绿谷971再注册申请未获批准：争议与困境仍存

Core Viewpoint - The re-registration application for GV-971 (甘露特钠胶囊) by Green Valley Pharmaceutical has been denied, marking a significant challenge for this Alzheimer's disease drug that has been controversial since its conditional approval in 2019 [1][4]. Company Summary - GV-971, developed by Green Valley, is aimed at improving cognitive function in patients with mild to moderate Alzheimer's disease. It was conditionally approved in November 2019, filling a 17-year gap in new Alzheimer's drug approvals [1][2]. - The drug's approval was based on its unique mechanism targeting the gut-brain axis, using low molecular weight acidic oligosaccharides derived from marine brown algae, differing from the mainstream β-amyloid hypothesis [2]. - Following the denial of the re-registration application, Green Valley's production has been halted, and the drug has faced supply shortages and price increases across various platforms [1][4]. Industry Summary - The denial of GV-971's re-registration reflects the complexities involved in the development and approval of Alzheimer's drugs, highlighting potential issues with clinical trial data and efficacy [4][5]. - The drug's conditional approval required the completion of clinical trials and submission of formal reports, which have not been satisfactorily met, leading to the current situation [2][3]. - There are currently no other drugs with a similar mechanism approved, although alternative symptomatic treatments are available, such as donepezil, which some patients have switched to following GV-971's supply issues [5].