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阿尔茨海默病创新药长期随访结果如何?是否安全?最新数据公布
第一财经· 2025-08-02 06:33
Core Viewpoint - Recent innovations in Alzheimer's disease drugs have shown promising results in clinical trials, particularly the long-term efficacy of therapies like donanemab, but concerns about long-term effects and safety remain [3][4]. Group 1: Clinical Trial Results - Eli Lilly's donanemab has demonstrated a significant slowing of disease progression in Alzheimer's patients over a three-year follow-up, with early treatment showing a 27% reduced risk of advancing to the next disease stage compared to delayed treatment [3][4]. - Over 75% of early-treated patients achieved amyloid clearance within 76 weeks, and the rate of amyloid plaque re-deposition was slow at approximately 2.4 CL/year during the longest observation period of 2.5 years [3][4]. Group 2: Safety and Side Effects - No new safety signals were observed during the long-term extension phase of the study, but previously noted issues related to amyloid-targeting treatments, such as ARIA (Amyloid-related imaging abnormalities), remain a concern [4]. - ARIA-related symptoms, including edema and bleeding, primarily occur within the first six months of treatment, and patients with the ApoE4 allele are at higher risk for these complications [4]. Group 3: Market Context and Patient Demographics - Donanemab was recently introduced in China, but the long-term efficacy in the Chinese patient population is yet to be validated due to the timing of its market entry [4][5]. - The earlier launched drug, lecanemab, has also shown a 34% reduction in cognitive decline over four years, with no new safety issues reported, although this data does not include Chinese patients [5]. - China has approximately 9.83 million Alzheimer's patients, with an estimated 20% being in the early stages of the disease, indicating a significant potential market for innovative treatments [5].
礼来:记能达对早期症状性阿尔茨海默病显示出三年持续增强获益
Core Insights - Eli Lilly announced long-term extension results from its TRAILBLAZER-ALZ2 Phase 3 clinical study, showing significant disease progression slowdown in participants treated with donanemab compared to an untreated cohort from the Alzheimer's Disease Neuroimaging Initiative (ADNI) database [1] - The benefits of donanemab treatment continued to enhance over a three-year period, indicating sustained efficacy [1] - Participants who started treatment later still experienced benefits, but those who received early treatment had a significantly lower risk of progressing to the next stage of the disease compared to the delayed treatment group [1] - These findings were presented at the 2025 Alzheimer's Association International Conference (AAIC) held in Toronto [1]
多奈单抗注射液三年长期临床研究结果公布 创新疗法支持尽早干预
Zheng Quan Ri Bao Wang· 2025-08-02 01:41
Core Insights - The aging population in China is leading to an increased threat from Alzheimer's disease (AD), which has become the fifth leading cause of death in the country, following cardiovascular diseases, malignant tumors, chronic respiratory diseases, and diabetes [1] - There is a significant disease burden from Alzheimer's and other dementias in China, exceeding the global average, necessitating effective intervention measures to help patients capture the early intervention window [1] - Eli Lilly's TRAILBLAZER-ALZ2 long-term extension study results indicate that treatment with donanemab significantly slows disease progression, with benefits increasing over three years [1][2] Company Insights - Eli Lilly's TRAILBLAZER-ALZ2 study is a double-blind extension phase aimed at evaluating the long-term efficacy and safety of donanemab in early symptomatic Alzheimer's patients [2] - Participants originally receiving donanemab either continued treatment or switched to a placebo, while the placebo group began receiving donanemab under blind conditions [2] - The study included an external control group from the Alzheimer's Disease Neuroimaging Initiative (ADNI) to measure treatment outcomes [2] Study Results - Key preliminary results from the TRAILBLAZER-ALZ2 study show that participants receiving donanemab experienced sustained clinical benefits over three years, with a 0.6-point reduction in cognitive decline at 18 months and a 1.2-point reduction at 36 months on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) [3] - Early use of donanemab reduced the risk of disease progression to the next stage by 27% compared to delayed treatment [3] - Over 75% of participants treated with donanemab achieved amyloid clearance within 76 weeks, and the rate of amyloid plaque re-deposition remained slow at approximately 2.4 CL/year over a maximum observation period of 2.5 years [3] - No new safety signals were observed during the long-term extension phase, confirming the existing safety profile of donanemab [3]
特朗普政府政策转弯,考虑报销GLP-1类减肥药,礼来、诺和诺德股价上涨
美股IPO· 2025-08-01 23:51
拟议中的CMS计划将扩大覆盖范围,其中Medicaid的试点将于2026年4月启动,Medicare的试点计划则将于2027年1月开始。 诺和诺德的一位发言人拒绝对该试点计划置评,但表示: "通过政府和商业保险计划实现全面覆盖,对于实现可负担的医疗服务和治疗选择至关重要。" 这些药物在临床试验中已被证明可使体重减少15%至20%,年均费用为5000至7000美元,让人担心各州和联邦政府能否长期负担这些成本。 分析认 为,此举将标志着联邦政策的转变,此前特朗普政府在今年早些时候否决了一项拜登时代提出的将减肥药物纳入医保报销的提案。 Needham的分析师Ryan MacDonald表示,过去政府在这方面的重点是控制成本,限制覆盖范围。 "这确实像是一个重大政策立场的转变,至少在联邦医保(Medicare)方面是如此 。" 据媒体报道,目前有13个州已经为Medicaid患者报销这类药物,而Medicare则禁止为单纯用于减肥的药物提供报销,但允许用于治疗其他获批适应 症,如睡眠呼吸暂停和心脏病。 特朗普政府正考虑开展一项为期五年的医保试点计划,将包括Wegovy、Ozempic、Zepbound和Mounjar ...
隔夜美股 | 三大指数8月“开门黑”!市值蒸发逾万亿美元
智通财经网· 2025-08-01 23:07
智通财经APP获悉,周五,三大指数大幅收跌,市值蒸发逾1万亿美元,标普500指数连续第四个交易日 下滑。亚马逊市值单日蒸发超2000亿美元。此前数据显示,美国7月非农就业人口远低于市场预期,5月 和6月非农就业人数合计下修25.8万人。 【美股】截至收盘,道指跌542.40点,跌幅为1.23%,报43588.58点;纳指跌472.32点,跌幅为2.24%, 报20650.13点;标普500指数跌101.38点,跌幅为1.60%,报6238.01点。周五,美国科技股七巨头指数下 跌2.90%,报179.80点,本周累计下跌1.38%,微软(MSFT.US)业绩向好之际、7月31日曾高开至188.78 点。亚马逊(AMZN.US)收跌8.27%,Meta Platforms(META.US)跌3.03%,苹果(AAPL.US)跌2.50%,英伟 达(NVDA.US)跌2.33%,特斯拉(TSLA.US)跌1.83%,微软(MSFT.US)跌1.76%,谷歌 A(GOOG.US,GOOGL.US)跌1.44%。此外,台积电ADR(TSM.US)收跌2.65%,AMD(AMD.US)跌 2.64%,礼来(LLY.US ...
Cramer's week ahead: Earnings from Palantir, Berkshire Hathaway, Disney and McDonald's
CNBC· 2025-08-01 23:01
Group 1: Earnings Reports Overview - Palantir has secured a $10 billion Army contract and is expected to report strong quarterly results, with predictions of a "total blowout" due to strong business performance [2] - Berkshire Hathaway's upcoming earnings report is anticipated to be different under Greg Abel's leadership, with expectations of a potential stock price increase if results are favorable [1] - DuPont's breakup is on track, with expectations that the individual parts will be valued higher than the whole [3] Group 2: Sector Insights - Caterpillar is expected to post strong results, benefiting from domestic infrastructure and reshoring trends [3] - Eli Lilly's performance will be closely watched, especially in light of competitor Novo Nordisk's disappointing quarter, raising questions about market share dynamics in the GLP-1 drug sector [5] - Disney's shares have been climbing, with positive remarks on its streaming, theme park, and cruise line segments [4] Group 3: Other Companies to Watch - McDonald's is viewed as a buy due to recent improvements and new offerings [4] - Warner Bros Discovery is undergoing reorganization and debt reduction, with anticipation around its earnings report [6] - Pinterest is expected to deliver solid results, being recognized as a family-friendly advertising platform [6]
美股七巨头收盘播报|亚马逊市值单日蒸发超2000亿美元
Jin Rong Jie· 2025-08-01 20:59
周五,美国科技股七巨头指数下跌2.90%,报179.80点,本周累计下跌1.38%,微软业绩向好之际、7月 31日曾高开至188.78点。亚马逊收跌8.27%,Meta Platforms跌3.03%,苹果跌2.50%,英伟达跌2.33%, 特斯拉跌1.83%,微软跌1.76%,谷歌A跌1.44%。此外,台积电ADR收跌2.65%,AMD跌2.64%,巴菲 特旗下伯克希尔哈撒韦B类股则收涨0.20%,礼来制药涨3.01%。 本文源自:金融界AI电报 ...
Trim Your AI Stocks And Buy Eli Lilly
Seeking Alpha· 2025-08-01 19:18
Group 1 - Eli Lilly and Company (NYSE: LLY) has experienced a -5% decline in stock price since the last analysis, indicating potential market challenges ahead of Q2 earnings [1] - The analysis focuses on macro dynamics and rotational strategy, suggesting a need for investors to consider broader market trends and sector rotations [1] Group 2 - Invictus Origin, founded by Oliver Rodzianko, aims to deliver high annual returns through innovative portfolio strategies, particularly the High-Alpha Black Swan Portfolio [2] - The Invictus Hydra Portfolio maintains approximately 20% in dynamic cash reserves, allowing for strategic value investing during market disruptions [2] - Oliver Rodzianko has extensive experience as a macro-focused investment analyst, emphasizing fundamental valuation and sector expertise in technology, semiconductors, artificial intelligence, and energy [2]
美股异动 | 部分医药股上涨 礼来(LLY.US)涨超2%
智通财经网· 2025-08-01 14:44
智通财经APP获悉,周五,部分医药股上涨,截至发稿,礼来(LLY.US)、诺和诺德(NVO.US)涨超2%, 消息面上,特朗普政府正计划通过一项为期五年的试点项目,为部分医疗保险和医疗补助计划参保者提 供减肥药物费用报销。 ...
美医保拟覆盖礼来(LLY.US)诺和诺德(NVO.US)GLP-1减肥药,2026年起试点落地
智通财经网· 2025-08-01 13:12
行业趋势方面,GLP-1药物适应症持续扩展。例如美国食品药品管理局(FDA)已批准诺和诺德旗下的 Wegovy用于降低心血管疾病风险,礼来则进一步探索替尔泊肽在治疗睡眠呼吸暂停等新领域的潜力。 尽管政策试点尚未最终落地,但医保覆盖范围的扩大已被视为改变市场格局的关键变量。 项目将由CMS下属的医疗保险和医疗补助创新中心(CMMI)具体实施,其中医疗补助计划的覆盖预计于 2026年4月启动,医疗保险计划则定于2027年1月跟进。当被问及项目细节时,CMS发言人表示:"所有 药物纳入保险均需经过成本效益评估,CMS暂不对潜在模式或覆盖范围发表进一步评论。" 特朗普政府正计划通过一项为期五年的试点项目,为部分医疗保险和医疗补助计划参保者提供减肥药物 费用报销。此消息推动减肥药制造商礼来公司(LLY.US)和诺和诺德公司(NVO.US)周五盘前股价均上 涨。 根据美国医疗保险和医疗补助服务中心(CMS)披露的文件,各州医疗补助计划及医疗保险D部分计划可 自愿选择将诺和诺德旗下Ozempic、Wegovy,以及礼来公司旗下Mounjaro、Zepbound纳入保险覆盖范 围。该试点项目旨在缓解公众对广受欢迎的GLP-1 ...