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].

Core Insights - The Chinese original drug "Jiuyiqi®" (Guanluo Sodium) has been discontinued after five years, marking a significant event in the Alzheimer's disease (AD) drug market [1][2] - Initially approved in November 2019, Jiuyiqi® was celebrated as the first targeted AD drug, but faced ongoing scrutiny regarding its safety and efficacy [1][2] Group 1: Drug Approval and Market Performance - Jiuyiqi® received "conditional approval" from the National Medical Products Administration, which required further submission of carcinogenicity test reports and long-term efficacy data [1] - The drug experienced a surge in demand upon its market entry and was included in the national medical insurance directory in 2021, expanding its market presence [2] - However, following the termination of international trials and internal team instability, sales declined sharply, leading to reports of stock shortages in pharmacies [2] Group 2: Controversies and Challenges - The drug's unique "gut-brain axis" mechanism faced strong criticism from the academic community, raising questions about its scientific validity [1] - Controversies arose from the clinical trial results, where the treatment group showed effects within four weeks, while the placebo group unexpectedly worsened, leading to debates over trial design [1] - The international Phase III trial, originally set to complete in 2025, was prematurely terminated in 2022, attributed to patient dropouts due to the pandemic and financing difficulties, which did not alleviate concerns over data reliability [1][2] Group 3: Regulatory and Industry Implications - The discontinuation of Jiuyiqi® serves as a warning for the Chinese innovative drug sector, highlighting the risks associated with "conditional approval" [2] - The situation raises questions about the regulatory environment and whether the approval process is becoming more stringent, as the company did not publicly address the reasons for the discontinuation [2] - The industry is urged to recognize that significant original mechanisms must withstand rigorous scrutiny from international peers, and academic criticism should be viewed as an opportunity to enhance research quality [2]