红星资本局12月23日消息 12月22日晚，复星医药（600196.SH；02196.HK）发布公告，回复上交所下发 的监管工作函。 关于对绿谷（上海）医药科技有限公司（以下简称"绿谷医药"）的投资事项，复星医药回应了具体交易 方式、阿尔茨海默病（AD）药物甘露特钠胶囊（商品名"九期一"）临床进展及后续整合等问题。 炒股就看金麒麟分析师研报，权威，专业，及时，全面，助您挖掘潜力主题机会！ 截图自绿谷医药官网 12月15日，复星医药宣布控股子公司复星医药产业拟出资14.12亿元控股投资绿谷医药，意在将绿谷医 药核心药品甘露特钠胶囊纳入公司创新药品管线，完善阿尔茨海默病领域布局。 这笔高达14亿元的交易引发投资者热议，甚至一度"带崩"公司股价。12月16日，复星医药A股下跌 4.22%，港股下跌5.81%。 资料显示，甘露特钠胶囊曾于2019年11月获国家药监局有条件批准上市，用于轻度至中度阿尔茨海默病 治疗，成为继2002年美金刚（治疗中重度至重度阿尔茨海默型痴呆）获批上市后，全球首个获批上市的 AD治疗药物。 但是，甘露特钠胶囊自获批以来疗效问题饱受市场争议。原首都医科大学校长饶毅曾多次发文质疑相关 研究的真 ...

Core Viewpoint - GV-971 (also known as "Jiuyiqi"), an Alzheimer's disease drug, is facing challenges in its clinical validation and regulatory approval process, with significant market reactions following the announcement of its acquisition by Fosun Pharma [1][3]. Group 1: Clinical Research and Approval Status - GV-971's confirmatory clinical research plan has been approved by the drug review center, with 580 patients enrolled so far, and the acquisition funds will be used to advance clinical trials [1][3]. - The drug received conditional approval in November 2019 but failed to complete the necessary post-marketing confirmatory clinical studies, leading to its inability to achieve full approval by the expiration of its registration certificate in November 2024 [3][10]. - The drug's post-marketing confirmatory clinical trial, which began in October 2022, has faced delays, with only 580 out of the targeted 1,312 patients enrolled as of December 2023, indicating significant progress issues [10][11]. Group 2: Market Reaction and Investor Sentiment - Following the announcement of the acquisition plan on December 15, Fosun Pharma's A-shares fell over 4% and H-shares dropped more than 5% by December 16, reflecting investor skepticism regarding the drug's future [1][3]. - The trading volume and value on December 16 were the highest in a week, indicating heightened market activity and concern [1]. Group 3: Research Design and Methodology - The real-world study required for long-term safety and efficacy has been submitted, but the duration of the data collected is only 48 weeks, half of the originally designed 96 weeks, which raises concerns about its adequacy [7][9]. - The confirmatory clinical trial design has been updated to include 1,950 patients and extend the double-blind treatment period from 36 weeks to 48 weeks, aligning it more closely with international standards for Alzheimer's drug trials [11][12].

【复星医药：甘露特钠胶囊累计销售19.2亿元 2029年上半年递交总结报告】12月23日，针对上交所监管 工作函，复星医药（600196.SH）进行了回复。公告显示，自2019年获批上市以来，治疗阿尔茨海默病 （AD）的甘露特钠胶囊累计销售额为19.2亿元，累计销售数量为677.11万盒。 上市后确证性临床试验方案计划入组患者1950例。截至2025年12月15日，已累计入组580例、尚需入组 1370例。基于该项目临床方案预估，2027年年底全部受试者可完成入组，2029年年初可完成相关研究并 读出数据，2029年上半年向国家药监局递交临床试验总结报告等资料。中经记者 晏国文 卢志坤 北京报 道 12月15日，复星医药方面披露，拟出资14.12亿元投资控股绿谷医药。甘露特钠胶囊是绿谷医药的核心 产品。不过，自2024年11月起，甘露特钠胶囊未开展商业化生产。因此甘露特钠胶囊在2025年的销售受 到较大影响。 复星医药公告显示，2024年，甘露特钠胶囊原药品注册批件5年有效期到期前，标的公司（绿谷医药） 向监管机构提交关于批准文号有效期事项的补充申请，但因前述上市后确证性临床研究仍在进行中，尚 未完成，根据药 ...

（文章来源：中国经营报） （甘露特钠胶囊历年销售数据。 公司公告/图） 12月23日，针对上交所监管工作函，复星医药（600196.SH）进行了回复。公告显示，自2019年获批上市以来，治疗阿尔茨海默病（AD）的甘露特钠胶囊累 计销售额为19.2亿元，累计销售数量为677.11万盒。 12月15日，复星医药方面披露，拟出资14.12亿元投资控股绿谷医药。甘露特钠胶囊是绿谷医药的核心产品。不过，自2024年11月起，甘露特钠胶囊未开展 商业化生产。因此甘露特钠胶囊在2025年的销售受到较大影响。 复星医药公告显示，2024年，甘露特钠胶囊原药品注册批件5年有效期到期前，标的公司（绿谷医药）向监管机构提交关于批准文号有效期事项的补充申 请，但因前述上市后确证性临床研究仍在进行中，尚未完成，根据药品注册的相关法规，国家药监局未予批准，并要求继续完成正在进行的上市后确证性临 床研究。 上市后确证性临床试验方案计划入组患者1950例。截至2025年12月15日，已累计入组580例、尚需入组1370例。基于该项目临床方案预估，2027年年底全部 受试者可完成入组，2029年年初可完成相关研究并读出数据，2029年上半年向 ...

2025.12.23 本文字数：1414，阅读时长大约3分钟 作者 |第一财经 林志吟 本次收购绿谷医药，复星医药采用"受让存量股权+认购新增注册资本"组合方式，交易款项分期支付， 首期6.35亿元于交割日支付，剩余6.35亿元将在首期款支付完成之日起三年内根据标的公司的研发进展 情况支付。 复星医药表示，该设计既保障了标的公司临床推进的资金需求，又为公司提供了动态风险管控空间。此 外，标的公司创始人控制的主体将质押本次收购后所持有的标的公司10%的股权为潜在风险事项可能造 成的损失提供担保，进一步强化了交易的安全性。 甘露特钠胶囊重新开展商业化生产和销售前，还需（其中主要包括）补充完成目前尚在开展的上市后确 证性临床试验并获得国家药品审评部门批准。 复星医药目前表示，未发现开展该确证性临床试验存在尚未解决的核心技术问题、未发现后续推进该确 证性临床试验存在实质障碍。 就市场关切的后续临床进展，复星医药表示，根据2025年5月国家药监局药审中心发布的《阿尔茨海默 病药物临床试验技术指导原则（试行）》，为符合国内最新研究规范、并参考国际上对该类药物确证性 临床研究的要求，经2025年10月与国家药监局药审中心沟 ...

Core Viewpoint - The acquisition of Green Valley Pharmaceutical by Fosun Pharma for 1.412 billion yuan has led to a significant drop in the company's stock price and triggered regulatory scrutiny from the Shanghai Stock Exchange [3][4]. Group 1: Acquisition Details - Fosun Pharma aims to acquire Green Valley Pharmaceutical primarily to obtain the Alzheimer's drug, Ganluo Sodium Capsule, which has faced efficacy controversies since its conditional approval in November 2019 [3][4]. - The acquisition involves a combination of "acquiring existing equity + subscribing to new registered capital," with a phased payment structure: an initial payment of 635 million yuan at closing, followed by another 635 million yuan based on the target company's R&D progress over three years [5]. - The founder-controlled entity of Green Valley will pledge 10% of the company's shares to secure potential losses from the acquisition, enhancing transaction safety [5]. Group 2: Clinical Trial Progress - Fosun Pharma has communicated that the clinical trial for Ganluo Sodium Capsule is being revised to meet the latest regulatory standards, extending the double-blind treatment period from 36 weeks to 48 weeks and increasing the sample size from 1,312 to 1,950 participants [6]. - As of December 15, 2025, 580 participants have been enrolled in the clinical study, with projections indicating that all participants could be enrolled by the end of 2027, and data could be available by early 2029 [7].

【#复星医药14.12亿元投资带崩股价##复星医药回应收购AD药物争议# 】或许令复星医药 （600196.SH；02196.HK）没有想到的是，公司上周抛出的拟14.12亿元收购绿谷医药行动，居然会"带 崩"公司股价，且收到了上海证券交易所的《监管工作函》。 12月22日晚间，针对投资绿谷医药具体交易方式、阿尔茨海默病（AD）药物甘露特钠胶囊临床进展及 后续整合等问题，复星医药方面进行了回应。 甘露特钠胶囊是绿谷医药的主要品种，该药曾于2019年11月获国家药监局有条件批准上市，用于轻度至 中度阿尔茨海默病治疗，彼时成为继2002年美金刚（治疗中重度至重度阿尔茨海默型痴呆）获批上市17 年后，全球首个获批上市的AD治疗药物。 ...

甘露特钠胶囊确证性临床研究获药审中心认可 或许令复星医药（600196.SH；02196.HK）没有想到的是，公司上周抛出的拟14.12亿元收购绿谷医药行 动，居然会"带崩"公司股价，且收到了上海证券交易所的《监管工作函》。 12月22日晚间，针对投资绿谷医药具体交易方式、阿尔茨海默病（AD）药物甘露特钠胶囊临床进展及 后续整合等问题，复星医药方面进行了回应。 甘露特钠胶囊是绿谷医药的主要品种，该药曾于2019年11月获国家药监局有条件批准上市，用于轻度至 中度阿尔茨海默病治疗，彼时成为继2002年美金刚（治疗中重度至重度阿尔茨海默型痴呆）获批上市17 年后，全球首个获批上市的AD治疗药物。 但是，甘露特钠胶囊自获批以来疗效问题饱受市场争议。在2024年甘露特钠胶囊药品注册批件5年有效 期到期前，绿谷医药向监管机构提交补充申请以延长批件有效期，但因未能按照监管机构要求完成上市 后确证性临床研究，国家药监局未予批准。因注册批件到期，2024年11月起，该药品未开展商业化生 产。 本次收购绿谷医药，复星医药采用"受让存量股权+认购新增注册资本"组合方式，交易款项分期支付， 首期6.35亿元于交割日支付，剩余6.3 ...

Core Viewpoint - Fosun Pharma is acquiring a controlling stake in Green Valley Pharmaceutical for approximately 14.12 billion RMB, despite the core product, Manzamine Sodium Capsule, being off the market due to regulatory issues. The acquisition has raised concerns in the capital market regarding the timeline for the product's return to commercialization [2][3][4]. Group 1: Acquisition Details - The acquisition will be executed through a combination of stock transfer and subscription to new registered capital, resulting in Fosun Pharma holding 51% of Green Valley Pharmaceutical [4]. - The payment for the acquisition will be made in installments, with an initial payment of 635 million RMB at the time of closing, and the remaining amount contingent on the progress of Green Valley's research and development [4]. - Green Valley's founder will pledge 10% of the company's shares post-acquisition to mitigate potential risks [4]. Group 2: Clinical Trial and Product Timeline - The revised post-marketing confirmatory clinical trial for Manzamine Sodium Capsule has been approved, with full enrollment expected by the end of 2027 and data readout in early 2029 [2][7]. - The product has been off the market since November 2024 due to the expiration of its registration certificate and will require successful completion of the clinical trial and regulatory approval before resuming sales [7][8]. Group 3: Financial and Compliance Status - Green Valley Pharmaceutical has faced regulatory scrutiny, including a 400,000 RMB fine for improper promotional practices, but this has not significantly impacted its operations [9][10]. - An audit revealed no hidden large debts or misuse of funds within Green Valley, indicating a stable financial position prior to the acquisition [10][12]. - As of September 30, 2025, Green Valley's assets and liabilities were 806 million RMB and 795 million RMB, respectively, which have a limited impact on Fosun Pharma's overall financial structure [12]. Group 4: Market Competition and Future Risks - The market for Alzheimer's treatments is competitive, with six other drugs already approved, which may affect the sales performance of Manzamine Sodium Capsule upon its return to the market [8]. - The timeline for the product's re-commercialization has been extended to around 2029, raising concerns about market dynamics and reimbursement conditions at that time [8].

Core Viewpoint - Fosun Pharma is acquiring a controlling stake in Green Valley Pharmaceutical for approximately RMB 1.412 billion, aiming to integrate its core drug GV-971 into its innovative drug pipeline for Alzheimer's disease treatment [1][2]. Group 1: Acquisition Details - The acquisition involves a combination of "transferring existing equity + subscribing to new registered capital," with Fosun Pharma set to hold 51% of Green Valley's shares [2]. - The total transaction amount of RMB 1.269 billion will be paid in installments, with the first payment of RMB 635 million made on the closing date, and the remaining RMB 634 million to be paid within three years based on the company's R&D progress [2][3]. - The founder-controlled entity of Green Valley will pledge 10% of the company's shares post-acquisition to provide guarantees against potential risks [2]. Group 2: Clinical Trial and Product Development - The acquisition will provide necessary funding for the clinical trials of GV-971 and support its commercialization, including clinical operations, registration, and marketing [3]. - The clinical trial design for GV-971 has been revised to extend the double-blind medication period from 36 weeks to 48 weeks and increase the sample size from 1,312 to 1,950 participants, in accordance with the latest guidelines from the National Medical Products Administration [3][4]. - As of December 15, 2025, 580 participants have been enrolled in the clinical study, with completion of enrollment expected by the end of 2027 and data readout anticipated in early 2029 [4]. Group 3: Strategic Positioning - Fosun Pharma has been focusing on the central nervous system degenerative disease sector, enhancing its product portfolio with a collaborative innovation model that includes both drugs and devices [4][5]. - This acquisition represents a strategic move to address unmet clinical needs in the treatment of Alzheimer's disease, further enriching the company's innovative product pipeline and market positioning [5].