绿谷医药回应“国产阿尔茨海默病新药断货”！药品注册证到期

Core Viewpoint - The first domestic Alzheimer's disease drug, Ganluotena Capsules (brand name: Jiuqi Yi), is facing a supply shortage due to production halts related to its registration certificate expiration, but the company, Shanghai Green Valley Pharmaceutical Technology, is in the final stages of approval and is optimistic about resuming supply soon [1][2]. Group 1: Product and Market Information - Ganluotena Capsules are priced over 1,000 yuan per box online, with a specification of 150mg and 42 capsules per box, requiring patients to take 6 capsules daily [1]. - The drug was conditionally approved by the National Medical Products Administration (NMPA) in November 2019 and was included in the medical insurance directory at the end of 2021, with the price reduced from 895 yuan to 296 yuan per box [1]. - Since its launch, over 500,000 patients have used Ganluotena, with sales exceeding 2.1 million boxes in 2024 alone [5]. Group 2: Regulatory and Production Status - The production halt is temporary and limited to the Ganluotena product line due to the need for a new registration certificate, with employees receiving minimum wage during this period [2]. - The company submitted supplementary applications for Ganluotena in May and October 2024, which will undergo comprehensive evaluation by the drug review center [3]. Group 3: Scientific and Clinical Background - Ganluotena is the world's first drug targeting the gut-brain axis for Alzheimer's disease, aiming to reshape gut microbiota, inhibit neuroinflammation, and improve cognitive function [4]. - The drug has faced controversy regarding its mechanism and the authenticity of research papers by its main inventor, but legal challenges against these criticisms have been dismissed [4].