转自：北京日报客户端 新版医保目录已进入实质性落地阶段。1月8日，北京商报记者注意到，包括替妥尤单抗N01注射液、夫 那奇珠单抗注射液在内的多款新增创新药，已在多地医院纷纷开出医保首方。这标志着患者使用这些高 价创新药的实际门槛正在快速降低，新版目录的惠民效应开始显现。 本次医保目录调整不仅新增了114种药品，更首次同步推出《商业健康保险创新药品目录（2025 年）》，通过"基本医保+商保"的双重保障，为肿瘤、罕见病等领域19种高值药品开辟了可及的支付通 路，医保支付体系向多层次保障的实质性转型迈出关键一步，创新药企也迎来了加速商业化放量的重要 节点。 从上市到开出医保首方不足一年 创新药迅速落地医保，是新版医保目录对具有高临床价值"真创新"支持力度加大的直接体现。本次调整 中，新版医保目录与商保创新药目录共纳入独家品种124个。 其中，备受关注的替妥尤单抗N01注射液是国内首款用于治疗甲状腺眼病的靶向药物，从2025年3月上 市，到开出医保首方，用时不到一年，填补了我国该领域近70年的治疗空白。 夫那奇珠单抗注射液则是用于治疗银屑病的生物制剂1类创新药，由恒瑞医药自主研发。恒瑞医药在本 次医保目录调整中被视 ...

新版医保目录已进入实质性落地阶段。1月8日，北京商报记者注意到，包括替妥尤单抗N01注射液、夫 那奇珠单抗注射液在内的多款新增创新药，已在多地医院纷纷开出医保首方。这标志着患者使用这些高 价创新药的实际门槛正在快速降低，新版目录的惠民效应开始显现。 倒逼药企研发策略转向真创新 本次医保目录调整不仅新增了114种药品，更首次同步推出《商业健康保险创新药品目录（2025 年）》，通过"基本医保+商保"的双重保障，为肿瘤、罕见病等领域19种高值药品开辟了可及的支付通 路，医保支付体系向多层次保障的实质性转型迈出关键一步，创新药企也迎来了加速商业化放量的重要 节点。 不到一年开出医保首方 创新药迅速落地医保，是新版医保目录对具有高临床价值"真创新"支持力度加大的直接体现。本次调整 中，新版医保目录与商保创新药目录共纳入独家品种124个。 其中，备受关注的替妥尤单抗N01注射液是国内首款用于治疗甲状腺眼病的靶向药物，从2025年3月上 市，到开出医保首方，用时不到一年，填补了我国该领域近70年的治疗空白。 夫那奇珠单抗注射液则是用于治疗银屑病的生物制剂1类创新药，由恒瑞医药自主研发。恒瑞医药在本 次医保目录调整中被视为 ...

新版医保目录已进入实质性落地阶段。1月8日，北京商报记者注意到，包括替妥尤单抗N01注射液、夫那奇珠单抗注射液在内的多款新增创新药，已在多地 医院纷纷开出医保首方。这标志着患者使用这些高价创新药的实际门槛正在快速降低，新版目录的惠民效应开始显现。 本次医保目录调整不仅新增了114种药品，更首次同步推出《商业健康保险创新药品目录（2025年）》，通过"基本医保+商保"的双重保障，为肿瘤、罕见病 等领域19种高值药品开辟了可及的支付通路，医保支付体系向多层次保障的实质性转型迈出关键一步，创新药企也迎来了加速商业化放量的重要节点。 从上市到开出医保首方不足一年 创新药迅速落地医保，是新版医保目录对具有高临床价值"真创新"支持力度加大的直接体现。本次调整中，新版医保目录与商保创新药目录共纳入独家品种 124个。 其中，备受关注的替妥尤单抗N01注射液是国内首款用于治疗甲状腺眼病的靶向药物，从2025年3月上市，到开出医保首方，用时不到一年，填补了我国该 领域近70年的治疗空白。 | | | 基本医保目录"上新"药品定点医药机构销售情况(2026年1月1日至1月6日) | | | | --- | --- | --- | ...

12月22日晚间，复星医药（SH600196，股价27.09元，市值723.4亿元）发布关于回复上海证券交易所就 绿谷（上海）医药科技有限公司（以下简称绿谷医药）投资事项监管工作函（以下简称回复函）的公 告，披露了关于其具体交易方式、后续整合以及治疗阿尔茨海默病的药物——甘露特钠胶囊（商品 名"九期一"）后续临床试验的进展等内容。 《每日经济新闻》记者了解到，对于这笔交易，市场最为关注的问题，还是复星医药收购绿谷医药若完 成，"何时才能将'九期一'重新推向市场"。 根据复星医药公告，甘露特钠胶囊修订后的上市后确证性临床试验，目前已获国家药监局药审中心认 可。基于该项目临床方案预估，2027年底全部受试者可完成入组，2029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。 此外，复星医药公告还披露，此前，绿谷医药曾以不合理会议名义支付讲课费等违规宣传销售甘露特钠 胶囊，并因此被浦东新区市场监督管理局作出行政处罚并处40万元罚款。 对此，复星医药方面称，前述处罚未对绿谷医药经营造成重大不利影响。同时，基于审计报告及尽调， 未发现绿谷医药存在隐性大额债务和资金被占用的情况。 ...

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].

"当化疗成为唯一选项时，我们需要的不仅是技术，更是支付的勇气。"一位鼻咽癌患者曾在其自述中如 是写道。这句话背后，是无数癌症患者面对天价创新药时的无奈——即便新药能带来生存希望，但高昂 的费用却让希望沦为奢望。这种困境在罕见病领域尤为突出，患者往往需自费承担数十万元甚至上百万 元的年治疗费用。 这种支付与需求的错配正在找到新的解决路径。12月13日，全国医疗保障工作会议在北京召开，明确提 出2026年要支持商业健康保险发展，健全多层次医疗保障体系，并特别强调要"积极落地商保创新药品 目录"，在个人充分授权和确保数据安全基础上，为有需要的商业健康保险产品提供"医保+商保"一站式 清分结算服务。 12月7日，2025年国家基本医保药品目录及首版商保创新药目录在广州正式发布，将于2026年1月1日起 正式实施。此次国家医保局首次在基本医保目录之外增设商保创新药目录，共纳入19种药品，涵盖 CAR-T等肿瘤治疗药品、神经母细胞瘤等罕见病治疗药品，以及社会关注度较高的阿尔茨海默病治疗药 品。 国家医保局表示，商保创新药目录重点纳入创新程度高、临床价值大、患者获益显著且超出基本医保保 障范围的创新药，推荐商业健康保险、医 ...

来源：财经五月花 作者：丁艳 杨芮 这种支付与需求的错配正在找到新的解决路径。12月13日，全国医疗保障工作会议在北京召开，明确提 出2026年要支持商业健康保险发展，健全多层次医疗保障体系，并特别强调要"积极落地商保创新药品 目录"，在个人充分授权和确保数据安全基础上，为有需要的商业健康保险产品提供"医保+商保"一站式 清分结算服务。 12月7日，2025年国家基本医保药品目录及首版商保创新药目录在广州正式发布，将于2026年1月1日起 正式实施。此次国家医保局首次在基本医保目录之外增设商保创新药目录，共纳入19种药品，涵盖 CAR-T等肿瘤治疗药品、神经母细胞瘤等罕见病治疗药品，以及社会关注度较高的阿尔茨海默病治疗药 品。 商保创新药目录的出台标志着医保与商保协同进入实质性阶段，开辟了一条市场化的支付通 道，提升了创新药可及性 "当化疗成为唯一选项时，我们需要的不仅是技术，更是支付的勇气。"一位鼻咽癌患者曾在其自述中如 是写道。这句话背后，是无数癌症患者面对天价创新药时的无奈——即便新药能带来生存希望，但高昂 的费用却让希望沦为奢望。这种困境在罕见病领域尤为突出，患者往往需自费承担数十万元甚至上百万 元的 ...

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 announced a strategic investment to acquire a controlling stake in Green Valley Pharmaceutical, investing approximately RMB 1.412 billion, which is seen as a high-risk bet in the Alzheimer's disease (AD) drug market [1][4]. Group 1: Transaction Details - The acquisition involves purchasing existing shares from current shareholders and subscribing to new registered capital, resulting in Fosun holding 51% of Green Valley [4]. - Fosun will pay RMB 143 million for existing shares and RMB 1.269 billion for new capital, primarily to support clinical research and daily operations [4]. - Green Valley is currently in a difficult financial position, with total assets of RMB 806 million and liabilities of RMB 795 million, leading to owner equity of only RMB 10.36 million [4]. Group 2: Product Focus - The key asset in this transaction is the controversial Alzheimer's drug, Ganluotena Capsules (marketed as "Jiuyiqi"), which has been halted due to regulatory issues [4][5]. - "Jiuyiqi" was conditionally approved in 2019 and had a significant market presence, benefiting over 500,000 patients after being included in medical insurance [5]. - The drug's unique mechanism has faced skepticism, and its clinical trials were prematurely terminated due to funding issues [5]. Group 3: Market Context - The AD market in China shows a significant unmet need, with nearly 17 million patients and a 242.5% increase in incidence from 1990 to 2021, indicating substantial growth potential [5][6]. - Fosun's existing portfolio includes other CNS assets, and "Jiuyiqi" could fill a gap in treatments for moderate AD patients, potentially creating an integrated diagnostic and therapeutic model [6]. Group 4: Strategic Implications - The transaction is viewed as a "low-cost acquisition," with Green Valley's total equity valued at RMB 1.674 billion, allowing Fosun to gain control at a significantly lower cost than previous investments [6]. - Fosun's management emphasizes the importance of addressing clinical needs in the CNS field and the potential for breakthroughs in AD drug development [6]. Group 5: Future Considerations - The success of this investment hinges on the ability to complete necessary post-marketing clinical trials and secure regulatory approvals for the drug's re-commercialization [6][7]. - The competitive landscape for AD treatments is intensifying, with international drugs gaining approval and recognition, posing challenges for "Jiuyiqi" to regain trust [7]. - The financial burden of Green Valley's liabilities will test Fosun's financial management capabilities [7].

编者按： 长期以来，我国创新药商业化面临着"进院难、支付难"的结构性困境，尤其是高值创新药，常常受限于 基本医保"保基本"的定位而难以纳入报销范围。此次政策组合拳的核心逻辑，在于通过明确的分工，厘 清了政府与市场的支付边界。 对外经济贸易大学创新与风险管理研究中心副主任龙格在接受采访时指出，《商保创新药目录》聚焦超 出基本医保保障范围，但临床价值显著的创新药，作为基本医保目录的补充。两者形成了"医保保基 本、商保接高端"的分工：基本医保覆盖基础药品，商保目录则满足多元化、高层次需求，并为创新药 提供"先商保后医保"的梯度准入路径。 具体而言，新版基本医保目录继续发挥"压舱石"作用。2025年医保目录新增114种药品，谈判/竞价成功 率高达88.19%，创下近七年新高。新增药品中，50种为1类创新药，重点覆盖肿瘤、慢性病、罕见病等 领域。调整后的目录内药品总数增至3253种，其中西药1857种、中成药1396种，极大地提升了重点领域 的用药保障水平。 与此同时，首版《商保创新药目录》则精准承接了基本医保"溢出"的高端需求。首批商保目录共纳入19 种药品，涵盖了CAR-T疗法、神经母细胞瘤和戈谢病等罕见病特效药以 ...