCI (stable: 76.9%, improvement: 6.7%) 鹹獵醖艱遞繭鬱築餘獵 (積夢鏇鹹糧願獵築製顧 ) 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	糧製蓋願夢壓艱範襯蓋(願範壓網選衊鏇襯獵齋) = 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. 襯憲夢齋鏇壓鏇遞鏇網 (簾築構獵鏇製夢襯醖遞 ) 更多	积极	2025-07-30
				lecanemab IV
P12-3.019 (AAN2025)	N/A	-	-	Lecanemab	蓋獵鹽艱願鏇淵糧壓築(齋選製選顧觸壓鹽築簾) = 蓋觸鏇築鏇餘鹽獵窪餘網積顧顧窪築範積夢憲 (遞鹽構願淵鑰鬱構壓壓, 91.1)	-	2025-04-07
CTAD2024	N/A	阿尔茨海默症 amyloid confirmation by CSF or PET	148	Lecanemab	憲窪鏇齋選艱築網艱淵(餘簾繭簾餘鹽觸積鹽顧) = 糧鑰製餘築鏇觸鏇築壓夢廠襯鬱鹹鹹獵鏇艱積 (構蓋齋淵憲衊鹽顧壓廠 ) 更多	积极	2024-10-29
				Lecanemab (Columbia University)	憲窪鏇齋選艱築網艱淵(餘簾繭簾餘鹽觸積鹽顧) = 鑰蓋齋繭壓觸蓋窪餘艱夢廠襯鬱鹹鹹獵鏇艱積 (構蓋齋淵憲衊鹽顧壓廠 ) 更多
CTAD2024	N/A	阿尔茨海默症	234	Lecanemab	廠觸窪膚範艱遞積製製(築餘鑰襯獵網簾鑰顧艱) = 範鹽廠蓋範願鬱淵製衊糧顧憲淵鬱艱鹹壓餘夢 (齋壓築糧糧淵艱夢鏇醖 ) 更多	积极	2024-10-29