Core Viewpoint - The domestic Alzheimer's drug, Ganluo Sodium, developed by Green Valley Pharmaceutical, has faced regulatory challenges, failing to obtain re-registration approval from the National Medical Products Administration (NMPA) [2][11]. Regulatory Status - On August 12, the NMPA issued a notification regarding Ganluo Sodium, indicating that it did not receive a corresponding approval number, suggesting that the drug did not gain re-registration approval [2]. - Ganluo Sodium's registration certificate expired after five years, necessitating a new application for market approval, which Green Valley submitted in 2024 [2][5]. Product Background - Ganluo Sodium, also known as "Jiuyiqi" or "971," is the first domestically developed innovative drug for Alzheimer's disease, conditionally approved for market entry in November 2019 [2][4]. - The drug is derived from algae and targets the gut-brain axis to improve cognitive function by reshaping gut microbiota and reducing neuroinflammation [5]. Controversies and Challenges - The drug has been controversial since its launch, with debates surrounding its mechanism of action and the reliability of its clinical trials, particularly the shortened duration of its Phase III trials [6]. - Following the conditional approval, the NMPA required Green Valley to continue research on the drug's pharmacological mechanisms and long-term safety and efficacy [6]. Market Impact - Reports of drug shortages began in early 2023, leading to public outcry as patients faced difficulties obtaining Ganluo Sodium [7][8]. - The price of Ganluo Sodium surged on e-commerce platforms, with some listings reaching up to 5,000 yuan per box due to supply issues [8]. Patient Perspective - Despite criticisms, many patients and their families reported that Ganluo Sodium was effective, highlighting the lack of alternative affordable treatments for Alzheimer's [9]. - The drug was included in the national medical insurance directory, significantly reducing its price from 895 yuan to 296 yuan per box, making it a more accessible option compared to newer drugs costing 200,000 to 300,000 yuan annually [9]. Future Outlook - With the expiration of Ganluo Sodium's registration, Green Valley faces significant operational challenges, including a reported plan to cut nearly 80% of its workforce [12].