探访 | 这款国产“老年痴呆”知名药停产 投资12亿元的新厂也空置了

Core Viewpoint - The Chinese innovative drug "Jiuqi Yi" (GV-971) developed by Green Valley (Shanghai) Pharmaceutical Technology Co., Ltd. is facing production suspension due to the expiration of its drug registration certificate and delays in renewal approval, amidst rising investment enthusiasm in China's innovative drug sector [1][4][15]. Group 1: Company Situation - Green Valley announced that as of May 30, 2025, relevant positions for "Jiuqi Yi" have been suspended, with the main reason being the expiration of the drug registration certificate on November 2, 2024, and the failure to complete the renewal process on time [1][4]. - The company has been actively communicating with regulatory authorities regarding the renewal application, which was submitted on October 25, 2024, and is currently in a "waiting for review" status [4][5]. - Green Valley confirmed that the temporary adjustment only affects the "Jiuqi Yi" product line, and employees will receive wages at the minimum wage standard while social security and housing funds will continue to be paid [1][4]. Group 2: Product and Market Context - "Jiuqi Yi" was approved for conditional marketing in November 2019 and is recognized as the first drug targeting Alzheimer's disease in over 16 years, with a sales price of 296 yuan per box [15][16]. - Since its launch, "Jiuqi Yi" has sold 2.13 million boxes and benefited over 500,000 patients [16]. - The drug has faced ongoing academic controversy regarding its efficacy and safety, with critics questioning its mechanism of action and the adequacy of clinical trial durations [17][19]. Group 3: Clinical Research and Efficacy - Green Valley has conducted two post-marketing clinical studies involving 3,300 patients over approximately two years, showing improvements in cognitive function and daily living abilities for initial treatment patients [4][5]. - The company plans to present final data results from these studies at international academic conferences later this year [5]. - Despite the controversies, Green Valley maintains that it has not received negative feedback regarding the quality or efficacy of "Jiuqi Yi" [4][5].