【文/王力 编辑/周远方】 "上午陪老爸去医院，被通知神药断供了，问题是这药效果真的很好，老爸回复的确实很好"，浙江的徐先生在社交平台发文表示，此前徐先生父亲一直服用 的阿尔兹海默病药物被通知断药，现在在寻求别的药物替代。 类似的求助帖正在全国多地阿尔茨海默病患者家庭中上演。2025年6月，中国原创抗阿尔茨海默病药物绿谷医药旗下的甘露特钠胶囊（商品名"九期一"）突 然停产，让依赖该药的患者陷入断药困境。 这场断药危机在5月初悄然爆发，并在6月达到顶峰。在绝望的患者家属四处奔走之际，一批冠以"同仁堂甘露特钠胶囊"、"甘露药食同源浓缩丸"、"971甘露 特特钠胶囊原研特钠甘露合理配"之名的假冒药品惊现电商平台，正吞噬着阿尔茨海默病患者的最后希望。 随着正品消失，药品黑市开始猖獗。在电商平台上，原本每月花费约296元（医保后价格）的药品，半个月的价格就被炒到534.5元，部分第三方药房甚至挂 出5000元一盒的天价。 患者刚下单付款，商家就以"无货"为由退款，随后以更高价格重新上架。在淘宝和京东等平台搜索"甘露特钠"，仅有少数店铺有售，价格甚至一度高达近 3000元却也显示缺货。 李鬼横行，同仁堂招牌下的假药陷阱 ...

每经记者｜许立波 每经编辑｜张益铭 在中国创新药的投资热情空前高涨之际，一款曾因"国人自主研发的抗阿尔茨海默病新药"而名噪一时的明星产品甘露特钠胶囊（"九期一"），正陷入停产风 波。 6月12日，"九期一"研发生产企业绿谷（上海）医药科技有限公司（以下简称"绿谷制药"）副总经理王慧向《每日经济新闻》记者独家回应，公司已于2025 年5月30日发布内部通知，"九期一"相关岗位已停工停产。停产原因主要是"九期一"的药品注册证已于2024年11月2日到期，且未能如期完成续期审批。目前 监管机构尚未给出明确答复，但企业一直在积极沟通。 此外，绿谷制药方面也书面回应记者，本次临时性调整方案仅限于"九期一"产品线相关岗位。停工员工实发工资将按上海市最低工资标准发放，社保公积金 正常缴纳。待再审批通过及恢复生产经营后，公司将第一时间恢复原薪酬标准。 绿谷制药公司总部 图片来源：每经记者 许立波 摄 监管机构尚未给出明确答复，企业一直在积极沟通 国家药品监督管理局药品审评中心（CDE）官网显示，"九期一"早在2024年10月25日就提交了注册证续期申请，但截至目前仍处于"排队待审评"状态。为 何"九期一"迟迟未能完成续期？是 ...

Core Viewpoint - The news highlights the supply issues surrounding GV-971 (甘露特钠胶囊), a drug for Alzheimer's disease, which has led to a significant price increase and potential production halt due to regulatory challenges and cash flow problems faced by the manufacturer,绿谷制药 [1][3][5]. Group 1: Supply and Demand - GV-971 has been experiencing a supply shortage since six months ago, with recent reports indicating complete stockouts, causing prices to surge from 296 yuan to between 830 yuan and 1,033 yuan per box [1]. - Over 9,300 patients have requested the drug, and more than 1,200 doctors have urged the company to ensure continuous supply [1]. - The company is in communication with relevant authorities to expedite the review process for the drug's certification renewal [1][2]. Group 2: Regulatory and Clinical Background - GV-971 was conditionally approved in November 2019, becoming the first drug targeting the "gut-brain axis" mechanism for Alzheimer's treatment [3]. - The drug's approval was contingent upon the submission of long-term carcinogenicity data, which was completed and submitted in December 2019, showing no carcinogenic risk [3]. - The drug has been under review since October 2024, but its approval status remains pending, possibly due to ongoing debates regarding its efficacy [4]. Group 3: Financial Performance and Market Impact - Since its launch, GV-971 has reportedly benefited over 500,000 patients, with sales reaching 2.13 million boxes in 2024 alone [5]. - The drug's sales have grown at a compound annual growth rate of 343.2% since its approval, with hospital sales reaching 170 million yuan and retail sales at 156 million yuan in 2022 [5]. - The company has faced severe cash flow issues, leading to temporary layoffs and reduced salaries for employees [2]. Group 4: Alternative Treatments and Market Landscape - Despite the supply issues with GV-971, other established treatments for Alzheimer's disease, such as cholinesterase inhibitors and NMDA receptor antagonists, remain available [6]. - Newer drugs like Eli Lilly's donanemab and Eisai's lecanemab have also entered the market, providing additional options for patients [7]. - The Alzheimer's drug development landscape is characterized by high investment and risk, with over $100 billion invested globally, yet only one drug successfully launched from over 200 clinical trials [8][9].

每经记者｜许立波 每经编辑｜张益铭 在中国创新药的投资热情空前高涨之际，一款曾因"国人自主研发的抗阿尔茨海默病新药"而名噪一时的 明星产品"九期一"，正陷入停产风波。 在位于青浦的"绿谷生命园"，记者发现虽有少数员工仍在岗，但现场同样未见明显生产活动。在持续数 小时的观察中，记者仅见到一辆医药冷链运输车进出厂区。在与现场一位员工攀谈时，他告诉记 者："该厂区还在做药，并未停工。" 绿谷制药位于上海浦东的生产基地项目投资合计12.27亿元，本应于2024年底前完成验收并投入运行。 但现场一位员工却告诉记者，该基地自大楼落成以来就没有真正投入使用。"厂子建好后就空着了，没 见有生产过，也没装修。" 对此，王慧向记者确认称，青浦基地确实仍在运转，但主要承担的是丹参多酚酸盐原料及制剂的生 产，"九期一"的相关产线已经停产。浦东生产基地自建成后未投入使用"确实是因为'九期一'的注册证延 期、叠加公司目前的资金困难，导致项目处于停滞状态"。 她还表示，目前监管机构尚未给出明确答复，但企业一直在积极沟通，今年3月、4月去北京参加了专家 评审会并答辩。 在谈到公司将如何纾困解难时，王慧表示："我们还是希望通过完成手头的相关工 ...

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 Viewpoint - The news highlights the suspension of production for the Alzheimer's drug "Jiuqi Yi" (Glycyrrhizin Sodium Capsules) by Green Valley Pharmaceutical due to the expiration of its licensing approval, raising concerns among patients about when the drug will resume production [1] Group 1: Drug Status - The drug "Jiuqi Yi" is required to supplement Phase III clinical data before it can regain its licensing approval [1] - The primary inventor of the drug, researcher Geng Meiyu, confirmed that the Phase III clinical trials will continue [1] - Green Valley Pharmaceutical has not provided a clear response regarding the further development of the clinical trials for the drug [1] Group 2: Historical Context - "Jiuqi Yi" was conditionally approved for market release in November 2019, recognized as China's first original drug for treating Alzheimer's disease [1] - The approval process for the new drug took less than a year from application acceptance to approval, marking it as the first new drug approved for Alzheimer's treatment globally in nearly 20 years [1]

"前期的三期临床数据不够充分，仅做了一组临床，一般国际上的惯例是要做两组平行临床试验，由两 个不同的医院牵头完成多中心临床试验，看下两组得到的结果是否一致。" 近日，绿谷医药科技（下称"绿谷"）生产的抗阿尔茨海默病国产药甘露特钠胶囊（"九期一"）因许可批 件到期停产的消息引发患者关注。 有患者迫切想知道，"九期一"何时能获得许可批件恢复生产。知情人士对第一财经记者表示："这款药 物被要求补充三期临床数据。" 不过知情人士告诉第一财经记者，在新冠疫情期间，绿谷制药停掉了在美国开展的全球临床试验，原本 的国际多中心临床，后来变成只在国内开展的两三千人规模的临床。 据他透露，目前的临床试验显示了该药物具有一定的疗效，有效性达到约58%，但临床试验的设计是否 严谨仍有争议。"阿尔茨海默病的评估通常是通过量表评分来衡量的，这本身也带有一定的主观性。" 截至发稿，绿谷制药未就该药物临床试验如何进一步开展给出第一财经记者明确的回应。 2019年11月，有"中国原创治疗阿尔茨海默病新药"之称的"九期一"附条件获批上市，新药上市申请从受 理到获批历时不到一年。这款药物也是当时近20年以来全球首个被批准用于治疗阿尔茨海默病的新药 ...

Core Viewpoint - The prescription drug GV-971 (brand name "Jiuyiqi") for Alzheimer's disease has been discontinued, leading to a significant price increase and supply shortages, raising concerns about the company's future and the drug's efficacy [1][3][4]. Group 1: Company Situation - Green Valley Pharmaceutical Technology is facing severe cash flow issues, having notified all employees of a three-month leave starting in June, with salaries reduced to 2,600 yuan per month [3][4]. - The company has indicated that the drug's production halt is due to the expiration of its drug registration certificate, with new approvals pending [5][6]. - There have been over 9,300 patient requests for the drug, and more than 1,200 doctors have urged the company to ensure the supply of GV-971 [6][7]. Group 2: Drug Efficacy and Controversy - GV-971 has been subject to academic controversy, with former president of Capital Medical University, Rao Yi, questioning the authenticity of the research and the drug's effectiveness, alleging research misconduct [4][8]. - The drug was conditionally approved by the National Medical Products Administration in November 2019, and it was included in the medical insurance list in 2021 at a price of 296 yuan per box [4][7]. - Despite the controversies, the company claims that the drug has shown improvements in cognitive function in patients during clinical studies, with results expected to be presented at international academic conferences [7][10]. Group 3: Market Dynamics - The price of GV-971 has surged to between 830 yuan and 1,033 yuan per box due to supply shortages, compared to its original price of 296 yuan [1][4]. - The drug has sold 2.13 million boxes in 2024 alone, indicating a significant market presence despite the ongoing controversies [4][11]. - The approval process for new drugs in the Alzheimer's treatment space is generally slow, with industry insiders suggesting that the ongoing efficacy debates may be contributing to the delays in GV-971's new registration [6][8].

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]

以下文章来源于21新健康 ，作者唐唯珂 21新健康 . 21世纪传媒 · 公众号矩阵成员。 作 者丨唐唯珂 用于治疗阿尔茨海默病的甘露特钠胶囊停产了 。6月8日，绿谷医药科技（以下简称"绿谷"） 被爆 出将关闭甘露特钠胶囊相关的办公区、生产区 。据 21世纪经济报道记者多渠道调查发 现，该消息属实 。 甘 露 特 钠 胶 囊 （ 商 品 名 " 九 期 一 " ） 是 绿 谷 研 发 并 生 产 的 用 于 轻 度 至 中 度 阿 尔 茨 海 默 病 （AD），改善患者认知功能的药物。近期，多地患者反馈医院开不出甘露特钠胶囊处方，线 下零售药店和线上购物平台也出现药品供应紧张，价格持续上涨的情况，相关的"断货"消息 在社交平台持续发酵。 针对上述情况，早在5月19日，绿谷方面曾在官网发布公告回应，"我们陆续收到各地患者关 于甘露特钠胶囊'购药难'的情况，以及个别购药渠道急速涨价。我们深知用药中断会对病情产 生重大影响，对此我们深表遗憾。我们正与有关部门密切沟通，竭尽全力处理相关供货问 题，以尽快满足患者的迫切治疗需求。"但 该公告于5月23日被删除。绿谷方面更是屡次被媒 体报道近期面临严重经营压力，现金流极度 ...