A Randomized, Double-Blind, Placebo-Controlled, Phase 4 Dose-Escalation Study Evaluating the Safety, Tolerability, and Efficacy of Donanemab in Adults With Down Syndrome

The goal of this clinical trial is to learn if donanemab can reduce levels of amyloid in the brain, and if donanemab is safe and well-tolerated in participants with Down syndrome.
The main questions it aims to answer are: Does donanemab reduce amyloid in the brain? Is donanemab safe and well-tolerated in people with Down syndrome? Researchers will compare donanemab to a placebo (a look-alike substance that contains no drug) to see if donanemab works to reduce levels of amyloid in the brain.
Participants in the study will be 35-50 years old and will be in the study for 12 months. Participants will then stay in the study for an additional 12 months in an long-term extension where all participants will receive donanemab. Participants who had a reduction in amyloid (measured by amyloid brain scan) by the end of the first 12 months will receive placebo for the long-term extension, while participants who did not have an amyloid reduction will receive study donanemab for the long-term extension. Everyone (participants and study staff) will remain blinded to treatment for the duration of the study.
Participants will:
* Have intravenous (IV) infusions of donanemab (or placebo) every 4 weeks
* Visit the clinic once every other month for checkups and tests. These tests will include brain scans (magnetic resonance imaging [MRI] and positron emission tomography [PET] ), blood draws and memory tests.
* Have a study partner who who can provide information about the participant and can join participant for some of the study visits.

开始日期2026-08-01

申办/合作机构

University of Southern California

[+3]

NCT07571161

/ Not yet recruiting临床3期

A Study of Donanemab Versus Placebo in Chinese Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease

The main purpose of this study is to evaluate the effects of donanemab (LY3002813) versus placebo in Chinese participants who are at risk for decline of memory, language and physical ability to perform activities of daily living from Alzheimer's disease (AD).
The study drug will be administered intravenously (IV) (into a vein in the arm).
The study will last up to approximately 156 weeks, excluding screening.

开始日期2026-04-01

申办/合作机构

Eli Lilly & Co.

NCT06996730

/ Not yet recruiting临床2/3期IIT

A Double-Blind, Placebo-Controlled, Double-Dummy Study of Donanemab and RG6289 in PSEN1 E280A Mutation Carriers, and in Non-Randomized, Placebo-Treated Non-Carriers From the Same Kindred, to Evaluate the Efficacy and Safety of Donanemab, RG6289, or the Combination of Donanemab and RG6289, in the Treatment of Autosomal-Dominant Alzheimer's Disease

The study will be conducted in 2 blinded parts (Part 1 and Part 2). In Part 1, study participants who are mutation carriers will receive active donanemab and non-mutation carriers will receive placebo-donanemab for up to 18 months (76 weeks), with a minimum treatment period of 9 months. Amyloid PET scans will be conducted at screening, 9, and 18 months in Part 1. Participants who are at or below 11 CL at screening or reach complete amyloid plaque clearance as measured by florbetapir F18 PET (defined as ≤11 CL) at 9 months will initiate Part 2. Participants who are ≤11 CL at screening may delay their entry into Part 2 for up to 6 months at the discretion of the Investigator. All remaining participants will start Part 2 after completing 18 months (76 weeks) in Part 1 independent of amyloid results. Non-carriers will receive placebo in both Parts 1 and 2.
In Part 2, study participants who are mutation carriers will be randomized 1:1:1:1 in a full factorial design to receive either RG6289 + placebo-donanemab (RG6289 alone group), donanemab + placebo-RG6289 (donanemab alone group), the combination of RG6289 and donanemab (combination group), or placebo-RG6289 and placebo-donanemab (placebo group). All non-carriers will be assigned to the placebo group. CDR-GS at the end of Part 1 and the amyloid level using the last completed amyloid PET scan in Part 1 will be used for stratification. All study participants will participate in a double-dummy design for the duration of Part 2 receiving both an intravenous (IV) infusion at the required interval for the donanemab or matching placebo as well as a daily oral treatment of RG6289 or matching placebo.
An exploratory outcome of Part 1 is a comparison of the amyloid clearance between this ADAD cohort and historical controls using propensity score matching. The primary outcome in Part 2 is change from the start of Part 2 through the end of Part 2 in brain amyloid load in PSEN1 E280A mutation carriers as measured by amyloid PET imaging. Other endpoints will include fluid and imaging biomarkers and measures of cognition and functioning. The maximum study duration for any individual participant will be 3 years, not including the screening or follow-up periods

开始日期2026-01-15

申办/合作机构

Banner Health

[+2]

100 项与多奈单抗相关的临床结果

登录后查看更多信息

100 项与多奈单抗相关的转化医学

登录后查看更多信息

100 项与多奈单抗相关的专利（医药）

登录后查看更多信息

333

项与多奈单抗相关的文献（医药）

2026-05-01·JPAD-Journal of Prevention of Alzheimers Disease

Donanemab therapy in Alzheimer’s disease with mild cognitive impairment: Convergent amyloid, tau, and plasma biomarker normalization with cognitive improvement

Letter

作者: Tang, Limoran ; Xu, Yun ; Zhao, Hui

2026-05-01·GENERAL HOSPITAL PSYCHIATRY

Implementation and service impact of anti-amyloid therapy in a psychiatry-led dementia care program: Real-world evidence from a Japanese regional dementia center

Article

作者: Ishihara, Hiroyuki ; Nakamura, Tetsu ; Otani, Kyohei ; Kawabe, Kana

BACKGROUND:

Amyloid-targeting antibody therapies for Alzheimer's disease require substantial diagnostic infrastructure including amyloid PET imaging, repeated MRI monitoring, and specialized clinical evaluation. In Japan, psychiatrists frequently lead dementia diagnosis and treatment in general hospitals through designated Regional Dementia Medical Centers; however, the real-world service impact of implementing these therapies in psychiatry-led dementia care remains poorly described.

METHODS:

We conducted a retrospective analysis of administrative and billing data from a Regional Dementia Medical Center at Kakogawa Central City Hospital, Japan. Data included amyloid PET imaging, anti-amyloid monoclonal antibody therapy (lecanemab and donanemab), and associated reimbursement and acquisition costs between May 2024 and January 2026. This study was conducted as part of institutional quality improvement activities.

RESULTS:

During the observation period, 72 amyloid PET examinations were performed. Results were amyloid-positive in 50 cases (69%) and negative in 22 cases (31%). Of 50 amyloid-positive patients, 38 (76%) initiated anti-amyloid therapy (lecanemab: 14; donanemab: 24), with 389 total treatment administrations. ARIA was detected in 8 treated patients (21%), all asymptomatic. MRI examinations for ARIA monitoring increased from 5 in FY2023 to 58 in FY2024 and 139 in FY2025. Total reimbursement amounted to 35.4 million yen for lecanemab and 25.7 million yen for donanemab. Drug acquisition costs represented approximately 97% of reimbursement, with margins averaging 3%. Outpatient revenue per visit increased 141% from 5560 yen in FY2022 to 13,401 yen in FY2025, despite stable visit volumes (FY2022: 11,203; FY2024: 10,223).

CONCLUSIONS:

Implementation of amyloid-targeting antibody therapy in psychiatry-led dementia care substantially increases service activity and hospital revenue streams but generates narrow financial margins due to high drug acquisition costs. All ARIA cases were asymptomatic, supporting the feasibility of systematic monitoring within a psychiatry-led model in this setting. These findings highlight important structural and economic considerations for the sustainability of these programs in general hospital psychiatry.

2026-05-01·AMERICAN JOURNAL OF NEURORADIOLOGY

β-Amyloid PET Signal Reduction in Prior ARIA-E Regions after Antiamyloid Therapy for Alzheimer Disease

Article

作者: Masdeu, Joseph C ; Schulz, Paul E ; Finn, Quentin ; Pascual, Belen

BACKGROUND AND PURPOSE:

The relationship between regional brain edema caused by antiamyloid monoclonal antibodies (ARIA-E) and the degree of regional beta-amyloid (Aβ) PET signal reduction is unknown. We aimed at determining this relationship.

MATERIALS AND METHODS:

In patients with moderate or severe ARIA-E, we quantified changes in Aβ PET signal before and after ARIA-E resolution, comparing regions affected by ARIA-E with unaffected regions.

RESULTS:

In 4 of 5 patients treated with lecanemab or donanemab and who had moderate or severe ARIA-E, Aβ PET signal decreased significantly more in regions that had been involved with ARIA-E.

CONCLUSIONS:

Greater regional Aβ PET signal reduction in areas involved by ARIA-E may reflect enhanced local Aβ clearance, reduced tracer binding site availability, impaired glymphatic flow from immune complex deposition, or other mechanisms. The finding of greater regional Aβ PET signal reduction in ARIA-E regions refines the characterization of ARIA-E and raises the possibility that its occurrence may have beneficial as well as adverse implications.

1,743

项与多奈单抗相关的新闻（医药）

2026-05-15

·东方财富网

药闻｜从“卖权益”到“拿权益” 复星为何“反向BD”阿尔兹海默病新药？——访复星陈启宇

新华财经上海5月15日电（记者杜康）近日，复星医药与韩国生物制药公司AriBio达成阿尔茨海默病（AD）口服新药AR1001全球独家选择权合作。不同于中国创新药过去将海外权益授权给跨国药企的“授权出海”模式，此次复星医药选择“逆向”拿下海外创新药核心管线在全球主要市场的商业化权益，试图补齐中国药企长期缺失的全球商业化能力。　　关于此次“反向BD”（商务拓展），复星国际联席CEO、复星医药董事陈启宇表示，过去中国药企更擅长研发和临床，但全球商业化始终是短板。“复星希望借AR1001项目，真正建立全球商业化体系。”　　从早期青蒿素抗疟药进入非洲市场，到自主研发创新药汉斯状在东南亚获批，再到此次瞄准美国、欧洲等核心市场，复星医药的国际化路径，正从产品出海走向全球市场运营能力建设。　　从“卖权益”到“拿权益” 补上全球商业化短板　　13日，复星医药与专注于神经退行性疾病领域的韩国生物制药公司AriBio宣布，就阿尔茨海默病创新药AR1001的开发、注册、生产和商业化等权益签署全球独家选择权协议。　　根据协议，复星医药将向AriBio支付6000万美元选择权费；选择行权后，还将支付至多1.8亿美元首付款及监管里程碑付款。当产品年销售额达到一定规模后，还将触发销售里程碑付款。　　此次合作是在双方此前已就AR1001中国（含港澳地区）及部分东南亚10国市场权益达成合作基础上的进一步升级。随着新协议落地，合作范围正式扩展至美国、欧洲、日本等全球核心市场。　　据悉，AR1001是一款小分子口服药物，通过高选择性抑制磷酸二酯酶-5（PDE-5）发挥作用，被视为具有潜在差异化竞争力的治疗方案。目前，该药全球多中心III期临床正在推进，已在美国、欧洲、中国、加拿大和韩国等地入组超1500例患者。　　“这个项目与过去中国创新药BD逻辑完全相反。”陈启宇表示，过去更多是中国药企将海外权益交给跨国药企，由后者主导全球临床与商业化；而这一次，复星医药选择主动接手全球主要市场商业化运营。　　在他看来，资金已不再是中国创新药出海的核心门槛，真正稀缺的是全球商业化能力。“随着自身实力的增强，许多优秀的中国药企在资金储备和经营性现金流上，已经完全能够负担得起全球临床试验的财务成本。资金已不再是出海的‘一票否决项’，真正的考验在于商业化能力——药企能否在全球市场真正实现一款产品的商业价值。”　　“全球市场最终看两件事：产品数据是否足够硬，以及销售体系是否足够强。”陈启宇说，复星选择以AR1001作为切入口，正是希望借此锻造全球商业化能力。　　押注阿尔茨海默病蓝海瞄准差异化突破　　对于复星医药而言，将全球商业化的重要一战放在阿尔茨海默病领域，并非偶然。　　“与竞争白热化的肿瘤、代谢类或自免赛道相比，阿尔茨海默病药物是一个刚刚兴起的庞大蓝海市场，竞争烈度相对较低。这为我们提供了先入市场的绝佳契机。”陈启宇表示，在一个蓝海市场，用一款具有高度差异化的产品去打开局面，在销售队伍建设、市场准入和客户获取上的难度会大幅降低。　　事实上，全球阿尔茨海默病的发病机理极其复杂，在过去几十年里，新药研发堪称“九死一生”。直到近两年，沉寂数十年的阿尔茨海默病新药研发才终于迎来破局。跨国巨头卫材（Eisai）与渤健（Biogen）联合开发的仑卡奈单抗，以及礼来开发的多奈单抗相继获得美国FDA等监管机构的完全批准上市。这两款突破性的药物均为静脉注射的单克隆抗体，其核心机制是通过清除大脑中沉积的淀粉样蛋白（Aβ）斑块来延缓早期患者的认知衰退，验证了长期以来的Aβ假说。　　尽管跨国巨头已率先实现商业化突破，在陈启宇看来，AR1001依然具备极强的差异化竞争优势。　　首先是剂型。目前已获批产品多为静脉注射单抗，而AR1001为口服药物。AD患者大部分是老年人，居家治疗是最普遍场景，口服药依从性更高。其次是作用机制差异。现有单抗药物主要围绕清除Aβ或Tau蛋白展开，而AR1001更侧重改善脑血流和神经元保护，试图覆盖更复杂的神经退行性病理过程。　　“这个领域远远谈不上产品之间的重叠和内卷。”陈启宇表示，目前全球AD市场仍处于早期发展阶段，产品之间更多是差异化探索，而非同质化竞争。　　此外，他提到，在神经退行性疾病领域，中国药企与全球顶尖药企的差距并不算大。依托大量高水平研究型医院和临床资源，中国药企在临床研究效率、数据积累以及成本控制方面具备优势。再叠加中国创新药的高效与更可负担的价格优势，正是复星医药角逐全球商业化的底气所在。　　破局需要“在不确定中提前下注”　　尽管AD领域近年迎来突破，但人类对这类神经退行性疾病的认知仍十分有限。　　陈启宇表示，相比肿瘤领域已经形成较成熟的精准治疗体系，AD等中枢神经系统疾病的病因机制仍高度复杂，行业整体仍处于探索早期。“过去几十年，全球大药企屡战屡败。近两年虽然看到曙光，但对疾病机理的理解仍远远不够。”他说。　　这也意味着，AD药物研发注定是一场长期投入。　　陈启宇透露，复星医药已将其视为未来10年至20年的长期布局。未来除小分子和抗体药物外，公司还将探索小核酸药物、细胞治疗等前沿技术路径，并加强与国内头部临床科研机构合作。　　陈启宇表示，在未知的疾病领域，药物方案的完善必然是一个不断迭代的过程，“从无从下手，到有药证明可行，再到发现不足并持续迭代改进，基础研究与临床验证必须同步推进。”他以肿瘤药的发展史作为类比：伴随基因组测序的完成，肿瘤治疗从粗放的化疗，进化到了精准诊断、靶向药、大分子药和细胞治疗不断细分迭代的精准时代，并催生了繁荣的产业生态。　　面对AD赛道巨大的未知与不确定性，陈启宇坦言，促成此次千万美元级别的“反向BD”并非一帆风顺。谈及与AriBio的牵手过程，陈启宇表示，由于疾病本身的复杂性，公司内部在2024年初讨论时也有过担忧与分歧。“但在未知且不确定的领域，最重要的是对创新技术进行动态的数据跟踪与科学分析。”　　在抢占全球优质管线时，中国企业该如何与跨国大药企同台竞技？陈启宇表示，许多跨国大药企在对接创新企业时往往倾向于等到更确定的数据出炉后再做决定。而复星医药的策略是“先走一步”，在更早的阶段建立连接。“提前出手当然有风险，”陈启宇总结道，“但在未知的创新蓝海里，如果不愿承担风险，就抓不住最好的破局机会。”（文章来源：新华财经）

2026-05-15

·BioSpace

Biogen’s Alzheimer’s results bolster tau theory—and Denali’s next gen candidate

iStock, ktsimage If Biogen has shown that tau can impact cognition, Denali’s technology—validated with an FDA approval in Hunter syndrome—could ensure the medicine gets where it needs to be for the greatest therapeutic impact, analysts said. Biogen has helped validate the tau theory of Alzheimer’s, though with many caveats, side notes and what-ifs still to be addressed. But the news of the big biotech’s success with BIIB080 has helped bolster an eager group of smaller companies like Denali Therapeutics, which just might have a therapy that can break through in the challenging neurodegenerative disease. The Phase 2 results for BIIB080, released yesterday , led to a spike for Denali’s shares. But the stock has returned to normal as of Friday, trading around $19.39 apiece. “Investor confidence in the tau hypothesis should rise, naturally boding well for DNL628,” Jefferies wrote on Thursday afternoon. Biogen showed that BIIB080, a tau-targeting agent, led to cognitive improvements and improved key biomarkers associated with Alzheimer’s. The therapy failed on the main goal of the study, dubbed CELIA, as it did not lead to a dose-dependent change in disease severity at 76 weeks. Nevertheless, Biogen is advancing into Phase 3, buoyed by other efficacy signals. Analysts and investors were also enthused by the data, with Jefferies seeing “sufficient [positive] cognitive trends” to support late-stage advancement. Alzheimer’s disease 4 Next-Gen Candidates That Could Form the Future of Alzheimer’s Treatment Following the hard-won success of early anti-amyloid drugs, a new generation of Alzheimer’s modalities—from tau-targeting gene silencers to blood-brain barrier delivery platforms—is entering the pipeline to anchor future combination therapies. January 19, 2026 · 7 min read · Ben Hargreaves Read more Biogen plans to release more details at the AAIC conference in July, which Jefferies believes could move Denali’s stock if positive. That’s because the biotech’s Transport Vehicle technology helps ease transfer of medicines across the blood-brain barrier. If Biogen has shown that tau can impact cognition, Denali’s technology—which has been validated with an FDA approval in Hunter syndrome—could ensure the medicine gets where it needs to be for the greatest therapeutic impact. Its DNL628, which uses the same technology and targets tau, is now in early clinical studies in patients with Alzheimer’s. “Taken together, BIIB080’s data clinically validates the intracellular tau approach partially de-risks DNL628 (also targets intracellular tau), and even potentially leaves room for ‘628 to differentiate on efficacy,” Jefferies wrote. Denali will reveal Phase 1b data for DNL628 in the first half of next year. The company is looking for a 40%–50% reduction in tau, according to Jefferies. As for cognitive impacts, the firm noted that the trial is relatively short at 24 weeks and therefore not powered to show such changes. If such effects emerge, however, it will be a major positive for Denali. Alzheimer’s disease I Remember Aduhelm. The Return of Roche in Alzheimer’s Is a Turning Point After covering the Alzheimer’s space through every high and low, BioSpace ’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance. December 2, 2025 · 2 min read · Annalee Armstrong Read more The biotech also has an edge because DNL628 is an intravenous injection, whereas Biogen’s BIIB080, now called diranersen, is delivered by intrathecal injection directly into the cerebrospinal fluid. Another biotech in the mix is Alector, which similarly has an anti-tau asset called AL164 that has readthrough to the Biogen data, according to William Blair. The siRNA therapy is still preclinical, with investigational new drug enabling studies getting underway. Like Denali, William Blair expects Alector to benefit from Biogen’s AAIC readout. Alector’s shares gained nearly 7% to close at $2.30 on Thursday. Denali is also developing an A-beta asset for Alzheimer’s, similar to approved Alzheimer’s therapies Biogen and Eisai’s Leqembi and Eli Lilly’s Kisunla. The Salt Lake City-based biotech will release Phase 1/2b data for DNL921 in 2027, which , if successful, will allow the drug to move directly into Phase 3, Jefferies noted. The next gen drug could be better than Leqembi and Kisunla given Denali’s blood-brain barrier technology, and even best Roche’s upcoming asset trontinemab, the analyst wrote. Roche’s Genentech unit showed in December last year that trontinemab cleared amyloid plaques in the brain, marking a return to the Alzheimer’s space for the Swiss pharma after a series of clinical failures saw Biogen and Lilly rise above.

临床2期

2026-05-14

·科学网

复星6000万美元押注阿尔茨海默症口服药

欢迎关注微信公众号“凤凰涅槃之路” 复星医药又一次加码阿尔茨海默症。这一次，它没有直接买断资产，而是选择了一种更谨慎、也更专业的交易结构：先支付 6000 万美元，获得 AriBio (韩国biotech)阿尔茨海默症三期口服药 AR1001 的全球期权；待 POLARIS-AD 三期顶线数据公布后，复星可再支付 8000 万美元行权，将权益扩展至美国、欧洲、日本等核心市场。对一个二期主要终点未达标、但仍在推进全球三期的 CNS 资产来说，这既是一张低于全面买断成本的“入场券”，也是一次高风险的战略卡位一、背景：阿尔茨海默病市场的致命诱惑与挑战阿尔茨海默病（Alzheimer’s Disease, AD）被誉为“研发黑洞”，全球有超过5000万患者，且随着老龄化加剧，这一数字正急剧攀升。尽管卫材/渤健的Leqembi以及礼来的Donanemab相继取得突破，但目前市场主流仍以注射用单克隆抗体为主。 AR1001的独特性： · 作用机制： AR1001是一种每日一次的口服磷酸二酯酶-5（PDE5）抑制剂。 · 科学逻辑：尽管PDE5抑制剂（如西地那非，俗称万艾可）最初用于勃起功能障碍，但临床前研究显示其具有显著的神经保护作用。 · 竞争优势：相比单抗药物昂贵的注射成本和淀粉样蛋白相关成像异常（ARIA）风险，口服药物具有极高的患者依从性和更低的医疗系统负担。二、资产发展脉络：从“失败”的二期到全球三期 AR1001的成名之路并非一帆风顺，其发展轨迹体现了典型的高风险生物医药研发特征： 1. 早期研发与二期挫折：在AriBio进行的Phase 2临床研究中，AR1001在第26周时未能达到改善阿尔茨海默病症状量表的主要疗效终点。 2. 转机出现：尽管临床量表表现平平，但研究人员发现AR1001在血浆生物标志物（与AD病理高度相关）方面表现出积极的有利变化。基于此，AriBio决定“豪赌”Phase 3。 3. 中国区的先行布局： 2024年，AriBio以约9000万美元的首付款将其中国区权益授权给了Neuco UnitedCo。随后，复星医药通过与该公司合作，先行锁定了中国市场的商业化权利。 4. 全球化版图扩张： 2026年5月，复星医药正式出手，直接与AriBio达成协议，意图将其控制权从中国扩展至美国、欧洲和日本等全球主流医药市场。三、并购详细信息：分阶段的“看涨期权”策略复星医药此次采取了极其专业的期权模式，而非一次性买断，以平衡高昂的风险与潜在的巨大收益。 1. 交易结构 · 预付款（Upfront）：复星支付6000万美元。这笔资金买断了复星在特定时间内行使许可权的优先权。 · 行权费（Option Fee）：若复星决定正式获得美国、欧洲、日本市场的授权，需支付额外8000万美元。 · 后续款项：包含未公开金额的开发里程碑、监管审批里程碑以及未来的销售分成。 2. 权益范围 · 地理覆盖：此次交易核心在于全球化，尤其是高定价、高壁垒的美、欧、日市场。 · 整合优势：结合此前已获得的中国区权益，复星医药已事实性地成为了AR1001未来全球商业化的核心主导者。四、深度分析：复星医药的战略图谋 1. 补齐AD版图的“救赎”之举复星在AD领域的布局此前曾遭遇重挫。2025年12月，复星曾斥资2亿美元收购绿谷制药（Green Valley）53%的股权，押注其海藻提取物药物（甘露特钠）。然而，绿谷制药随后陷入生产停滞，且未能及时更新到期许可证。此次重金押注AR1001，是复星在AD赛道重建信誉、寻找真正具有全球竞争力资产的战略修正。 2. 全球化战略的实质性跃迁郭广昌董事长强调，此举是复星医药“创新药国际化战略”的关键一步。 · 复星医药美国（Fosun Pharma USA）：复星自2017年建立美国子公司以来，一直在寻找能够支撑其商业化团队的“重磅炸弹”。AR1001的三期数据一旦成功，将直接助力复星在美国市场从“销售仿制药/小众药”向“经营创新药大单品”转型。 3. 风险对冲与节点把控目前AR1001的全球三期临床顶线数据预计将在2026年内公布。复星选择在此刻支付6000万美元期权费，而非等数据公布后再竞争，显示了其对该机制的信心，同时也通过“分期付款”的形式规避了三期完全失败带来的财务毁灭性风险。五、启示与展望 1. 差异化竞争是出路在礼来和卫材主导的Aβ（淀粉样蛋白）通路之外，复星选择PDE5抑制剂这一代谢/神经保护通路，避开了单抗药物的红海竞争。这种口服vs注射、神经保护vs蛋白清除的差异化思路，值得中国药企参考。 2. 全球权益的“碎片化整合” 复星的操作展示了如何通过多次交易、多轮谈判（先中国区、再全球期权）逐步吃下一个重磅品种。这种“蚕食式”并购降低了单次决策压力，有助于在不确定的环境中动态调整策略。 3. 二期失败不等于死刑 AR1001的案例提示研发型企业：临床终点的失败并不代表药物无效。深入挖掘生物标志物（Biomarkers）的数据，寻找科学上的合理解释，往往能让资产在三期临床中“起死回生”。总结复星医药对AR1001的6000万美元投入，是对阿尔茨海默病口服药物赛道的一次战略性卡位。在经历绿谷制药的挫折后，复星表现出了极强的韧性和对中枢神经系统领域的执着。2026年下半年的三期数据将是这场豪赌的“开奖时刻”——若成功，复星将一跃成为全球AD领域的重量级玩家；若失败，这也将成为创新药研发残酷性的又一注脚。

临床3期引进/卖出并购临床2期临床结果

100 项与多奈单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D11500	多奈单抗	-	-

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

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	Eli Lilly Nederland BV	2024-10-23
阿尔茨海默病引起的痴呆症	英国	Eli Lilly & Co.	2024-10-23
轻度认知障碍	英国	Eli Lilly Nederland BV	2024-10-23
轻度认知障碍	英国	Eli Lilly & Co.	2024-10-23
阿尔茨海默症	美国	Eli Lilly & Co.	2024-07-02

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
精神障碍	申请上市	加拿大	Eli Lilly Canada, Inc.	-
神经认知障碍	临床3期	中国	Eli Lilly & Co.	2022-10-10
神经认知障碍	临床3期	阿根廷	Eli Lilly & Co.	2022-10-10
神经认知障碍	临床3期	澳大利亚	Eli Lilly & Co.	2022-10-10
神经认知障碍	临床3期	波兰	Eli Lilly & Co.	2022-10-10
神经认知障碍	临床3期	韩国	Eli Lilly & Co.	2022-10-10
神经认知障碍	临床3期	西班牙	Eli Lilly & Co.	2022-10-10
神经认知障碍	临床3期	中国台湾	Eli Lilly & Co.	2022-10-10
神经认知障碍	临床3期	英国	Eli Lilly & Co.	2022-10-10
路易体病	临床2期	美国	Eli Lilly & Co.	2026-05-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05738486 (TRAILBLAZER-ALZ 6, CTgov)	临床3期	阿尔茨海默症 \| 神经认知障碍	1,175	Placebo+Donanemab (1400 mg Donanemab - Standard Regimen)	遞鏇鑰膚選鹽觸醖網餘 = 窪範淵衊鏇願繭鏇網製鑰糧願窪遞遞醖餘網鏇 (築製醖襯顧構壓鑰壓選, 淵蓋夢鬱蓋醖遞顧構選 ~ 遞夢選構窪築願夢淵衊) 更多	-	2025-11-14
				Placebo+Donanemab (1400 mg Donanemab - Dose Skipping)	遞鏇鑰膚選鹽觸醖網餘 = 製顧鏇艱壓膚蓋鹹夢願鑰糧願窪遞遞醖餘網鏇 (築製醖襯顧構壓鑰壓選, 網範壓糧獵鏇範築鏇願 ~ 衊壓衊製壓簾窪遞願齋) 更多
NCT05026866 (TRAILBLAZER-ALZ 3, Pubmed \| Alzheimers Dement)	临床1期	阿尔茨海默症	2,196	Donanemab (CDR‐GS: 0)	憲鑰糧鹹衊獵窪鬱獵製(淵廠壓襯膚糧憲餘夢願) = 鏇壓廠網簾遞夢膚衊簾鑰選積襯襯夢蓋夢夢遞 (顧鏇鏇鹹鏇廠繭製廠廠 ) 更多	积极	2025-09-01
				Donanemab (CDR‐GS: 0.5)	遞廠廠遞簾窪觸築鹹鹹(築糧網膚製鹽顧築構顧) = 鬱醖齋餘蓋願鹽膚膚襯積鑰襯鏇鏇積築憲齋繭 (廠鹽獵鏇鬱選顧選遞鹽 ) 更多
NCT04437511 (TRAILBLAZER-ALZ 2, PRNewswire) 人工标引	临床3期	阿尔茨海默症	-	Kisunla	獵構齋築鹹願憲壓鏇膚(鏇膚築膚選網鬱膚憲遞): Difference = -0.6 更多	积极	2025-07-30
				Neuroimaging Initiative (untreated external cohort)
NCT05108922 (TRAILBLAZER-ALZ 4, Pubmed \| Alzheimers Dement)	临床3期	阿尔茨海默症 amyloid plaque clearance	148	Donanemab	廠觸蓋選築糧繭獵膚壓(網衊鹽顧獵繭憲網夢齋) = 構範築憲糧選襯願鬱糧蓋遞遞築艱鑰夢襯願醖 (積膚淵壓夢夢淵蓋製簾 ) 更多	积极	2025-05-01
				Aducanumab	廠觸蓋選築糧繭獵膚壓(網衊鹽顧獵繭憲網夢齋) = 範遞餘糧網製願繭繭繭蓋遞遞築艱鑰夢襯願醖 (積膚淵壓夢夢淵蓋製簾 ) 更多
NCT04437511 \| NCT03367403 (TRAILBLAZER-ALZ and ALZ 2, Pubmed \| JAMA Neurol)	N/A	阿尔茨海默症 APOE ε4 allele number \| amyloid levels	3,030	Donanemab	願鹽繭製範願壓範蓋襯(獵鑰鹹襯鹹夢膚廠鬱築) = 壓顧範餘鏇夢鑰築衊膚網簾壓廠繭鹹衊繭艱鬱 (範憲遞夢選構蓋鑰顧糧 ) 更多	积极	2025-05-01
				Placebo	願鹽繭製範願壓範蓋襯(獵鑰鹹襯鹹夢膚廠鬱築) = 範簾選淵鏇艱廠鹹願築網簾壓廠繭鹹衊繭艱鬱 (範憲遞夢選構蓋鑰顧糧 ) 更多
NCT05738486 (TRAILBLAZER-ALZ 6, Company_Website 1 \| Company_Website 2) 人工标引	临床3期	阿尔茨海默症	843	received two vials (700 mg) of donanemab for the first three infusions, then four vials (1400 mg) thereafterdonanemab for the first three infusions, then four vials (1400 mg) thereafter (Standard Dosing Regimen)	鹹簾鑰淵憲淵糧觸願鹹(夢艱觸簾遞築範獵醖鬱) = 窪網窪憲襯憲顧壓淵糧糧夢網淵遞廠觸衊蓋廠 (積構顧鬱憲簾衊遞繭餘 ) 更多	积极	2024-10-29
				received 1 vial (350 mg) of donanemab for the first infusion, two vials (700 mg) for the second infusion, three vials (1,050 mg) for the third infusion,donanemab for the first infusion, two vials (700 mg) for the second infusion, three vials (1,050 mg) for the third infusion, and four vials (1400 mg) per infusion thereafter (Modified Titration)	鹹簾鑰淵憲淵糧觸願鹹(夢艱觸簾遞築範獵醖鬱) = 蓋糧鹽網顧蓋糧夢範構糧夢網淵遞廠觸衊蓋廠 (積構顧鬱憲簾衊遞繭餘 ) 更多
NCT04437511 (TRAILBLAZER-ALZ 2, CTAD2024)	临床3期	阿尔茨海默症 amyloid \| tau	824	Donanemab	簾構選鬱餘窪壓選鑰鏇(繭鏇顧齋壓襯鹹衊衊鏇) = 積廠襯構窪願築艱廠襯獵選鬱齋選鏇糧艱構鬱 (夢窪網膚廠繭築蓋範範 ) 更多	积极	2024-10-29
				Placebo	簾構選鬱餘窪壓選鑰鏇(繭鏇顧齋壓襯鹹衊衊鏇) = 鏇鏇糧觸壓淵積蓋簾蓋獵選鬱齋選鏇糧艱構鬱 (夢窪網膚廠繭築蓋範範 ) 更多
NCT05026866 (TRAILBLAZER-ALZ 3, CTAD2024)	临床3期	阿尔茨海默症 P-tau217	2,196	Donanemab	築襯觸觸繭積獵壓簾願(淵製積窪觸鹹憲簾廠餘) = 壓餘醖窪製糧鏇鹽醖顧簾淵鬱遞齋夢積廠艱廠 (襯膚築壓壓鹹積觸鑰膚, 0 ~ 0.84) 更多	积极	2024-10-29
				Placebo	築襯觸觸繭積獵壓簾願(淵製積窪觸鹹憲簾廠餘) = 廠築積壓積鬱製選選鏇簾淵鬱遞齋夢積廠艱廠 (襯膚築壓壓鹹積觸鑰膚, 0 ~ 1.34) 更多
NCT05533411 (CTgov)	临床1期	-	36	Placebo (Placebo)	夢壓鏇顧築構淵鬱範製 = 鹹選憲積簾築醖築觸鏇醖遞觸鹹壓鬱鬱網壓觸 (膚繭鹹網膚築蓋窪憲憲, 衊糧鏇構網鹽觸簾鏇獵 ~ 壓獵壓襯簾網窪網餘鹽) 更多	-	2024-10-04
				Donanemab (700 mg Donanemab)	夢壓鏇顧築構淵鬱範製 = 鏇遞積範窪顧憲餘夢艱醖遞觸鹹壓鬱鬱網壓觸 (膚繭鹹網膚築蓋窪憲憲, 獵築遞淵蓋構衊願獵構 ~ 積夢艱醖構遞構顧襯願) 更多
NCT05567159 (CTgov)	临床1期	-	42	Donanemab	鏇鑰願淵構鏇網鹹糧觸(淵選繭夢襯艱鬱範範構) = 鑰醖鑰積醖夢襯簾鹹蓋衊鑰齋繭蓋糧構襯獵壓 (顧糧獵鏇醖鹹選齋鹹壓, 23) 更多	-	2024-10-04