近日，多地患者家属称，首款国产阿尔茨海默病新药甘露特钠胶囊(商品名：九期一)开始断货。有消息 称该药品生产方上海绿谷医药科技(下称"绿谷医药")已发布内部通知，宣布甘露特钠胶囊产品线的相关 岗位停工停产。6月12日，绿谷医药向南都记者透露，"甘露特钠胶囊目前的审评审批已进入最终阶段， 我们正与有关部门密切沟通，相信患者治疗需求将很快得到满足。" 国产阿尔茨海默病新药线上单价超千元 南都记者在多个电商平台搜索发现，可用于轻度至中度阿尔茨海默病，改善患者认知功能的甘露特钠胶 囊，商品规格为150mg，42粒/每盒，线上售价均在千元以上。页面医嘱显示，该药品每日需服用2次， 每次3粒。部分店铺显示，该药品已售出超100盒。 甘露特钠胶囊网售单价均在千元以上。 据公开信息，2019年11月，甘露特钠胶囊"九期一"获得国家药监局(NMPA)有条件批准上市，并于2021 年年底正式纳入医保目录，价格从895元/盒降至296元/盒。 南都记者留意到，近期有传闻称，甘露特钠胶囊陷入断货，是由于该产品注册证到期后，审批未能通 过，因此导致该产品线的相关岗位停工停产。 针对上述传闻，6月12日，绿谷医药在接受南都记者采访时透露， ...

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]

2025年5月16日，绿谷（上海）医药科技有限公司（以下简称"绿谷医药科技"）正式宣布，基于多维度 的证据体系评价与分级，其调节脑肠轴的创新药物甘露特钠（商品名：九期一 ）获《阿尔茨海默病多 元康复干预中国专家共识（2025）》（以下简称《共识》）强推荐，并被评定为高证据质量级别。 《共识》由中国阿尔茨海默病防治协会（中国）及其认知康复专业分会牵头，康复医学、神经病学、老 年医学、精神医学、全科医学、预防医学、中医学及护理学等多学科专家共同参与撰写，并已于2025年 5月15日发表在《阿尔茨海默病及相关病杂志》上。其采用"德尔菲法结合证据分级与推荐强度评价系 统"进行证据分级，最终形成预防、治疗、康复和照护 4 个层面的 23 项共识意见。 甘露特钠作为西药治疗方面调节脑肠轴的药物，在《阿尔茨海默病多元康复干预中国专家共识 （2025）》中获得高证据质量级别、强推荐。 该系统根据研究的类型和质量，给予证据不同的分级与推荐强度评价。证据质量被分为4个等级（高、 中、低、非常低）。专家从研究设计、样本量、统计方法等多维度为文献评分，最终形成证据的质量等 级和推荐意见的强度（强推荐、弱推荐），并依照国际实践指南报告 ...