Lecanemab

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NKGen Biotech Administers First Dose of Troculeucel to Alzheimer's Patient Who Continued to Decline Cognitively While on Prior Amyloid-Targeting Therapy
Globenewswire· 2025-07-10 20:30
SANTA ANA, Calif., July 10, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (OTC: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, today announced the administration of the first dose of troculeucel, an expanded autologous NK cell therapy, under a single compassionate use, Investigational New Drug (“IND”) authorization cleared by the U.S. Food and Drug Admini ...
美国加征药品和铜关税,推动战略物资自给
日经中文网· 2025-07-10 07:10
Group 1 - The U.S. announced a 200% tariff on imported pharmaceuticals and a 50% tariff on copper and related products, aiming to boost domestic production and supply chain adjustments [1][2] - The pharmaceutical import value for the U.S. is projected to reach $246.8 billion in 2024, accounting for 7.6% of total imports, with the U.S. pharmaceutical market size expected to be $797.8 billion, representing over 40% of the global market [1] - Major pharmaceutical companies like Merck and Novartis are planning investments in response to the tariffs, with a total of $166 billion in new investments announced by six well-known companies since 2025 [1] Group 2 - Japan's pharmaceutical exports to the U.S. are projected to be 411.4 billion yen in 2024, making up 1.9% of total exports to the U.S., with companies like Takeda planning to invest $30 billion in the U.S. over the next five years [2] - Takeda's U.S. operations account for half of its consolidated sales, and the company is implementing measures to manage the impact of tariffs on imported products [2] - The unexpected high tariff on copper led to a 17% increase in copper futures prices, reaching approximately $13,000 per ton, marking a historical high [2][3] Group 3 - The U.S. is heavily reliant on copper imports, with over 40% of its consumption expected to come from abroad in 2024, and plans to increase domestic production by 70% by 2035 to reduce import dependency to 30% [3] - The high copper tariffs are seen as a strategic move considering China's position as a major copper producer, with Chile being the largest source of U.S. copper imports [4] - There are discussions about the potential impact of tariffs on U.S. investments in South American copper mines, which are partly funded by Japanese companies [4]
绿谷制药回应阿尔茨海默病药物GV-971停产断供问题
Guo Ji Jin Rong Bao· 2025-06-11 06:43
此外,还有消息称,因药品注册许可证已到期,但新的审批证尚未通过,绿谷医药科技可能要关闭九期一相关办公区、生产厂区。另据《第一财经》独家报 道,绿谷医药科技因现金流极度紧张,已通知全体员工从6月起放假三个月,每月工资降至2600元。 争议较大,新证卡壳 近日,治疗阿尔茨海默病(AD)的处方药甘露特钠胶囊(GV-971,商品名"九期一")停产的消息不断。《国际金融报》记者在网络销售渠道注意到,150mg*42 粒/盒的甘露特钠胶囊价格已经涨到了830元-1033元/盒(原价为296元/盒),且商品大多显示"已卖光"。 对此,该公司表示,"公司并未收到质量或药效等不良反馈问题。"并进一步提供资料称,甘露特钠的两项上市后临床研究GV-971-PMS-A和GV-971-PMS-B针 对其长期安全性和有效性在3300例患者中进行了为期2年的观察。初步中期分析显示,阿尔茨海默病初治患者在使用甘露特钠单药治疗(单方)1年时,其认知 功能和日常生活能力均获得基线以上的改善(逆转)。其终期数据结果计划今年下半年于相关国际学术会议公布和解读。迄今,甘露特钠已获11个诊疗规范、 权威指南、共识等推荐。" 各种传言不断,导致九期一断供 ...
5月15日电,日本卫材和渤健将把仑卡奈单抗 (Lecanemab)的部分产能迁移到美国。
news flash· 2025-05-14 22:09
智通财经5月15日电,日本卫材和渤健将把仑卡奈单抗 (Lecanemab)的部分产能迁移到美国。 ...
第三大疾病市场,遭巨头放弃
Xin Lang Cai Jing· 2025-05-07 16:26
节前,阿斯利康在Q1财报会上高调宣布,将全面退出CNS(中枢神经)领域,终止多个管线项目。 这是继阿斯利康提出"800亿美元"收入目标后的第一次大的管线战略抉择。 消息一出,也引起全行业的巨震。毕竟,同时停掉一整个治疗领域是需要相当大的决心的,这意味着大 量的研发投入打水漂,钱是小事,重要的是巨大的时间成本。 阿斯利康的选择很好理解:CNS领域产品开发难度比想象中要高,而为了尽快实现800亿目标,公司只 能在短期去找确定高的大品种去卷执行能力(比如减肥药和ADC),短中期的高KPI压力,逼着公司很 难去从长期考虑CNS这种"潜在回报巨大,但投入周期漫长"的方向。 CNS领域这几年发展可谓是"喜忧参半"。喜在以礼来、渤健以及福泰等公司在机理和产品获批上均实现 部分突破。"忧"这一块,除了阿斯利康,安进、辉瑞、赛诺菲等在此前均放弃该领域产品开发。 而前年艾伯维87亿天价收购的Cerevel Therapeutics约莫重新燃起了CNS领域的热度,如今,其核心用于 治疗精神分裂症的产品Emraclidine,也在两项二期临床中宣告失败。 大厂们的选择是一个"超级风向标"。那么对于国内这些本土CNS龙头,其中不乏恩华 ...
Leqembi®∇ (lecanemab) is the First Medicine that Slows Progression of Early Alzheimer's Disease to be Authorized in the European Union
Newsfilter· 2025-04-15 23:00
Core Insights - Lecanemab has received Marketing Authorization in the EU, marking it as the first therapy targeting the underlying cause of Alzheimer's disease to be approved in this region [1][2] - The treatment is specifically indicated for adult patients with mild cognitive impairment and mild dementia due to Alzheimer's disease who are ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology [1][2] - The approval applies to all 27 EU Member States, as well as Iceland, Liechtenstein, and Norway [1][3] Company Overview - Eisai Co., Ltd. and Biogen Inc. are collaborating on the development and commercialization of lecanemab, with Eisai leading the global development and regulatory submissions [2][8] - The approval of lecanemab in the EU is the thirteenth approval globally, following its benefits to thousands of patients in the U.S., Japan, and other regions [2][6] - Eisai aims to work with national reimbursement authorities and healthcare providers to ensure access to lecanemab for eligible patients as soon as possible [2] Clinical Data - The authorization was based on Phase 3 data from the Clarity AD clinical trial, which involved 1,795 patients with early Alzheimer's disease [4][6] - In the trial, lecanemab reduced clinical decline on the CDR-SB scale by 31% at 18 months compared to placebo [4][6] - The secondary endpoint showed a 33% less decline in daily living activities for patients treated with lecanemab compared to placebo [4][6] Market Context - Alzheimer's disease currently affects an estimated 15.2 million people with mild cognitive impairment and 6.9 million with mild dementia in Europe, indicating a significant unmet need for effective treatments [1][6] - Lecanemab is the only approved Aβ monoclonal antibody that preferentially binds and clears toxic protofibrils, which are key contributors to neuronal injury in Alzheimer's disease [1][4] - The approval of lecanemab represents a landmark advancement in a field that has seen little innovation over the past two decades [2][6]