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阿尔茨海默病治疗药物研发
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上海复星医药(集团)股份有限公司关于控股子公司签订许可协议的公告
Core Viewpoint - The announcement details a licensing agreement between Fosun Pharma and NewCo for the development, registration, production, and commercialization of the drug AR1001, aimed at treating Alzheimer's disease and other neurological disorders in China and Hong Kong [2][4][20]. Group 1: Agreement Overview - The agreement allows Fosun Pharma's subsidiary to develop and commercialize AR1001, which is currently undergoing Phase III clinical trials globally, including in China [7][8]. - The licensing agreement does not require approval from the company's board or shareholders [5]. - The agreement is not classified as a related party transaction [6]. Group 2: Product Details - AR1001 is an oral drug designed to slow the progression of Alzheimer's disease, with strong PDE-5 inhibition properties [7]. - Clinical trials have shown that AR1001 can clear amyloid plaques associated with Alzheimer's and has potential therapeutic effects for early-stage patients [7]. Group 3: Financial Terms - Fosun Pharma will pay up to RMB 150 million (approximately $22 million) to NewCo, including an upfront payment of RMB 40 million and milestone payments based on regulatory progress [12]. - For localized products, Fosun Pharma will pay a tiered sales milestone based on annual net sales, with a low double-digit percentage sales share to NewCo [12]. Group 4: Strategic Impact - This collaboration aims to enhance Fosun Pharma's product pipeline in the central nervous system field, improving its market position and competitiveness in treating Alzheimer's and other neurological diseases [20].
“神药”突然被爆停产,多地断货!办公区、生产区将关闭,有药房一度标出5000元/盒“天价”
21世纪经济报道· 2025-06-09 12:08
Core Viewpoint - The production of GV-971 (Mannoheptulose Sodium Capsules), a drug for Alzheimer's disease, has been halted by Green Valley Pharmaceutical, leading to supply shortages and rising prices, raising concerns among patients and families [2][11]. Group 1: Company Situation - Green Valley Pharmaceutical confirmed the closure of offices and production areas related to GV-971 on June 8, 2023, amid severe operational pressures and cash flow issues [2][4]. - The company previously announced on May 19, 2023, that it was aware of the difficulties patients faced in obtaining the drug and was working with authorities to resolve supply issues, but this announcement was deleted shortly after [2][4]. - The drug has faced ongoing academic controversy since its launch in 2019, with questions regarding its mechanism of action and clinical efficacy [4][10]. Group 2: Market Impact - Patients across multiple cities, including Guangzhou, Beijing, and Shanghai, reported difficulties in obtaining GV-971, with prices increasing significantly from around 296 yuan per box (the price when included in medical insurance) to between 500 and 600 yuan, and in some cases, even reaching 5000 yuan [7][11]. - Online platforms have seen a drastic reduction in available stock, with only a few pharmacies listing the drug for sale, often with purchase limits [7][8]. Group 3: Drug Efficacy and Alternatives - The mechanism of GV-971 involves modulating beneficial gut bacteria and related metabolites, which may alleviate neuroinflammation and reduce Alzheimer's-related protein production [9]. - There are currently no other drugs with a similar mechanism approved, but alternative symptomatic treatments are available, including cognitive training and emotional regulation [9][14]. - The drug's conditional approval in 2019 required further clinical trials, which have faced delays, including the suspension of international Phase III trials in 2022 due to various factors [11][12].