Assessment of Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for the Treatment of Patients With With Mild Cognitive Impairment (MCI) or Mild Alzheimer's Disease (AD) Undergoing Standard of Care Monoclonal Antibody (mAb) Therapy

The purpose of this study is to assess the safety and feasibility of administering standard of care monoclonal antibody (mAb) infusion therapy in combination with opening the blood-brain barrier with the Exablate Model 4000 Type 2 device in patients with mild Alzheimer's disease (AD) or mild cognitive impairment (MCI).

开始日期2022-07-14

申办/合作机构

West Virginia University

[+1]

NCT05310071

/ Terminated临床3期

A Phase 3b/4 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Verify the Clinical Benefit of Aducanumab (BIIB037) in Participants With Alzheimer's Disease

The primary objective of this study is to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score as compared with placebo in participants with early Alzheimer's disease.

开始日期2022-06-02

申办/合作机构

Biogen, Inc.

100 项与阿杜卡尼单抗相关的临床结果

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100 项与阿杜卡尼单抗相关的转化医学

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100 项与阿杜卡尼单抗相关的专利（医药）

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项与阿杜卡尼单抗相关的文献（医药）

2025-03-01·Interdisciplinary Sciences-Computational Life Sciences

ABTrans: A Transformer-based Model for Predicting Interaction between Anti-Aβ Antibodies and Peptides

Article

作者: Zeng, Xincheng ; Su, Yuhong ; Zhang, Lingfeng ; Bian, Yanlin ; Wang, Yangjing ; Ma, Buyong

Antibodies against Aβ peptide have been recently approved to treat Alzheimer's disease, underscoring the importance of understanding their interactions for developing more potent treatments. Here we investigated the interaction between anti-Aβ antibodies and various peptides using a deep learning model. Our model, ABTrans, was trained on dodecapeptide sequences from phage display experiments and known anti-Aβ antibody sequences sourced from public sources. It classified the binding ability between anti-Aβ antibodies and dodecapeptides into four levels: not binding, weak binding, medium binding, and strong binding, achieving an accuracy of 0.83. Using ABTrans, we examined the cross-reaction of anti-Aβ antibodies with other human amyloidogenic proteins, revealing that Aducanumab and Donanemab exhibited the least cross-reactivity. Additionally, we systematically screened interactions between eleven selected anti-Aβ antibodies and all human proteins to identify potential off-target candidates.

2025-01-01·JPAD-Journal of Prevention of Alzheimers Disease

Key considerations for combination therapy in Alzheimer's clinical trials: Perspectives from an expert advisory board convened by the Alzheimer's drug discovery foundation

Article

作者: Grundman, Michael ; Landen, Jaren ; Fillit, Howard ; Burstein, Aaron ; Partrick, Katherine ; Mintun, Mark ; Berry, Donald ; Kivipelto, Miia ; Cummings, Jeffrey ; Sampaio, Cristina ; von Eschenbach, Andrew ; Hendrix, Suzanne ; Irizarry, Michael ; Gold, Michael ; Green, Allan ; Sink, Kaycee ; Nisenbaum, Laura ; Arnold, Steven E

There is growing consensus in the Alzheimer's community that combination therapy will be needed to maximize therapeutic benefits through the course of the disease. However, combination therapy raises complex questions and decisions for study sponsors, from preclinical research through clinical trial design to regulatory, statistical, and operational considerations. In January 2024, the Alzheimer's Drug Discovery Foundation convened an expert advisory board to discuss the key considerations in each of these areas. Experts agreed on the need to prioritize a combination therapy approach that encompasses a wide range of targets associated with aging and the underlying biology of Alzheimer's disease. Progress in combination therapy could be accelerated by leveraging preclinical research and Phase 1 and 2A trials to identify the most promising combinations for further development, exploring repurposed agents with available preclinical and clinical data, building collaborations across sectors to support operational challenges, and planning for the likely impact of anti-amyloid beta-protein monoclonal antibody therapies on future clinical trial designs.

2025-01-01·JOURNAL OF NEUROLOGY

Brain MRI volumetry and atrophy rating scales as predictors of amyloid status and eligibility for anti-amyloid treatment in a real-world memory clinic setting

Article

作者: Hagman, G ; Rosenberg, A ; Mohanty, R ; Kivipelto, M ; Matton, A ; Lötjönen, J ; Westman, E ; Granberg, T ; Zilioli, A

Abstract:

Predicting amyloid status is crucial in light of upcoming disease-modifying therapies and the need to identify treatment-eligible patients with Alzheimer’s disease. In our study, we aimed to predict CSF-amyloid status and eligibility for anti-amyloid treatment in a memory clinic by (I) comparing the performance of visual/automated rating scales and MRI volumetric analysis and (II) combining MRI volumetric data with neuropsychological tests and APOE4 status. Two hundred ninety patients underwent a comprehensive assessment. The cNeuro cMRI software (Combinostics Oy) provided automated computed rating scales and volumetric analysis. Amyloid status was determined using data-driven CSF biomarker cutoffs (Aβ42/Aβ40 ratio), and eligibility for anti-Aβ treatment was assessed according to recent recommendations published after the FDA approval of the anti-Aβ drug aducanumab. The automated rating scales and volumetric analysis demonstrated higher performance compared to visual assessment in predicting Aβ status, especially for parietal-GCA (AUC = 0.70), MTA (AUC = 0.66) scores, hippocampal (AUC = 0.68), and angular gyrus (AUC = 0.69) volumes, despite low global accuracy. When we combined hippocampal and angular gyrus volumes with RAVLT immediate recall and APOE4 status, we achieved the highest accuracy (AUC = 0.82), which remained high even in predicting anti-Aβ treatment eligibility (AUC = 0.81). Our study suggests that automated analysis of atrophy rating scales and brain volumetry outperforms operator-dependent visual rating scales. When combined with neuropsychological and genetic information, this computerized approach may play a crucial role not only in a research context but also in a real-world memory clinic. This integration results in a high level of accuracy for predicting amyloid-CSF status and anti-Aβ treatment eligibility.

988

项与阿杜卡尼单抗相关的新闻（医药）

2025-02-20

·PRNewswire

The Alzheimer's Drug Discovery Foundation Announces Daniel M. Skovronsky, MD, PhD, of Eli Lilly & Company, as Recipient of Prestigious 2025 Melvin R. Goodes Prize

Skovronsky will be recognized for his extraordinary work with the Amyvid PET scan, the first FDA-approved diagnostic test for Alzheimer's.The Goodes Prize – referred to the Nobel Prize of Alzheimer's research – honors scientists making extraordinary and lasting contributions to the Alzheimer's field. NEW YORK, Feb. 20, 2025 /PRNewswire/ -- The Alzheimer's Drug Discovery Foundation (ADDF) will present its 2025 Melvin R. Goodes Prize to Daniel M. Skovronsky, MD, PhD, Chief Scientific Officer, Lilly, and President, Lilly Research Labs, at the Inaugural ADDF Scientific Summit on Wednesday, March 5th. Skovronsky will be recognized for his groundbreaking work to develop critical diagnostic tests for Alzheimer's in addition to his leadership in developing and commercializing Kisunla, one of the first disease-modifying therapies for Alzheimer's patients. Continue Reading Daniel M. Skovronsky, MD, PhD, of Eli Lilly & Company, announced as the 2025 Melvin R. Goodes Prize The game-changing diagnostics developed with Skovronsky's help include the Amyvid PET scan, the first FDA-approved diagnostic test for Alzheimer's; the Tauvid PET scan, the first and only FDA-approved diagnostic for Tau in the brain; and a blood biomarker test for p-tau217 for the early diagnosis of Alzheimer's disease. The Goodes Prize, referred to as the Nobel Prize of Alzheimer's research, is presented annually to a leading scientist to mark exceptional contributions to the Alzheimer's field. This international award was established by the late Melvin R. Goodes to advance critical science aimed at fighting Alzheimer's disease and related dementias. "Dan is the epitome of a Goodes Prize awardee, a leading scientist who has advanced innovative and bold ideas to transform how we diagnose and develop new treatments for Alzheimer's," said Howard Fillit, MD, Co-Founder and Chief Science Officer at the ADDF. "The Goodes Prize emphasizes our ongoing commitment to accelerating drug development for Alzheimer's and honors the legacy of Mel Goodes, a trailblazer in the pharmaceutical industry. We are thrilled to recognize Dan's outstanding work and partnership with the ADDF, which spans more than 20 years. His efforts to develop the Amyvid PET scan made recent Alzheimer's drug approvals possible, including Lilly's Kisunla, and will benefit patients now and for years to come." The Amyvid PET scan, which received early seed funding from the ADDF, is a brain imaging test that helps detect Alzheimer's disease by combining a positron emission tomography (PET) scan and an injection of Amyvid, a radioactive tracer. Amyvid was instrumental in the approval of the first disease-modifying Alzheimer's drugs – Aduhelm in 2021, Leqembi in 2023, and Kisunla in 2024 – providing the biomarker data needed for regulatory approval. "Over the past decade, we have witnessed remarkable advances in Alzheimer's research," said Dr. Daniel Skovronsky, Chief Scientific Officer, Lilly, and President, Lilly Research Labs. "It is my belief that through early detection and early intervention we can someday make Alzheimer's a preventable disease. I am deeply honored to receive the prestigious Goodes Prize award and look forward to joining fellow recipients who are leading the way in developing new treatments for Alzheimer's. The early support from the ADDF for my work, which aimed to revolutionize how we diagnose patients to ensure the right ones were included in our studies, was crucial to advancing the field, and I will always be grateful for that support." The Goodes Prize, which celebrated its 10th anniversary last year in Stockholm with a program featuring Queen Silvia of Sweden and U.S. Ambassador to Sweden Erik Ramanathan, honors scientists who are leading new approaches to developing Alzheimer's therapeutics and diagnostics. "To have pioneering scientists like Dan who have received this award out there in the field, pushing research forward, is truly a gift," said Nancy Goodes, ADDF Board Member. "The breakthroughs being made in the name of the Goodes Prize are the most meaningful legacy for my husband." The 11th annual Goodes Prize will be presented at 6:00 p.m. ET on Wednesday, March 5, 2025 during the inaugural ADDF Scientific Summit. This celebration of Alzheimer's science will be hosted by Dr. Howard Fillit and features a keynote address from Dr. Sanjay Gupta, MD, CNN Chief Medical Correspondent, bestselling author and practicing neurosurgeon. The summit will highlight nine world-renowned scientists and recipients of the Melvin R. Goodes Prize discussing therapeutics, biomarkers, prevention, and what is coming next in the field. Skovronsky will be the latest to join the ranks of these accomplished scientists who have helped bring the biology of aging to the forefront of Alzheimer's research. "The Goodes Prize represents our mission to treat, prevent, and ultimately cure Alzheimer's disease," commented Mark Roithmayr, ADDF Chief Executive Officer. "We support one of the largest and most diverse clinical development portfolios for Alzheimer's disease, and pioneering research, like Dan's, is critical to our goal of driving meaningful innovation and change in drug development." The Melvin R. Goodes Prize for Excellence in Drug Development was established in 2015 in honor of Melvin R. Goodes, former CEO of Warner-Lambert Company, who channeled his unique knowledge of the drug industry into Alzheimer's advocacy after being diagnosed with the disease. The award recognizes individual researchers whose work has significantly advanced our understanding of Alzheimer's, paving the way for potential breakthroughs in treatment and prevention. Previous Goodes Prize recipients have demonstrated tremendous innovation and perseverance in the quest for effective treatment options for Alzheimer's. Internationally lauded as the highest recognition in Alzheimer's research, the Goodes Prize has helped move the field forward by facilitating thought provoking discussions among leading scientists from academia, industry, and philanthropy in pursuit of a future free of Alzheimer's. About The Alzheimer's Drug Discovery Foundation (ADDF) Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF's leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer's PET scan (Amyvid®) and blood test (PrecivityAD®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $370 million to fund 765 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 21 countries. To learn more, please visit: . SOURCE Alzheimer's Drug Discovery Foundation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2025-02-20

·抗体圈

单克隆抗体：治疗阿尔茨海默病的关键？

科学家在治疗阿尔茨海默病方面取得了重大进展，单克隆抗体作为一种重要手段，有望阻止病情发展并缓解症状。阿尔茨海默病是由淀粉样蛋白和 tau 蛋白异常大量积累形成斑块所致。随着时间推移，这些纠结的结构会损害神经细胞，尤其是大脑中控制记忆的细胞。据阿尔茨海默病协会统计，美国近 700 万人患有阿尔茨海默病。虽然 73% 的患者年龄在 75 岁及以上，但年轻的高风险成年人群体也在不断扩大，这主要是由罕见的基因突变引起的，有时这些突变会代代相传。美国华盛顿大学医学院（WashU Medicine）牵头的一项新试验正在研究一种单克隆抗体，有望在阿尔茨海默病发病前几十年就阻止其发展。 1.单克隆抗体 remternetug 能否预防阿尔茨海默病？单克隆抗体是一种能与体内特定靶点结合的蛋白质。在治疗阿尔茨海默病时，其靶点是大脑中的淀粉样 β 蛋白聚集体。通常，单克隆抗体与这些聚集体结合后，会触发大脑中的免疫细胞（小胶质细胞）清除这些有害蛋白质，从而减缓认知能力下降。华盛顿大学医学院与制药巨头礼来公司密切合作，正在评估单克隆抗体 remternetug 预防阿尔茨海默病的效果。它旨在清除大脑中的淀粉样 β 蛋白，甚至阻止其积累。研究人员希望，在疾病早期，人们还未出现症状时，通过清除低水平的淀粉样 β 蛋白斑块或阻止其积累，能在最早阶段阻断疾病发展，让人们免于出现症状。 “在过去几年里，我们在阿尔茨海默病治疗方面取得了巨大进展。” 该试验的首席研究员、神经病学教授埃里克・麦克戴德在上周的新闻发布会上表示，“两种针对淀粉样蛋白的药物已被证明可以减缓疾病症状，目前已获得美国食品药品监督管理局（FDA）批准，用于治疗因阿尔茨海默病导致的轻度认知障碍或轻度痴呆患者。这有力地支持了我们的假设，即在淀粉样 β 蛋白斑块出现的最早阶段，症状出现之前进行干预，有可能从一开始就预防症状的出现。” 这项研究正在招募年龄在 18 至 25 岁之间、大脑中蛋白质水平几乎没有阿尔茨海默病相关变化的人，也就是在预计痴呆症状出现之前。目前，该试验仅限于有基因突变、有患阿尔茨海默病风险的人，但研究人员希望该研究结果能为未来治疗各种形式的阿尔茨海默病提供参考。该试验已投入超过 1.3 亿美元，资金来自美国国立卫生研究院（NIH）下属的国家老龄化研究所（NIA）、阿尔茨海默病协会和 GHR 基金会的资助。 “这是一种开创性的方法。”GHR 基金会的首席运营官弗雷德・米勒表示，“我们首次致力于在阿尔茨海默病病理形成之前就预防其积累。这项研究将为我们如何为这些家庭，以及预计到 2050 年美国近 1300 万阿尔茨海默病患者和全球无数患者预防该病提供思路。”2.单克隆抗体：获批用于治疗阿尔茨海默病，但仍存在问题虽然 remternetug 的研究进展是一项重大突破，但单克隆抗体在治疗阿尔茨海默病的道路上并非一帆风顺。第一种在人体中测试治疗阿尔茨海默病的单克隆抗体是 bapineuzumab，它是从小鼠体内发现的抗淀粉样 β 抗体的人源化变体。为解决无法穿过血脑屏障（BBB）的问题，研究人员采用高剂量静脉注射，但这反而导致血脑屏障破裂和液体积聚（称为血管源性水肿），最终该药物于 2012 年宣告失败。不过，这并未阻止其他单克隆抗体进入临床试验。然而，尽管这些药物能有效减少淀粉样斑块，但仍无法减缓患者认知能力的下降，挫折不断。第一种获批用于治疗阿尔茨海默病的单克隆抗体也饱受争议。2021 年，FDA 批准了渤健（Biogen）的 aducanumab（商品名 Aduhelm），但去年该药物就停产了。有报道称，该药物的审批 “存在诸多违规之处”，尤其是它仅基于一项研究就获得批准。此外，脑肿胀和出血等安全风险令人担忧，而且其最初每年 5.6 万美元的价格让保险公司和患者都难以接受。因此，渤健及其合作伙伴日本制药公司卫材（Eisai）决定将资源重新集中在另一种单克隆抗体 Leqembi 上。2023 年，Leqembi 获得 FDA 批准。Leqembi 是一种人源化免疫球蛋白 γ1（IgG1）单克隆抗体，通过清除大脑中的淀粉样 β 蛋白发挥作用。它的获批基于 3 期试验数据，Leqembi 达到了主要终点和所有关键次要终点。与安慰剂相比，使用该药物治疗 18 个月后，患者认知能力下降幅度降低了 27%。此外，用于衡量患者独立生活能力的次要终点 —— 轻度认知障碍日常生活活动合作研究量表（ADCS MCI-ADL），经阿尔茨海默病患者护理人员评估，显示出 37% 的显著益处。除了渤健的药物，制药巨头礼来公司的 Kisunla（donanemab）去年 7 月也获得了 FDA 批准。在 18 个月的试验中，与安慰剂相比，它使患者认知能力下降幅度最多减缓 35%，比 Leqembi 略高，同时将患者疾病进展风险降低了 39%。和 Leqembi 一样，它也是一种 IgG1 单克隆抗体，通过清除大脑中的淀粉样 β 蛋白斑块发挥作用。3.临床中用于治疗阿尔茨海默病的单克隆抗体生物技术公司认为他们能取得更好的成果。罗氏（Roche）的临床候选药物 trontinemab 虽然也是单克隆抗体，但作用机制与 Leqembi 和 Kisunla 略有不同。它在通过血脑屏障方面更具优势，意味着较低剂量即可达到效果，这一点优于已获批的阿尔茨海默病单克隆抗体。它是借助罗氏的 Brain Shuttle 技术开发的，该技术通过连接一个 Fab 片段（抗体中含有抗原结合位点的部分），与附着在 IgG1 抗体效应域上的人转铁蛋白受体结合。在患者中检测到的脑肿胀和出血病例较少，这表明它在减轻副作用和治疗阿尔茨海默病方面可能更具潜力。最新试验显示，在 12 至 28 周后，两个较高剂量组（1.8mg/kg 和 3.6mg/kg）使用该候选药物后，淀粉样蛋白斑块迅速且大量地被清除。然而，一名患者的死亡引发了试验方案的改变。一名 78 岁的患者因脑出血去世，现在，患有浅表性铁沉积症（一种会导致脑出血的罕见疾病）的参与者已被排除在试验之外。 “利用主动转运机制使这些药物穿过血脑屏障，将极大地加快淀粉样蛋白的清除速度，同样重要的是，能真正降低淀粉样蛋白相关影像学异常（ARIA）的发生率。” 神经科顾问凯瑟琳・穆默里在去年 11 月于西班牙举行的阿尔茨海默病临床试验会议上表示，她还补充说 trontinemab 的进展 “非常令人兴奋”。与此同时，美国 Acumen Pharmaceuticals 公司的 sabirnetug 正在进行 2 期试验，目前正在招募患者。它是第一种在临床上证明能靶向淀粉样 β 寡聚体（具有毒性的淀粉样 β 蛋白簇）的人源化单克隆抗体。该候选药物成功降低了大脑中脑脊液（CSF）生物标志物的水平，脑脊液生物标志物可通过检测其中蛋白质水平的变化来帮助诊断阿尔茨海默病。4.克服安全问题当前的试验不仅致力于提高单克隆抗体的疗效，改善其安全性也至关重要。如前所述，这类药物因其带来的健康风险而备受批评。美国家庭医生学会的一项分析表明，单克隆抗体治疗阿尔茨海默病的风险可能大于益处，其中最严重的风险是淀粉样蛋白相关影像学异常（ARIA）。在试验中还观察到了一些出血情况，如脑微出血和含铁血黄素沉着症。优化剂量是提高这些药物安全性的一种方法。目前，Leqembi 的推荐剂量是 10mg/kg，但像 trontinemab 这样更容易穿过血脑屏障的新型单克隆抗体，或许能改变给药剂量，将副作用降至最低。另一个需要注意的因素是患者的其他基础疾病。因此，根据风险因素仔细筛选患者十分重要。例如，trontinemab 试验排除了患有浅表性铁沉积症的参与者，有助于避免易出血患者出现并发症。但《神经病学》杂志发表的一项研究显示，这使得只有一小部分早期疾病患者有资格接受单克隆抗体药物治疗。 “虽然这些新的阿尔茨海默病疗法有望减缓许多患者的病情发展，但事实是这些药物仅在患有最早期疾病的人群中进行过研究。” 该研究的作者、美国神经病学学会成员玛丽亚・瓦西拉基在 2023 年的新闻发布会上表示，“导致 FDA 加速批准这些疗法的临床试验的纳入和排除标准，是决定患者是否适合接受这些药物治疗的依据。我们的研究估计，只有一小部分因阿尔茨海默病导致早期认知障碍的老年人可能有资格接受针对大脑淀粉样 β 蛋白的单克隆抗体治疗。” 也许像 trontinemab 这样的候选药物能改变现状，因为它已被证明更容易穿过血脑屏障，较低的剂量可能会让更多患者参与药物试验。此外，如果能借助 remternetug 等药物将疾病扼杀在萌芽状态，未来受阿尔茨海默病影响的人数可能会减少，治疗也可以更多地集中在晚期阿尔茨海默病上，而这一领域目前在治疗方面进展甚微。原文参考：Monoclonal antibodies: A potential game-changer for Alzheimer’s 识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

临床结果临床研究

2025-02-17

·抗体圈

渤健砍掉四条神经管线，未来聚焦何处？

近日，渤健（Biogen）在 2024 年财报中宣布将停止 4 款中枢神经系统药物的开发工作，这一决定在生物医药领域引起了广泛关注。作为神经疾病药物研发的龙头企业，渤健的这一举措背后究竟有着怎样的考量？本文将结合相关报道和财报信息，为您详细解读。一、被砍掉的四条管线 BIIB113 ：这是一款口服小分子 TAU 聚集抑制剂，原本正在进行针对阿尔茨海默病的 1 期临床。2024 年 1 月，渤健宣布放弃 Aduhelm 时，曾将 BIIB113 列为值得关注的优先项目，如今却难逃被砍命运。 BIIB094 ：靶向富亮氨酸重复激酶 2（LRRK2）的反义寡核苷酸药物，用于治疗帕金森病，目前处于 1 期临床研究阶段。 BIIB101 ：靶向 α- 突触核蛋白（α-synuclein）的反义寡核苷酸药物，用于治疗多系统萎缩，已进入 1 期临床阶段。 BIIB143（cemdomespib）：热休克蛋白 90（Hsp90）调节剂，用于糖尿病周围神经性疼痛的治疗，正在开展 II 期临床。该药物由渤健于 2023 年收购 Reata Pharmaceuticals 而获得，是本次被终止管线中研发进度最快的。二、业绩疲软与研发战略调整近年来，渤健的业绩表现不尽如人意，创新乏力、业绩下滑导致其股价持续下跌，全球制药巨头排名也从 2020 年的第 20 位下降至如今的第 25 位。2024 年财报显示，全年营收 96.76 亿美元，同比下降 2%，其中产品收入 72.14 亿美元。产品收入下降主要受多发性硬化症业务收入下跌的驱动，同时，寄予厚望的 AD 新药市场表现也不及预期，Aduhelm 失败后，Leqembi 销售缓慢，2024 年收入 8700 万美元，虽较 2023 年的 1000 万美元有大幅上涨，但距行业预期仍有较大差距。在这样的背景下，渤健决定砍掉上述四条管线，将研发资源集中于少数几个临床阶段的项目，这些项目被认为具有较高的确定性，能够定期提供关键研究成果，并有可能实现产品市场推出。在 2024 年财报 PPT 中，渤健展示了现阶段开发确定性高的管线项目，包括 4 个 I 期项目、6 个 II 期项目、5 个 III 期项目和 3 个注册中项目，神经系统疾病仍然是其主要业务，重点包括 AD、SMA，此外还有几款自免管线，如 SLE 和 CLE。三、未来展望尽管渤健目前面临业绩压力和研发管线调整的挑战，但其在神经疾病领域的深厚积累和持续投入仍不容忽视。未来，渤健将聚焦于高确定性的研发项目，期待能够通过这些项目实现产品的成功上市，为患者带来新的治疗选择，同时也为公司创造新的增长点。对于生物医药行业的从业者和投资者来说，渤健的这一战略调整无疑是一个值得关注的重要信号。识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

财报临床2期临床1期并购临床3期

100 项与阿杜卡尼单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10541	阿杜卡尼单抗	N07	DB12274

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
阿尔茨海默症	美国	Biogen, Inc.	2021-06-07

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2期	美国	Biogen, Inc.	2018-12-20

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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


NEWS 人工标引	N/A	阿尔茨海默症	3	聚焦超声+aducanumab	糧淵鑰鏇觸醖製窪淵齋(廠餘憲艱醖淵醖夢廠製) = 6个月的联合治疗阶段，所有聚焦超声靶向脑区的血脑屏障均有开放，在手术后24-48小时内关闭，齋壓簾願衊鑰膚簾餘顧 (窪壓築艱憲艱鏇鹹選獵 ) 更多	积极	2024-01-04
				aducanumab (对侧未接受聚焦超声)
TRAILBLAZER-ALZ-4 (AAN2023)	临床3期	阿尔茨海默症	148	Donanemab	餘襯積製齋膚簾製餘鏇(鏇艱夢艱窪積選壓艱餘) = 62.0% of donanemab-treated and 66.7% of aducanumab-treated participants reported an adverse event (AE), there were no serious AEs due to ARIA in donanemab arm and 1.4% serious AEs (one event) due to ARIA were reported in aducanumab arm. 艱襯壓繭鑰廠繭鹽壓積 (網夢遞製醖艱鹽憲憲簾 )	-	2023-04-25
				Aducanumab
NCT02477800 (ENGAGE, AAIC2022)	临床3期	阿尔茨海默症 ApoE3/3 \| ApoE4/4	-	Aducanumab (Patient 1)	蓋觸鑰淵網憲憲願遞築(膚網選襯遞廠齋夢憲憲) = 遞衊築積齋鬱積遞壓範網壓膚鏇壓糧窪艱繭鹹 (顧窪繭鹹願築夢鑰膚觸 )	-	2022-12-20
				Aducanumab (Patient 2)	蓋觸鑰淵網憲憲願遞築(膚網選襯遞廠齋夢憲憲) = 築憲鏇衊憲醖簾淵構餘網壓膚鏇壓糧窪艱繭鹹 (顧窪繭鹹願築夢鑰膚觸 )
NCT02484547 \| NCT02477800 (EMERGE and ENGAGE, AAN2022)	临床3期	apolipoprotein ɛ4	2,192	Aducanumab 10 mg/kg	鹹衊窪獵選鏇製鬱襯鬱(餘構築壓衊糧夢築鏇鏇) = 遞遞夢齋壓膚築齋餘淵夢獵淵觸繭構積鑰襯壓 (簾壓淵壓鹹淵鹹繭淵衊 ) 更多	积极	2022-05-03
				Placebo	膚鏇鑰蓋築膚製廠鹽襯(膚築繭遞壓齋鬱構網願) = 蓋壓積鏇鹹積窪鹹壓顧積醖觸醖蓋襯膚衊餘積 (製鑰鬱鹽積網網顧餘鬱 )
EMERGE and ENGAGE (AAIC2021)	N/A	apolipoprotein ε4	3,285	Aducanumab	窪廠膚夢選網醖廠齋願(蓋顧淵夢廠網蓋鹽糧顧) = 觸築網範齋窪膚夢窪憲範顧鹽夢築繭襯鹽窪鬱 (構獵獵夢網壓襯選齋鬱 ) 更多	-	2021-12-31
NCT03639987 (EVOLVE, CTgov)	临床2期	阿尔茨海默症 \| 认知功能障碍	52	Placebo+Aducanumab (Group 1)	構齋繭獵願積窪築齋積(襯築淵鹽願衊構願願遞) = 鏇襯膚網構簾顧膚鑰夢淵簾艱齋餘顧遞餘憲鑰 (簾構壓製廠憲餘齋鹽製, 鏇淵壓積鑰鬱膚築觸夢 ~ 夢醖蓋廠鏇鹹糧簾鹽願) 更多	-	2021-09-16
				Aducanumab (Group 2)	構齋繭獵願積窪築齋積(襯築淵鹽願衊構願願遞) = 鏇鏇淵糧鏇夢憲網願壓淵簾艱齋餘顧遞餘憲鑰 (簾構壓製廠憲餘齋鹽製, 衊夢鹹選艱淵願鑰糧獵 ~ 簾襯獵醖遞淵鏇選窪網) 更多
NCT02477800 (221AD301 \| ENGAGE, CTgov)	临床3期	阿尔茨海默症	1,653	Placebo (Placebo (PC Period))	鑰醖鏇蓋簾窪範鑰繭襯(鹹製顧鹽選齋觸壓壓範) = 獵範窪鏇鑰簾蓋構夢製製艱窪鹽簾鬱蓋鑰鏇鹹 (蓋襯艱窪觸遞鬱積夢願, 構憲簾選廠觸襯積餘築 ~ 製鬱選夢積廠齋餘選齋) 更多	-	2021-09-02
				BIIB037 (BIIB037 Low Dose (PC Period))	鑰醖鏇蓋簾窪範鑰繭襯(鹹製顧鹽選齋觸壓壓範) = 壓蓋醖製鏇餘蓋衊壓廠製艱窪鹽簾鬱蓋鑰鏇鹹 (蓋襯艱窪觸遞鬱積夢願, 蓋膚鏇餘廠醖觸積蓋鏇 ~ 鹹鬱鏇鑰衊鹽餘遞鹽鬱) 更多
NCT02484547 (221AD302 \| EMERGE, CTgov)	临床3期	阿尔茨海默症	1,643	Placebo (Placebo (PC Period))	簾獵夢窪願壓遞艱艱糧(願餘衊齋觸壓獵積窪齋) = 願餘壓衊範製淵鑰鏇範壓蓋網壓獵鏇簾顧觸遞 (顧醖構艱窪醖鹹蓋廠艱, 醖淵願選壓獵夢顧簾遞 ~ 艱鬱製襯夢蓋鹹鬱觸齋) 更多	-	2021-09-02
				BIIB037 (BIIB037 Low Dose (PC Period))	簾獵夢窪願壓遞艱艱糧(願餘衊齋觸壓獵積窪齋) = 鹽繭鬱蓋糧遞積鹹艱鑰壓蓋網壓獵鏇簾顧觸遞 (顧醖構艱窪醖鹹蓋廠艱, 簾鹽獵繭鹽蓋鹹艱衊構 ~ 觸蓋鑰遞壓願鏇簾網膚) 更多
NCT02484547 (EMERGE, PipelineReview) 人工标引	临床3期	阿尔茨海默症	-	aducanumab	廠獵繭遞願膚鹹窪鏇製(觸衊構築壓選艱網餘鏇) = Independent data monitoring committee advises aducanumab unlikely to meet primary endpoints, leading to decision to discontinue the trials.The recommendation to stop the studies was not based on safety concerns. 壓夢願選獵繭遞衊遞淵 (鏇範網餘廠壓淵膚蓋憲 )	不佳	2019-03-21
				Placebo
NCT01677572 (PRIME, AAN2017)	临床1期	阿尔茨海默症 ApoE ɛ4	196	Aducanumab fixed doses	襯襯鬱鏇鏇願製範襯衊(壓獵糧衊淵鑰膚襯網壓) = 衊鑰顧構衊築繭築繭壓襯艱艱鹽遞鹽憲鏇獵選 (衊窪鏇鏇鑰醖夢淵膚鹽 )	积极	2017-04-18