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].

Core Viewpoint - The prescription drug GV-971 (brand name "Jiuyiqi") for Alzheimer's disease has been discontinued, leading to a significant price increase and supply shortages, raising concerns about the company's future and the drug's efficacy [1][3][4]. Group 1: Company Situation - Green Valley Pharmaceutical Technology is facing severe cash flow issues, having notified all employees of a three-month leave starting in June, with salaries reduced to 2,600 yuan per month [3][4]. - The company has indicated that the drug's production halt is due to the expiration of its drug registration certificate, with new approvals pending [5][6]. - There have been over 9,300 patient requests for the drug, and more than 1,200 doctors have urged the company to ensure the supply of GV-971 [6][7]. Group 2: Drug Efficacy and Controversy - GV-971 has been subject to academic controversy, with former president of Capital Medical University, Rao Yi, questioning the authenticity of the research and the drug's effectiveness, alleging research misconduct [4][8]. - The drug was conditionally approved by the National Medical Products Administration in November 2019, and it was included in the medical insurance list in 2021 at a price of 296 yuan per box [4][7]. - Despite the controversies, the company claims that the drug has shown improvements in cognitive function in patients during clinical studies, with results expected to be presented at international academic conferences [7][10]. Group 3: Market Dynamics - The price of GV-971 has surged to between 830 yuan and 1,033 yuan per box due to supply shortages, compared to its original price of 296 yuan [1][4]. - The drug has sold 2.13 million boxes in 2024 alone, indicating a significant market presence despite the ongoing controversies [4][11]. - The approval process for new drugs in the Alzheimer's treatment space is generally slow, with industry insiders suggesting that the ongoing efficacy debates may be contributing to the delays in GV-971's new registration [6][8].