A Phase III, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease

A study to evaluate the efficacy and safety of gantenerumab in amyloid-positive, cognitively unimpaired participants at risk for or at the earliest stages of AD. The planned number of participants for this study is approximately 1200 participants randomized in a 1:1 ratio to receive either gantenerumab or placebo (600 participants randomized to gantenerumab and 600 participants randomized to placebo).

开始日期2022-04-19

申办/合作机构

Hoffmann-La Roche, Inc.

CTR20210207

/ Completed临床1期

一项在健康中国受试者中考察单次腹部皮下注射GANTENERUMAB高浓度液体制剂后药代动力学、安全性和耐受性的单中心、开放性、I期研究

本研究将在健康中国受试者中评价G4工艺生产的gantenerumab在单次皮下注射510 mg剂量后的药代动力学、安全性和耐受性特征。 1. 药代动力学目的：根据以下终点，描述健康中国受试者单次SC注射（510 mg）gantenerumab的药代动力学特征： ● 主要PK参数：AUCinf和Cmax ● 次要PK参数：AUC0-672h、AUC0-last、t1/2（如下方法计算：ln 2/消除速率常数[λz]）、表观清除率（CL/F）、非静脉给药后的终末期分布容积（Vz/F） 2. 安全性目的根据以下终点，评价健康中国受试者单次SC注射（510 mg）gantenerumab的安全性和耐受性： ● 不良事件的性质、发生率、严重程度和因果关系 ● 使用视觉模拟量表（VAS）和言语评定量表（VRS）进行局部疼痛评估 ● 异常实验室检查结果、异常生命体征和异常心电图的发生率 ● ISR的发生率（局部和全身） 3. 免疫原性目的根据以下终点评价受试者对gantenerumab的免疫应答： ● 研究期间gantenerumab抗药抗体（ADA）发生率相对基线时ADA发生率的变化

开始日期2021-06-02

申办/合作机构

F. Hoffmann-La Roche Ltd.

[+1]

NCT04374253

/ Terminated临床3期

An Open-Label, Multicenter, Rollover Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease

This is an open-label, multicenter, rollover study to evaluate the safety, tolerability, and efficacy of long-term administration of open-label gantenerumab in participants with AD who completed Study WN29922 or WN39658, either the double-blind or open-label extension (OLE) part.

开始日期2021-01-26

申办/合作机构

Hoffmann-La Roche, Inc.

100 项与甘特鲁单抗相关的临床结果

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100 项与甘特鲁单抗相关的转化医学

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100 项与甘特鲁单抗相关的专利（医药）

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117

项与甘特鲁单抗相关的文献（医药）

2025-11-01·CNS & Neurological Disorders-Drug Targets

Trends in Research on Gantenerumab for Alzheimer’s Disease: A Bibliometric and Thematic Analysis

Article

作者: Taha, Manal Mohamed Elhassan ; Albasheer, Osama ; Ali, Sohaila ; Babiker, Yasir Osman Hassan ; Gohal, Gassem ; Farasani, Abdullah ; Abdelwahab, Siddig Ibrahim ; Alfaifi, Hassan Ahmad ; Aljahdali, Ieman A. ; Oraibi, Bassem ; Oraibi, Omar ; Alzahrani, Amal Hamdan ; Ahmed, Anas A. ; Jerah, Ahmed Ali

Background::

Gantenerumab (GR), a promising therapeutic agent for Alzheimer's disease (AD), has been the subject of extensive research. In this study, we aimed to provide a comprehensive analysis of the literature on GR.

Methods::

A systematic search was conducted using the PubMed, Scopus, and Web of Science databases. VOSviewer and Bibliometrix were utilized to analyze bibliographic data.

Results::

The analysis of the literature on GR revealed distinct publication trends. Reviews accounted for 52% of the records, followed by research articles (31%). The United States contributed the highest proportion of publications (26%). The Journal of Prevention of Alzheimer’s Disease was the most prolific source (21 articles). The annual number of publications increased steadily from 2009 to 2024. Major international collaborations were observed among the United States, the United Kingdom, Switzerland, France, and Sweden. Research activity consistently centered on key themes, such as amyloid imaging, biomarkers, clinical trials, and β-amyloid. Thematic mapping identified specialized subfields, core research areas, and dynamic shifts in topics, offering a comprehensive overview of the GR research landscape.

Conclusion::

GR-related literature showed sustained thematic focus, growing international collaboration, and a steady rise in publication volume within the field of AD. These findings highlight the continued need for clinical and biomarker-focused investigations to advance therapeutic development in AD.

2025-09-01·JOURNAL OF ALZHEIMERS DISEASE

The structural foundations of anti-amyloid-β immunotherapies: Unravelling antibody-antigen interactions in Alzheimer's disease treatment

Review

作者: Miles, Luke A ; Masters, Colin L

Background:

Anti-amyloid-β (Aβ) immunotherapies are emerging as treatments for Alzheimer's disease (AD).

Objective:

This review examines the structure-activity relationships of anti-Aβ therapeutics tested in phase 3 trials.

Methods:

We analyzed crystallographic data and molecular models to elucidate the Aβ binding mechanisms of donanemab, lecanemab, aducanumab, bapineuzumab, gantenerumab, solanezumab, and crenezumab.

Results:

Lecanemab recognizes minimally degraded Aβ missing 1–2 residues, avoiding common Aβ in circulation and further degraded material sequestered in plaques. Bapineuzumab buries the N-terminus of Aβ requiring Asp1 and is reactive with benign, common Aβ. Donanemab buries the truncated N-Glu3 terminus with strong contacts engaging the cyclized pyro-Glu3 modification. Gantenerumab shows lecanemab-like properties but also binds common Aβ. Aducanumab likely needs mAb-mAb cooperation to scavenge a spectrum of Aβ oligomers explaining higher doses. Solanezumab and crenezumab target a pre-amyloid epitope resulting in off-target engagement, including monomers and likely excluding Aβ-ApoE complexes.

Conclusions:

Preventing primary Aβ nucleation failed due to limitations imposed by the blood-brain barrier, intracellular aggregation routes, and the natural abundance of Aβ. Anti-Aβ monoclonal antibody therapies in clinical use capture Aβ at various stages of decay where post translational modifications have been used effectively as proxies for time spent in vivo. By targeting a relatively labile epitope of aging Aβ, lecanemab selects more biologically active species of Aβ avoiding both benign monomers and old fortified species. This focal point may account for the significant cognitive effects of lecanemab. The structure of aducanumab suggests a broadly neutralizing role has evolved for natural immunity to AD.

2025-08-19·Current Neuropharmacology

Structural and Functional Determinants of ARIA-H Risk in Anti-Amyloid Monoclonal Antibodies: A Comparative Mechanistic Framework for Alzheimer's Immunotherapy Development

Article

作者: Xu, Yun ; Zou, Xinxin ; An, Dinghao

Introduction::

Amyloid-beta-targeting monoclonal antibodies (mAbs) for Alzheimer's disease frequently induce amyloid-related imaging abnormalities with hemorrhage (ARIA-H), yet systematic comparisons of ARIA-H incidence across therapeutic agents remain limited. Post-approval research prioritizes dosing over mechanism, leaving unresolved whether ARIA-H variations originate from intrinsic mAb properties. We address two gaps: comparative ARIA-H risk stratification among clinically available/investigational mAbs, and elucidation of structural/functional features influencing ARIA-H susceptibility.

Methods::

A systematic comparison of seven mAbs (donanemab, aducanumab, bapineuzumab, lecanemab, gantenerumab, crenezumab, solanezumab) was conducted, analyzing clinical trial data and molecular characteristics.

Results::

ARIA-H incidence ranked as follows (highest to lowest): donanemab > aducanumab > bapineuzumab > lecanemab > gantenerumab > crenezumab > solanezumab. Five mAb-specific determinants emerged: (1) Types of Aβ Binding: Enhanced clearance of mature amyloid plaques correlated with elevated ARIA-H risk. (2) Polymer binding Affinity: Reduced small oligomer-binding capacity predicted higher ARIA-H incidence. (3) Epitope location: N-terminal-targeting mAbs showed greater ARIA-H incidence vs. mid/C-terminal binders. (4) Fc region structure: IgG4-based constructs showed higher ARIA-H incidence than IgG1 analogs. (5) Clearance kinetics: Rapid attainment of amyloid reduction thresholds amplified ARIA-H incidence.

Discussion::

We identify a risk hierarchy for ARIA-H among anti-Aβ mAbs and link specific mAb biophysical properties—Aβ binding type, affinity for soluble oligomers, epitope specificity, Fc structure, and plaque clearance dynamics—directly to ARIA-H pathogenesis.

Conclusion::

These findings establish a mechanistic framework for ARIA-H risk and provide concrete molecular predictors to guide antibody engineering strategies. Prioritizing mAbs with controlled amyloid clearance, C-terminal binding domains, and IgG1 frameworks may enhance therapeutic safety, advancing precision immunotherapy for Alzheimer's disease.

298

项与甘特鲁单抗相关的新闻（医药）

2025-08-14

·药通社

971无了，还有中药！

8月12日，知名治疗阿尔兹海默症（AD）药物，甘露特纳胶囊（俗称971胶囊）被下发了通知件，依据受理号推断，应当是附条件审批转常规审批失败。相关文章：绿谷制药971，再注册失败！这款治疗阿尔茨海默病的争议性药物正式退出市场，而失败原因推测是IV期临床试验结果不佳。 971胶囊无了，那么其他治疗AD的药物，还有么？ ↓ 扫码加入药通社交流群 ↓ 971无了，还有中药！ 6月18日，华西医院招募阿尔茨海默症的中药创新药KH110（五加益智颗粒）临床III期受试者的消息传来，诸多患者要求入组参与试验。图源：药圈观察局相较于昂贵的单抗治疗，中药治疗AD，或许是新方法？事实上，国内一些中药创新药先驱企业早已开始行动。首先是上文提到的，康弘药业旗下四川济生堂自主研发的KH110（五加益智颗粒），现已进入临床III期。该药用于脾肾两虚所致痴呆，适用于轻、中度AD患者。主要疗效指标为治疗12个月后，与安慰剂组阿尔茨海默病评定量表-认知部分（ADAS-cog/12）评分及临床痴呆评定量表（CDR-SB）较基线改变的组间差异。与此同时，康缘医药正在进行苁蓉总苷胶囊治疗轻中度AD（髓海不足证）Ⅱ期临床试验。首例受试者已于2025年4月14日签署知情同意书，计划入组136例，主要评估阿尔茨海默病评价量表-认知子量表（ADAS-cog/11）认知评分变化及不良事件，评价周期为用药前至用药后24周。除此之外，北京恒清堂医药也在进行参芪醒脑颗粒治疗轻度阿尔茨海默病的Ⅱ期临床研究。主要终点为36周治疗结束后阿尔茨海默病评价量表-认知部分（ADAS-Cog）评分变化，目标入组160人，目前已完成入组。这之中，进度最快的是四川济生堂。时间分析，如果临床试验顺利，最早2026年底能有III期临床试验数据。预计完成临床之后，就会提交上市。这么看来，未来中药治AD或真将成为可能？放眼全球，AD市场到底有多庞大？答案是：平均每3秒增加1例患者。据WHO数据，2023年全球 AD 患者已超 5500 万，预计2050 年将增至 1.39 亿，每3秒就会增加1例患者。而中国是全球 AD 患者最多的国家。据中国阿尔茨海默病协会（ADC）2023 年统计，我国 AD 患者约 983 万，预计 2030 年将突破 1900 万。正因如此，AD庞大的患病人群吸引着各大企业争相研发，但结果却一言难尽。 2012年，强生/辉瑞的单抗药物Bapineuzumab的III期临床试验失败； 2014年，罗氏宣告Gantenerumab的III期临床试验失败； 2016年，礼来宣告III期临床药物Solanezumab没有达到主要临床终点； 2017年，默沙东宣布停止开发BACE抑制剂药物Verubecestat； 2018年，强生宣布其终止了BACE抑制剂剂Atabecestat II/III期临床试验...... 最接近成功的一次，是2021年6月，FDA批准卫材和渤健共同研发的Aduhelm终于成功上市，那是第一款基于Aβ级联的药物，也是第一款治疗AD本身的药物。然而虽然Aduhelm在美国顶着腥风血雨上市了，但因其存在明显副作用，且价格极其昂贵（年治疗费高达5.8万美金），上市后难以推广，最终卫材和渤健选择停止了Aduhelm的商业化进程。失败案例不胜枚举，也因此，阿尔茨海默病的新药研发被行业称作“地狱级”挑战，甚至被业内形容为“死亡之谷”，失败率高达99.6％。市场如此庞大，研发了这么多年，但AD治疗药物依然寥寥可数。截至目前，能够同时被美、欧、日、中多国所认可的早期AD治疗药物，却只有两款：一款是卫材和渤健的仑卡奈单抗；另一款是礼来的多奈单抗。 2023年1月，还是卫材和渤健，首次Aduhelm的研发成功让他们找到了AD药物的研究路径，也就是目前最被大众认可的基于淀粉样蛋白假说的研发路径。基于Aduhelm的经验，终于开发出了首款FDA完全批准的Aβ单抗药物（仑卡奈单抗），用于治疗早期AD患者，成为全球首个能延缓AD进程的药物。 2024年7月，礼来上市了第二款Aβ单抗药物，多奈单抗，一经上市就备受质疑，据实验数据显示多奈单抗副作用发生几率远高于仑卡奈单抗，今年7月，礼来更新了多奈单抗的给药方式，可有效降低副作用发生率。质疑声逐渐变小，但这两款药物还有一个最大的问题：治疗费用过于昂贵，在国内两款药都不进医保，对患者及其家属来说负担太重。过高价格导致这两款药在上市起质疑声就不断，且仑卡奈单抗和多奈单抗仅适用于早期AD患者，对于中、重度AD治疗依旧束手无策。 AD药物，各有各的难，未来之路，任重而道远！或许真的靠中药了？参考： [1]医耀—阿尔兹海默病走出“技术沉没周期” [2]药圈观察局—中药AD新药，已进入临床III期 [3]中种看药—阿尔茨海默病新药研发进展及康缘药业所处位置本文截图均来自：摩熵医药 ↓关注药通社，洞见行业趋势↓ 投稿/企业合作/内容沟通：药通社总编—华籍美人（Ww_150525） *添加请注明企业及来意

临床2期临床3期抗体药物偶联物申请上市临床失败

2025-08-04

·EINPresswire

Biomed Industries Presents Four Breakthrough Studies on Alzheimer’s, Rett Syndrome, and Obesity Therapies at AAIC 2025

Biomed Industries, Inc. Presents Four Pivotal Studies at AAIC 2025 Highlighting Breakthrough Therapies for Alzheimer’s, Rett Syndrome, and Obesity NA-831 is the only drug to date that has halted Alzheimer’s disease progression. Combining it with existing drugs like Donanemab could optimize therapeutic efficacy and reduce serious side effects.” — Dr. Lloyd L. Tran, CEO of Biomed SAN JOSE, CA, UNITED STATES, August 4, 2025 / EINPresswire.com / -- Biomed Industries, Inc., a leading biopharmaceutical innovator developing transformative therapies for neurological and metabolic diseases, today announced the presentation of four major scientific papers at the Alzheimer’s Association International Conference (AAIC), held July 27–31, 2025, in Toronto, Canada. The presentations featured Biomed’s next-generation oral therapies for Alzheimer’s disease, Rett syndrome, and obesity, with a focus on novel combination strategies designed to enhance safety, efficacy, and accessibility. Featured AAIC 2025 Presentations: 1. The End of the Amyloid Era? Evidence for a Paradigm Shift in the Quest to Treat Alzheimer’s Disease 2. A Phase 3 Clinical Protocol of NA-831 Combined with Donanemab in Early Alzheimer’s Disease: A Placebo-Controlled, Double-Blind Study 3. Associations Between Alzheimer’s Disease and Rett Syndrome: Clinical Trials of NA-831 and NA-921 4. Neuro-Metabolic Link Between Alzheimer’s Disease and Obesity: Clinical Evaluation of NA-831 and NA-931 1. PRESENTATION: The End of the Amyloid Era? A Paradigm Shift in Alzheimer’s Research For over three decades, the “amyloid hypothesis” has dominated Alzheimer’s disease (AD) research, asserting that amyloid-β accumulation is a primary driver of neurodegeneration. Biomed’s comprehensive analysis of Phase 3 trial data from seven anti-amyloid drugs — including aducanumab, lecanemab, donanemab, gantenerumab, bapineuzumab, crenezumab, and solanezumab — challenges this paradigm. Across all trials, both treatment and placebo groups exhibited similar cognitive decline, as measured by CDR-SB and ADAS-Cog. The average differences between treatment and placebo arms were minor and not clinically significant (CDR-SB: -0.25; ADAS-Cog: -0.79). Slope comparisons further revealed near-identical rates of decline between groups. “Our analysis of Phase 3 clinical trial data for seven anti-amyloid drugs, including FDA-approved Aducanumab, Lecanemab, and Donanemab, indicates that none could halt disease progression in a clinically meaningful way — and all carried serious safety concerns,” said Dr. Zung Tran, VP of Biostatistics and AI at Biomed. 2. PRESENTATION: Phase 3 Clinical Protocol of NA-831 Combined with Donanemab NA-831, Biomed’s lead oral candidate, is a first-in-class therapy that promotes neuroprotection, neurogenesis, and memory enhancement. Phase 2 trials demonstrated its disease-modifying potential with a favorable safety profile compared to traditional anti-amyloid drugs. In this upcoming Phase 3 study, NA-831 will be evaluated in combination with Donanemab, a recently FDA-approved monoclonal antibody, to explore synergistic effects. The goal is to lower Donanemab dosing, thereby reducing risks such as cerebral edema and microbleeds, while enhancing cognitive outcomes. “NA-831 is the only drug to date that has halted disease progression in Phase 2 trials,” said Dr. Lloyd Tran, CEO of Biomed Industries. “Combining it with existing drugs like Donanemab could optimize therapeutic efficacy and reduce serious side effects.” 3. PRESENTATION: Alzheimer’s and Rett Syndrome: Shared Mechanisms and Dual Therapeutic Potential Biomed also presented findings on NA-921, a structural analog of NA-831 developed for Rett syndrome, a rare X-linked neurodevelopmental disorder. NA-921 modulates MeCP2 expression, targeting the disorder’s core epigenetic dysfunction. A double-blind, placebo-controlled Phase 2/3 trial (ClinicalTrials.gov ID: NCT06849973) demonstrated promising results: Clinical Global Impression–Improvement (CGI-I) at week 12: NA-921: 3.60 | Placebo: 3.83 | P = 0.0020 | Effect size = 0.42 NA-921 was well tolerated, with a significantly improved safety profile compared to trofinetide: - Diarrhea: Trofinetide 82%, NA-921 24%, Placebo 19% - Vomiting: Trofinetide 29%, NA-921 9%, Placebo 11% - Fever: Trofinetide 9%, NA-921 5%, Placebo 4% These findings underscore a possible biological link between Alzheimer’s disease and Rett syndrome, opening new cross-indication opportunities for NA-831 and NA-921. 4. PRESENTATION: Neuro-Metabolic Connections: NA-831 and NA-931 in Alzheimer’s and Obesity Biomed’s data also revealed compelling evidence of a neuro-metabolic bridge between Alzheimer’s disease, diabetes, and obesity. In addition to NA-831’s CNS benefits, Biomed is advancing NA-931, an oral quadruple receptor agonist (IGF-1, GLP-1, GIP, and glucagon) designed to treat obesity. In a 13-week Multiple Ascending Dose (MAD) study: - Mean body weight reduction: Up to 13.8% at 150 mg daily, 12.4% greater than placebo - ≥12% weight loss achieved by 72% of NA-931-treated patients vs. 2% in placebo group NA-931 demonstrated a strong safety profile, with mild and transient GI-related adverse events, and no observed muscle loss. “Our pipeline shows how targeting interconnected pathways across the CNS and metabolic systems can unlock significant clinical potential,” said Michael Willis, VP of Business Development. “With six active programs across Alzheimer’s, ALS, Rett syndrome, stroke, obesity, and MASH, we are building a diversified platform to accelerate innovation and value creation.” ABOUT BIOMED INDUSTRIES, INC. Biomed Industries, Inc. is a pioneering biopharmaceutical company committed to developing novel therapeutics that address unmet medical needs. Its innovative research platform has produced treatments for conditions including Alzheimer’s disease, ALS, Traumatic Brain Injury, Major Depressive Disorder, Diabetes, Obesity, MASH, Stroke, and rare diseases such as Huntington Disease and Rett Syndrome. (Website: https://www.biomedind.com ) Michael Willis Biomed Industries, Inc. email us here Visit us on social media: LinkedIn X Biomed introduction video Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

临床结果临床2期临床3期

2025-08-02

·药研发

【药研日报0802】诺和诺德口服GLP-1药物Amycretin在肥胖症II期试验中展现优越减重效果

「本文共：15条资讯，阅读时长约：20分钟」药研资讯1. 诺和诺德口服GLP-1药物Amycretin在肥胖症II期试验中展现优越减重效果。诺和诺德（Novo Nordisk）公布了其口服GLP-1/胰淀素受体激动剂Amycretin的II期临床试验积极数据。结果显示，经过20周治疗，患者体重减轻幅度显著超过了Wegovy（司美格鲁肽）。这一结果可能预示着口服减重药物市场的下一个重大突破，引发了公司股价和业界的高度关注。2. 辉瑞（Pfizer）宣布以116亿美元收购一家专注于ADC药物的生物技术公司。辉瑞公司宣布达成最终协议，将以约116亿美元的价格收购生物技术公司Seagen。此次收购将极大增强辉瑞在抗体药物偶联物（ADC）领域的管线和技术平台，特别是在肿瘤治疗领域，被视为辉瑞应对专利悬崖、加强其癌症药物组合的关键战略举措。3. FDA批准首款用于治疗非酒精性脂肪性肝炎（NASH）的药物。美国食品药品监督管理局（FDA）今日批准了Madrigal Pharmaceuticals公司的Rezdiffra（resmetirom），用于治疗伴有中度至晚期肝纤维化的非酒精性脂肪性肝炎（NASH）。这是全球首款获批的NASH疗法，填补了巨大的未满足医疗需求，为数百万患者带来了希望。4. CRISPR基因编辑疗法在罕见遗传病β-地中海贫血的III期研究中获得成功。Vertex Pharmaceuticals和CRISPR Therapeutics联合宣布，其合作开发的exagamglogene autotemcel（exa-cel）在针对输血依赖性β-地中海贫血的III期临床试验中达到了主要终点和关键次要终点。绝大多数患者在接受治疗后摆脱了对输血的依赖，展示了基因编辑技术的巨大潜力。5. 罗氏（Roche）公布其阿尔茨海默病新药Gantenerumab的最新III期数据。罗氏公布了其皮下注射β-淀粉样蛋白抗体Gantenerumab在阿尔茨海mer病III期GRADUATE研究的最新分析数据。虽然未能达到主要临床终点，但数据显示其对特定亚组患者的生物标志物有积极影响。公司表示将继续探索其潜力，引发了学界对阿尔茨海默病治疗路径的进一步讨论。6. Moderna启动针对新型冠状病毒变种的mRNA疫苗III期临床试验。随着新一轮新冠病毒变种的出现，Moderna宣布启动其最新一代COVID-19疫苗的全球III期临床试验。该疫苗旨在提供针对当前主要流行株的更强和更持久的保护。7. 默沙东（MSD）Keytruda联合化疗获批用于治疗特定类型的晚期胃癌新适应症。美国FDA批准了默沙东的PD-1抑制剂Keytruda（帕博利珠单抗）联合曲妥珠单抗和化疗，用于一线治疗HER2阳性的晚期胃或胃食管交界处腺癌。这为胃癌患者提供了一个重要的免疫治疗新选择。8. 礼来（Eli Lilly）公布其下一代GIP/GLP-1R激动剂Retatrutide在2型糖尿病中的III期研究数据。礼来公司公布了其三重激动剂Retatrutide在治疗2型糖尿病患者的III期试验中的积极顶线结果。数据显示其在降糖和减重方面均表现出非常强劲的效力，有望成为继替尔泊肽（Tirzepatide）之后的又一重磅产品。9. 拜耳（Bayer）剥离其部分消费者健康业务，以更专注于处方药和农业科学。为应对财务压力和聚焦核心业务，拜耳集团宣布计划出售其部分知名的消费者健康品牌组合。此举旨在精简公司结构，将更多资源投入到医药和作物科学的创新研发中。10. CAR-T细胞疗法在实体瘤领域取得新进展：一项针对胶质母细胞瘤的早期研究结果积极。一家新兴生物技术公司公布了其新型CAR-T细胞疗法在治疗复发性胶质母细胞瘤（GBM）的I期临床试验中的初步数据。结果显示，该疗法具有良好的安全性，并在部分患者中观察到了肿瘤缩小的迹象，为CAR-T技术攻克实体瘤带来了新希望。11. 安进（Amgen）心血管重磅药物Repatha（瑞百安）的一项新适应症申请获欧洲药品管理局（EMA）受理。安进公司宣布，欧洲药品管理局已受理其PCSK9抑制剂Repatha用于降低特定高危人群主要心血管事件风险的新适应症上市许可申请。12. 百时美施贵宝（BMS）与一家AI药物发现公司达成数亿美元的合作协议。百时美施贵宝宣布与一家领先的人工智能（AI）药物研发公司达成战略合作，旨在利用AI平台发现和开发针对数个肿瘤学和免疫学靶点的新型小分子疗法。该合作总金额可达数亿美元。13. 吉利德科学（Gilead Sciences）公布其长效HIV药物Lenacapavir的最新预防数据。吉利德公布了其每年两次的衣壳抑制剂Lenacapavir作为HIV暴露前预防（PrEP）用药的一项关键研究数据，显示出极高的保护效力。长效剂型将极大改变HIV的预防格局。14. 全球首个基于RNAi技术的降胆固醇药物Leqvio在中国的商业化上市。诺华（Novartis）宣布其RNA干扰（RNAi）疗法Leqvio（inclisiran）已在中国正式上市。该药物每年仅需注射两次，为高胆固醇血症患者提供了长效、便捷的治疗新选择。15. 赛诺菲（Sanofi）投资开发新型抗生素以应对“超级细菌”耐药性危机。面对全球日益严重的抗生素耐药性问题，赛诺菲宣布对一家专注于开发新型抗菌药物的生物技术公司进行战略投资，并与其展开合作，共同研发能够对抗多重耐药菌的新一代抗生素。股市资讯8月1日A股医药公司涨幅TOP 3百济神州（688235.SH） +18.25%主要影响因素：PD-1单抗替雷利珠单抗获FDA批准用于胃癌一线治疗，成为首个在美获批该适应症的国产PD-1。康希诺（688185.SH） +14.36%主要影响因素：与Gavi签署15亿美元新冠疫苗预购协议，覆盖中低收入国家2026年需求。华东医药（000963.SZ） +11.78%主要影响因素：GLP-1受体激动剂利拉鲁肽类似药获批上市，定价较原研低40%。8月1日A股医药公司跌幅TOP 3ST康美（600518.SH） -5.00%主要影响因素：因持续经营能力存疑被实施退市风险警示。华大基因（300676.SZ） -4.35%主要影响因素：新冠检测业务继续萎缩，上半年净利润同比下滑52%。以岭药业（002603.SZ） -3.12%主要影响因素：连花清瘟海外销售不及预期，遭多家投行下调目标价。8月1日港股医药公司涨幅TOP 3信达生物（01801.HK） +22.17%主要影响因素：与赛诺菲达成50亿美元双抗ADC合作，首付款3亿美元创国内纪录。药明生物（02269.HK） +16.89%主要影响因素：宣布新建全球最大生物药CDMO基地，总投资100亿元。金斯瑞生物（01548.HK） +13.45%主要影响因素：CAR-T疗法获欧盟批准用于多发性骨髓瘤二线治疗。8月1日港股医药公司跌幅TOP 3中国生物制药（01177.HK） -7.23%主要影响因素：核心产品安罗替尼遭医保局重点监控，预计年销售额减少30%。石药集团（01093.HK） -5.67%主要影响因素：阿尔茨海默病药物III期临床数据不及预期，终止研发。三生制药（01530.HK） -4.89%主要影响因素：大股东折价12%减持8000万股，套现约6亿港元。评审动态8月1日新药临床试验申请IND7月新药上市申请NDA（申请类型为新药或进口，不包括仿制&已有国家标准）END

临床3期并购信使RNA疫苗临床2期

100 项与甘特鲁单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09713	甘特鲁单抗	-	DB12034

研发状态

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
阿尔茨海默症	临床3期	阿根廷	Hoffmann-La Roche, Inc.	2010-11-30
阿尔茨海默症	临床3期	智利	Hoffmann-La Roche, Inc.	2010-11-30
阿尔茨海默症	临床3期	捷克	Hoffmann-La Roche, Inc.	2010-11-30
阿尔茨海默症	临床3期	芬兰	Hoffmann-La Roche, Inc.	2010-11-30
阿尔茨海默症	临床3期	墨西哥	Hoffmann-La Roche, Inc.	2010-11-30
阿尔茨海默症	临床3期	荷兰	Hoffmann-La Roche, Inc.	2010-11-30
阿尔茨海默症	临床3期	波兰	Hoffmann-La Roche, Inc.	2010-11-30
阿尔茨海默症	临床3期	葡萄牙	Hoffmann-La Roche, Inc.	2010-11-30
阿尔茨海默症	临床3期	瑞典	Hoffmann-La Roche, Inc.	2010-11-30
阿尔茨海默症	临床3期	瑞士	Hoffmann-La Roche, Inc.	2010-11-30

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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


NCT01760005 \| NCT06424236 (DIAN-TU-001, Pubmed) 人工标引	临床2/3期	阿尔茨海默症	74	gantenerumab (any gantenerumab)	廠鑰築獵範鬱願網鑰獵(蓋膚鹽鹽選壓壓製繭積) = At the interim analysis, the hazard ratio for clinical decline of CDR-SB in asymptomatic mutation carriers was 0·79 (n=53 [95% CI 0·47 to 1·32]) for participants who were treated with gantenerumab in either the double-blind or OLE period (Any Gant), and 0·53 (n=22 [0·27 to 1·03]) for participants who were treated with gantenerumab the longest (Longest Gant). 艱艱廠淵獵醖築鏇窪築 (獵淵憲鏇夢淵築繭膚願 ) 更多	积极	2025-04-01
				gantenerumab (Longest gantenerumab)
NCT06424236 (DIAN-TU, CTgov)	临床2/3期	阿尔茨海默症	73	OLE+Gantenerumab (Double-blind Placebo - OLE Gantenerumab)	積構壓憲膚鏇餘壓選鑰(夢鹽顧獵夢遞壓淵築膚) = 範獵鹹築廠鹽壓齋獵繭艱網觸顧鏇獵鑰糧獵艱 (憲繭顧構遞鏇憲鏇夢廠, 0.22606) 更多	-	2025-02-04
				Gantenerumab+Solanezumab (Double-blind Solanezumab - OLE Gantenerumab)	積構壓憲膚鏇餘壓選鑰(夢鹽顧獵夢遞壓淵築膚) = 齋衊獵願構獵鑰網選蓋艱網觸顧鏇獵鑰糧獵艱 (憲繭顧構遞鏇憲鏇夢廠, 0.40538) 更多
NCT03443973 \| NCT04374253 \| NCT03444870 (GRADUATE I/II, Pubmed \| JAMA Neurol)	临床3期	阿尔茨海默症 Fazekas score \| total superficial siderosis count \| total microhemorrhage count ... 更多	1,939	Gantenerumab	鏇衊製窪廠鏇齋選鹽鏇(繭衊觸憲廠艱繭願夢築) = 製襯鏇糧範齋憲製繭膚遞願壓餘鹽襯齋衊餘選 (鑰壓積選糧觸廠觸憲衊 ) 更多	积极	2024-11-18
NCT05256134 (SKYLINE, CTgov)	临床3期	阿尔茨海默症	25	Placebo (Placebo)	積顧遞鏇憲繭窪積願糧(襯蓋顧淵淵鬱衊構顧鹹) = 願網遞製網觸簾顧鏇範繭憲齋蓋鑰醖糧獵願願 (鹽窪窪簾襯淵獵網鑰積, 0.5790) 更多	-	2024-07-09
				Gantenerumab (Gantenerumab)	積顧遞鏇憲繭窪積願糧(襯蓋顧淵淵鬱衊構顧鹹) = 積蓋繭餘憲膚艱網觸觸繭憲齋蓋鑰醖糧獵願願 (鹽窪窪簾襯淵獵網鑰積, 0.6038) 更多
NCT04374253 (CTgov)	临床3期	阿尔茨海默症	1,382	Placebo (Placebo: Participated in Graduate OLE)	憲鹹艱選構糧醖網窪製 = 簾襯遞築蓋壓鏇範鏇顧蓋鹹壓襯壓顧餘願製網 (顧觸淵構鏇壓壓壓齋壓, 鹽網餘糧衊餘糧膚築簾 ~ 醖鬱繭糧製鬱齋遞繭鑰) 更多	-	2024-05-08
				Placebo (Placebo: No Participation in Graduate OLE)	憲鹹艱選構糧醖網窪製 = 蓋獵鏇選簾簾選糧鏇鑰蓋鹹壓襯壓顧餘願製網 (顧觸淵構鏇壓壓壓齋壓, 鏇夢膚鏇夢醖鹹觸選鏇 ~ 糧繭窪壓糧淵獵繭鏇蓋) 更多
NCT04623242 (Pubmed)	临床2/3期	阿尔茨海默症	-	Solanezumab	繭顧鏇鑰鹽廠範積糧壓(簾夢齋鹽築鬱廠衊範觸) = 餘艱膚網遞構選艱鹽築憲觸鏇憲蓋構鹽鏇鬱鏇 (艱壓夢淵鑰觸構繭蓋簾, 0.43)	-	2024-04-29
NCT04592341 (CTgov)	临床2期	阿尔茨海默症	192	Gantenerumab	築觸製廠糧襯齋鹽範顧(觸觸選壓繭網膚積衊顧) = 廠醖獵廠壓顧憲襯餘鑰願範構膚憲窪夢鬱範艱 (積製廠觸夢鑰範獵願醖, 29.80) 更多	-	2024-03-27
NCT03444870 (CTgov)	临床3期	阿尔茨海默症	1,053	placebo+gantenerumab (Global - DBT Period: Placebo)	願衊壓繭艱願鹹鹽襯選(淵醖範範醖蓋廠衊範夢) = 鬱獵築醖鏇齋壓淵憲鏇廠獵襯餘鹽齋網齋衊鑰 (獵蓋構夢願獵鹹淵鏇選, 0.16) 更多	-	2024-01-30
				Gantenerumab (Global - DBT Period: Gantenerumab)	願衊壓繭艱願鹹鹽襯選(淵醖範範醖蓋廠衊範夢) = 淵醖餘網糧範壓廠襯夢廠獵襯餘鹽齋網齋衊鑰 (獵蓋構夢願獵鹹淵鏇選, 0.14) 更多
NCT04339413 (CTgov)	临床3期	阿尔茨海默症	116	Gantenerumab (SCarlet RoAD)	衊鏇齋簾襯襯艱築廠淵 = 壓範窪積築鬱衊艱衊淵範網餘鬱餘製範遞範製 (積簾繭繭鹽鬱窪窪襯衊, 夢範鏇齋製遞壓顧繭顧 ~ 積觸廠積鬱遞壓鬱鬱鏇) 更多	-	2024-01-18
				Gantenerumab (Marguerite RoAD)	衊鏇齋簾襯襯艱築廠淵 = 齋糧構餘壓膚憲選願顧範網餘鬱餘製範遞範製 (積簾繭繭鹽鬱窪窪襯衊, 鑰鑰製淵醖壓鏇淵繭壓 ~ 醖範鬱蓋鏇鏇衊鏇製鹽) 更多
NCT03443973 (CTgov)	临床3期	阿尔茨海默症	975	placebo+gantenerumab (Placebo: DBT)	醖鹽築範簾簾鏇餘願鹹(餘淵衊廠鬱夢構積網鑰) = 製艱壓築顧蓋醖衊膚鹹襯構顧選鹹獵鹽構鏇壓 (網鑰鹹艱鬱膚蓋衊製餘, 0.15) 更多	-	2024-01-17
				Gantenerumab (Gantenerumab: DBT)	醖鹽築範簾簾鏇餘願鹹(餘淵衊廠鬱夢構積網鑰) = 積遞選醖夢構遞遞艱衊襯構顧選鹹獵鹽構鏇壓 (網鑰鹹艱鬱膚蓋衊製餘, 0.14) 更多