阿尔茨海默病“传奇”药物突遭停产，药企公开回应资金链危机

Core Viewpoint - The news highlights the supply issues surrounding GV-971 (甘露特钠胶囊), a drug for Alzheimer's disease, which has led to a significant price increase and potential production halt due to regulatory challenges and cash flow problems faced by the manufacturer,绿谷制药 [1][3][5]. Group 1: Supply and Demand - GV-971 has been experiencing a supply shortage since six months ago, with recent reports indicating complete stockouts, causing prices to surge from 296 yuan to between 830 yuan and 1,033 yuan per box [1]. - Over 9,300 patients have requested the drug, and more than 1,200 doctors have urged the company to ensure continuous supply [1]. - The company is in communication with relevant authorities to expedite the review process for the drug's certification renewal [1][2]. Group 2: Regulatory and Clinical Background - GV-971 was conditionally approved in November 2019, becoming the first drug targeting the "gut-brain axis" mechanism for Alzheimer's treatment [3]. - The drug's approval was contingent upon the submission of long-term carcinogenicity data, which was completed and submitted in December 2019, showing no carcinogenic risk [3]. - The drug has been under review since October 2024, but its approval status remains pending, possibly due to ongoing debates regarding its efficacy [4]. Group 3: Financial Performance and Market Impact - Since its launch, GV-971 has reportedly benefited over 500,000 patients, with sales reaching 2.13 million boxes in 2024 alone [5]. - The drug's sales have grown at a compound annual growth rate of 343.2% since its approval, with hospital sales reaching 170 million yuan and retail sales at 156 million yuan in 2022 [5]. - The company has faced severe cash flow issues, leading to temporary layoffs and reduced salaries for employees [2]. Group 4: Alternative Treatments and Market Landscape - Despite the supply issues with GV-971, other established treatments for Alzheimer's disease, such as cholinesterase inhibitors and NMDA receptor antagonists, remain available [6]. - Newer drugs like Eli Lilly's donanemab and Eisai's lecanemab have also entered the market, providing additional options for patients [7]. - The Alzheimer's drug development landscape is characterized by high investment and risk, with over $100 billion invested globally, yet only one drug successfully launched from over 200 clinical trials [8][9].