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国内开启最大规模阿尔茨海默病注册研究 已完成50例受试者入组
阿尔茨海默病(俗称"老年痴呆症")的治疗是一项世界性难题,但全球医学界的探索从未止步。日前, 国内最大规模阿尔茨海默病注册研究正式开启。 在今日公告中,万邦德还指出,石杉碱甲是用于改善认知功能的胆碱酯酶抑制剂,临床前研究展现出延 缓阿尔茨海默病疾病进展的潜力及广泛的综合获益,包括对β淀粉样蛋白的降低作用,抗炎、抗氧化应 激以及神经元保护作用,有望成为具有广谱抗阿尔茨海默病型痴呆的药物。 据了解,石杉碱甲控释片是万邦德自主研发的用于治疗轻、中度阿尔茨海默病型痴呆的2.2类新药,采 用双相控释技术,平缓药物释放峰谷曲线,并延长药物体内释放时间,从而实现快速起效,减少不良反 应,提升给药剂量与良好的安全性。同时,控释技术支持每天一次给药,提高患者的用药便利性和长期 依从性。 另外,万邦德还表示,此次开展的II/III期临床研究,是中国目前已知规模最大的阿尔茨海默病注册研 究。公司积极推进受试者入组,公司将继续与首都医科大学宣武医院等全国50多家研究机构紧密合作, 进一步验证药物的安全性、有效性,为产品的最终上市申请提供关键数据支撑。 据悉,万邦德办公地浙江台州,是我国原料药的生产重地,涌现出了一批知名药企。其中,万 ...
年费超10万的老年痴呆症新药,首次进商保
(原标题:年费超10万的老年痴呆症新药,首次进商保) 无论是卫材公司的仑卡奈单抗还是礼来的多奈单抗,患者一年的治疗费用均需超过10万元。高昂的治疗 费用一度让不少阿尔茨海默病(AD)患者家庭在希望与绝望间徘徊,直到首版商保创新药目录为这种 困境带来了转机。 日前,在2025创新药高质量发展大会上,我国首版《商业健康保险创新药品目录》正式发布。两款近年 来最具突破性的阿尔茨海默病对因治疗药物——仑卡奈单抗注射液和多奈单抗注射液双双入选。而被纳 入商保目录的两款AD药物,都代表了当前阿尔茨海默病治疗领域的最高水平。 AD,作为老龄化社会中的"沉默杀手",国内患者数量已超1000万。然而,过去由于药物疗效有限且价 格高昂,其临床使用率一直极低。眼下,商保目录意味着,政策在破局。在商保目录推动下, 全球阿 尔茨海默病治疗市场正在经历一场深刻变革。 ...
年耗数十万!阿尔茨海默病新药入商保 能否破解“记忆困境”?
复旦大学公共卫生学院副院长、复旦大学医学技术评估研究中心教授陈英耀表示:"对于创新药物和疗 法,国家政策是鼓励为有价值的创新买单。多层次医疗保障体系建设的工作持续推进,商业健康保险也 为创新药支付提供了更丰富和多元的支持路径。" 这也映射着我国多层次医疗保障体系在创新药可及性领域迈出的重要一步。自今年起,国家医保部门首 次探索"商业健康保险"联动医保目录机制,聚焦创新程度高、临床价值大、患者获益显著的药物,旨在 通过医保与商业险的协同发力,进一步提高人民群众对重大疾病创新疗法的可负担性和可及性。 无论是卫材公司的仑卡奈单抗还是礼来的多奈单抗,患者一年的治疗费用均需超过10万元。高昂的治疗 费用一度让不少阿尔茨海默病(AD)患者家庭在希望与绝望间徘徊,直到首版商保创新药目录为这种 困境带来了转机。 日前,在2025创新药高质量发展大会上,我国首版《商业健康保险创新药品目录》正式发布。两款近年 来最具突破性的阿尔茨海默病对因治疗药物——仑卡奈单抗注射液和多奈单抗注射液双双入选。 有券商医药行业分析师也对21世纪经济报道记者指出,此次多奈单抗(记能达®)、仑卡奈单抗(乐意 保®)纳入首版商业保险创新药目录,标志着A ...
年费超10万的老年痴呆症新药,首次进商保,超1000万患者减负
无论是卫材公司的仑卡奈单抗还是礼来的多奈单抗,患者一年的治疗费用均需超过10万元。高昂的治疗 费用一度让不少阿尔茨海默病(AD)患者家庭在希望与绝望间徘徊,直到首版商保创新药目录为这种 困境带来了转机。 日前,在2025创新药高质量发展大会上,我国首版《商业健康保险创新药品目录》正式发布。两款近年 来最具突破性的阿尔茨海默病对因治疗药物——仑卡奈单抗注射液和多奈单抗注射液双双入选。 复旦大学公共卫生学院副院长、复旦大学医学技术评估研究中心教授陈英耀表示:"对于创新药物和疗 法,国家政策是鼓励为有价值的创新买单。多层次医疗保障体系建设的工作持续推进,商业健康保险也 为创新药支付提供了更丰富和多元的支持路径。" 这也映射着我国多层次医疗保障体系在创新药可及性领域迈出的重要一步。自今年起,国家医保部门首 次探索"商业健康保险"联动医保目录机制,聚焦创新程度高、临床价值大、患者获益显著的药物,旨在 通过医保与商业险的协同发力,进一步提高人民群众对重大疾病创新疗法的可负担性和可及性。 面对医保目录"保基本"的定位与突破性创新药高昂价格之间的矛盾,国家医保局作出了制度性回应。 今年6月30日,国家医保局会同国家卫生健康委 ...
年费超10万的老年痴呆症新药,首次进商保,超1000万患者减负
21世纪经济报道· 2025-12-09 02:34
Core Viewpoint - The inclusion of innovative Alzheimer's disease (AD) treatments, Lecanemab and Donanemab, in China's first commercial health insurance innovative drug directory marks a significant breakthrough in the payment model for high-cost treatments, transitioning from a single reliance on public insurance to a "public + commercial" layered payment system [2][6][10]. Group 1: Policy and Market Impact - The release of the first commercial health insurance innovative drug directory at the 2025 Innovative Drug High-Quality Development Conference includes two groundbreaking AD treatments, reflecting a critical step in enhancing the accessibility of innovative drugs within China's multi-tiered healthcare system [1][6]. - The new policy aims to alleviate the financial burden on patients by leveraging the flexibility of commercial insurance, which can provide customized coverage and complement public insurance, thereby reducing out-of-pocket expenses for patients [4][6]. - The commercial insurance directory includes 19 drugs, with a focus on high-innovation and high-clinical-value treatments, indicating a shift in the healthcare landscape towards supporting innovative therapies [6][10]. Group 2: Economic and Social Implications - The economic burden of AD in China is substantial, with annual costs for patients reaching approximately 1.1 trillion RMB in 2015, projected to rise to 3.2 trillion RMB by 2030 and 11.9 trillion RMB by 2050, highlighting the urgent need for effective treatment options [9][10]. - The low early diagnosis rate of AD in China, with 95% of patients diagnosed at moderate to severe stages, underscores the necessity for improved screening and treatment protocols to enhance early intervention [8][9]. - The introduction of the commercial insurance directory is expected to stimulate demand for AD treatments, promoting early diagnosis and standardized treatment practices, which are essential for addressing the public health challenges posed by an aging population [4][10]. Group 3: Research and Development Landscape - The development of new AD drugs is a lengthy and costly process, averaging 10.5 years and requiring approximately 2.6 billion USD, with many candidates failing at various stages of clinical trials [12][14]. - Despite the challenges, the competitive landscape for AD treatments is evolving, with domestic companies rapidly advancing their research efforts, while international firms continue to seek market entry in China [15][16]. - The recent failures of major pharmaceutical companies in clinical trials have not deterred investment in AD research; instead, they have accelerated the transformation of the AD treatment ecosystem, shifting focus from mere drug competition to a broader ecological competition [14][15].
ProMIS Neurosciences (NasdaqCM:PMN) FY Conference Transcript
2025-12-02 21:27
ProMIS Neurosciences (NasdaqCM:PMN) FY Conference December 02, 2025 03:25 PM ET Company ParticipantsNeil Warma - CEOConference Call ParticipantsNone - AnalystNoneOf hosting Neil Warma, CEO of ProMIS Neurosciences. Neil, welcome. Thank you so much for making the trek down here to sunny Miami to be with us. But before we delve into Q&A, I would love to hear the state of the business, key data points to look out for the next 12 months or so.Neil WarmaSure. Well, thanks, Michael. And thanks to the organizers fo ...
礼来阿尔茨海默病新药记能达 在华更新剂量方案
Jing Ji Guan Cha Wang· 2025-11-24 09:52
礼来中国总经理德赫兰表示,此次更新在保障疗效的同时显著提升了安全性,是阿尔茨海默病治疗的重 要进展。此举旨在为中国早期症状性阿尔茨海默病患者提供更安全、可控的治疗选择,推动疾病进入长 程管理的新时代。 经济观察网礼来公司宣布,其每月一次的阿尔茨海默病治疗药物记能达(多奈单抗)已获中国国家药监局 批准更新说明书,采纳新的推荐剂量滴定方案。该新方案采用更渐进的滴定方式。关键临床研究 (TRAILBLAZER-ALZ6)数据显示,新方案在第24周和第52周,能将淀粉样蛋白相关性影像异常(ARIA- E,一种常见副作用)的发生率分别显著降低41%和35%,同时保持了与原方案相当的淀粉样蛋白斑块清 除效果。 ...
构建适老化产品矩阵,西点药业引进阿尔兹海默症仿制药
Cai Jing Wang· 2025-11-21 06:56
Core Viewpoint - West Point Pharmaceutical has announced that its oral solution of Rivastigmine Tartrate for the treatment of mild to moderate Alzheimer's disease will be launched in 2025, aiming to capture long-term opportunities arising from an aging population [1][2]. Group 1: Company Strategy and Product Development - The company is focusing on the "silver economy" strategy, which includes introducing new products and redeveloping existing ones, with a capitalized cooperation model with Shandong Langnuo Pharmaceutical for Rivastigmine Tartrate [2][4]. - West Point Pharmaceutical aims to build a product matrix for elderly care, targeting chronic diseases prevalent among the elderly, and enhancing product development efficiency through strategic partnerships [4][5]. Group 2: Financial Performance - Since its listing in February 2022, West Point Pharmaceutical has shown lackluster performance, with a revenue of 256 million yuan in 2024, a year-on-year increase of 13.71%, but a net profit decline of 20.26% to 40 million yuan [3]. - For the first nine months of 2025, the company reported a revenue of 189 million yuan, a decrease of 1.89%, and a net profit of 33 million yuan, down 2.70% year-on-year [4]. Group 3: Product Details and Market Context - Rivastigmine Tartrate, initially developed by Novartis, is a third-generation acetylcholinesterase inhibitor used for treating Alzheimer's disease, first launched in Switzerland in 1997 and approved in China in 2000 [8][9]. - The drug is currently one of the most effective treatments for Alzheimer's, but its market price is high, with domestic production by multiple companies including Shandong Langnuo and Zhejiang Kairun [11][14].
北京大学最新Cell论文:开发出阿尔茨海默病新疗法
生物世界· 2025-11-21 00:08
撰文丨王聪 编辑丨王多鱼 排版丨水成文 学习 通常指知识的获取, 记忆 则是保留信息的能力,这两项是人类大脑的基本功能,受特定脑区神经递质/神经肽信号的调控。这些神经递质/神经肽的耗竭或 其受体表达的减少,尤其是在老年人中,可能会导致记忆障碍。 胆囊收缩素 (CCK) 是大脑中含量最丰富的神经肽之一,分布于新皮质、杏仁核、丘脑、海马体和内嗅皮质 (EC) 。CCK 参与神经递质传递,并调控许多大 脑功能,如情绪、学习和记忆、焦虑以及恐惧。重要的是,内嗅皮层是富含 CCK 的大脑区域,它充当海马体与新皮质之间信息传递的中介。 CCK 通过与 B 型 胆囊收缩素受体 (CCKBR) 的特异性结合发挥核心作用, 这一作用不仅对长时程增强 (LTP) 至关重要, 并对于声音 - 声音联想记忆也很重要,这是学习和 记忆的一个重要方面。 然而,大脑中有多种 CCK 亚型,它们能够激活多种 G 蛋白亚型信号,包括但不限于 Gs、Gq 和 Gi,其中 硫酸化 CCK8 (CCK8s) 最为丰富。此前的研究显 示,外源性 CCK8s 能够显著改善老年大鼠的空间学习记忆能力,这提示了 调控 CCK 信号通路 有治疗阿尔茨海默病的 ...
Eli Lilly gets drug regulator nod for Alzheimer's disease medication
BusinessLine· 2025-11-18 09:50
Eli Lilly and Company (India) on Tuesday said it has received approval from national drug regulator CDSCO for a drug to treat Alzheimer's disease. The company has received marketing authorisation from the Central Drugs Standard Control Organization (CDSCO) for donanemab (350 mg/20 mL), administered every four weeks via intravenous infusion, for the treatment of Alzheimer's disease in adults with early symptomatic stages. This includes individuals with mild cognitive impairment and those in the mild dementia ...