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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 ...
通化金马:公司研制的化学1类新药琥珀八氢氨吖啶片已进入综合审评环节
Mei Ri Jing Ji Xin Wen· 2025-11-18 08:01
(记者 曾健辉) 通化金马(000766.SZ)11月18日在投资者互动平台表示,您好,我公司研制的化学1类新药琥珀八氢氨 吖啶片,已完成各项专业审评工作,进入综合审评环节,各项审评工作处于正常进行中。公司将继续深 度布局神经领域的产品管线和平台建设,有关新药的相关信息公司将根据有关规定和要求予以披露,请 投资者关注公司公告。 每经AI快讯,有投资者在投资者互动平台提问:尊敬的董秘您好!我们关注到公司的琥珀八氢氨吖啶 片是治疗阿尔茨海默病的重磅创新药。想请教,该药若成功上市,将如何具体支撑公司'中药亚洲化、 化药国际化'的战略目标?这是否意味着公司在中枢神经疾病领域的研发平台已成熟,未来该技术平台 是否会加速应用于其他管线的开发?谢谢! ...
温州医科大学×天津大学合作,开发阿尔茨海默病新疗法
生物世界· 2025-11-18 08:00
编辑丨王多鱼 排版丨水成文 撰文丨王聪 阿尔茨海默病 (AD) 是最常见的神经退行性疾病,目前尚无有效的治疗方法。细胞外淀粉样斑块、神经原纤维缠结、 神经炎症以及神经元丢失是阿尔茨海默病神经病理学的特征。 β- 淀粉样蛋白 (Aβ) 是淀粉样斑块的主要成分,它是通过 β-分泌酶 BACE1 和 γ-分泌酶对 淀粉样前体蛋白 (APP) 进行连续切割而产生的。 APP、BACE1 和 γ-分泌酶的失调会增加 Aβ 的生成,而小胶质细胞的功能障碍会 降低对 Aβ 的清除,从而导致 Aβ 的沉积。Aβ 沉积的增加反过来会激活小胶质细胞,促进大量促炎细胞因子的分泌。 肠道微生物群及其代谢物的失调在阿尔茨海默病 (AD) 的发病机制中发挥着关键作用。 丁酸 (Butyrate) 是一种短 链脂肪酸 (SCFA) ,主要由肠道细菌通过膳食纤维的发酵产生,具有多种生理功能,包括调节肠道健康、抗炎和神经 保护作用。近年来,研究发现丁酸在大脑健康及神经退行性疾病 (例如阿尔茨海默病) 中可能发挥有益作用。 提高丁 酸的生物利用度,对于其临床应用至关重要。 2025 年 11 月 17 日,温州医科大学/瓯江实验室 吴伊丽 教授 ...
Alpha Cognition Inc(ACOG) - 2025 Q3 - Earnings Call Transcript
2025-11-13 22:30
Alpha Cognition (NasdaqCM:ACOG) Q3 2025 Earnings Call November 13, 2025 04:30 PM ET Speaker5Greetings. Welcome to Alpha Cognition's earnings conference call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Henry Du, Interim CFO. Tha ...
石家庄以岭药业股份有限公司关于收到化学原料药上市申请批准通知书的公告
Core Viewpoint - Shijiazhuang Yiling Pharmaceutical Co., Ltd. has received approval for the listing application of Memantine Hydrochloride, a chemical raw material drug, which is expected to enhance the company's product line and market share in the Alzheimer's treatment sector [1][2]. Group 1: Approval Notification - The approval notification was issued by the National Medical Products Administration for the chemical raw material drug Memantine Hydrochloride, submitted by the company's wholly-owned subsidiary, Hengtai Wanyuan Pharmaceutical Co., Ltd. [1] - The registration number for the drug is Y20240000483, confirming that it meets the requirements for drug registration under Chinese law [1]. Group 2: Drug Overview - Memantine Hydrochloride is a non-competitive NMDA receptor antagonist used to treat moderate to severe Alzheimer's disease, blocking neuronal damage caused by elevated glutamate levels [2]. - According to the 2024 China Alzheimer's Disease Report, there are approximately 16.9 million dementia patients in China, with a prevalence rate of about 1.19% [2]. - The anti-dementia market in China is valued at 1.56 billion yuan, with Memantine being a first-line treatment drug holding a market share of 22% [2]. - The market capacity for Memantine Hydrochloride in China is expected to reach 340 million yuan by 2025, with a year-on-year growth of 11% [2]. Group 3: Impact on the Company - The approval of Memantine Hydrochloride allows the company to sell the drug in the domestic market, enriching its product line and expanding its business scope [3]. - Currently, the approval is not expected to have a significant impact on the company's immediate operating performance [3].
以岭药业“盐酸美金刚”原料药上市获批
Zheng Quan Shi Bao· 2025-11-12 18:32
Group 1 - Yiling Pharmaceutical's subsidiary Hengshui Wanyang received approval from the National Medical Products Administration for the listing application of Memantine Hydrochloride, a drug used to treat moderate to severe Alzheimer's disease [1] - Memantine Hydrochloride is a non-competitive NMDA receptor antagonist that blocks pathological increases in glutamate concentration, preventing neuronal damage [1] - The Alzheimer's disease report of 2024 indicates approximately 16.9 million dementia patients in China, with a prevalence rate of about 1.19‰, which is rapidly increasing due to population aging [1] Group 2 - The anti-dementia market in China is valued at 1.56 billion yuan, with Memantine being a first-line treatment drug holding a market share of 22% [1] - The market capacity for Memantine Hydrochloride in China is expected to reach 340 million yuan by 2025, with a year-on-year growth of 11%, and sales volume projected to be 160 million tablets, reflecting a 19% increase [1] - Yiling Pharmaceutical aims to enhance its market share following the domestic approval of Memantine Hydrochloride, anticipating steady demand growth due to the aging population [1] Group 3 - Yiling Pharmaceutical also received approval for Anastrozole, a drug widely used for treating estrogen-related tumors, just days prior [2] - The company’s subsidiary Beijing Yiling Bio holds the formulation approval for Anastrozole tablets, which are expected to achieve integrated production of raw materials and formulations this year, enhancing market competitiveness [2] - Yiling Pharmaceutical plans to accelerate the international registration and overseas sales of Anastrozole raw materials, targeting markets in Europe and the United States [2]
恩瑞特药业阿尔茨海默病新药获批上市;热景生物拟斥1亿元~2亿元回购股份丨医药早参
Mei Ri Jing Ji Xin Wen· 2025-11-11 23:26
Group 1 - Huzhou Bio plans to repurchase shares worth 100 million to 200 million yuan, using its own funds, to stabilize stock prices and incentivize core talent [1] - The repurchase will cover 409,837 to 819,672 shares, accounting for 0.44% to 0.88% of the total share capital, and will be completed within 12 months [1] Group 2 - Enrite Pharmaceuticals' new drug, Memantine Hydrochloride Orally Disintegrating Tablets, has been approved for the treatment of moderate to severe Alzheimer's disease [2] - This drug is a novel NMDA receptor antagonist that protects nerve cells and promotes cognitive function recovery, filling a gap in the domestic market for this dosage form [2] Group 3 - Novartis' Remibrutinib has received FDA approval for treating adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic after H1 antihistamine treatment [3] - Remibrutinib is the first BTK inhibitor approved by the FDA for CSU, providing a new treatment option by targeting the BTK signaling pathway to inhibit the release of histamine and other pro-inflammatory mediators [3]