2025.12. 15 阿尔茨海默病是一种中枢神经系统退行性疾病，以渐进性记忆障碍及认知功能减退伴日常生活能力下 降和行为改变为特征，是全球需应对的公共卫生领域重大疾病之一。当前，阿尔茨海默病的治疗手段 十分有限，尚无治愈方法，存在巨大的未被满足的临床需求。 绿谷医药旗下的甘露特钠胶囊，曾在2019年11月获得国家药监局有条件批准，用于轻度至中度阿尔 茨海默病，改善患者认知功能。 本文字数：961，阅读时长大约2分钟 作者 | 第一财经 林志吟 因阿尔茨海默病（AD）药物"九期一"注册证到期而陷入停产的绿谷（上海）医药科技有限公司 （"绿谷医药"），迎来了接盘方。 12月15日，复星医药（600196.SH；02196.HK）宣布，控股子公司复星医药产业与绿谷医药及其 现有相关股东共同签订相关投资协议，拟出资约14.12亿元控股收购绿谷医药。 本次收购完成后，绿谷医药将成为复星医药控股子公司，其核心药品甘露特钠胶囊（商品名"九期 一"）也将纳入复星医药创新药品管线，主要用于治疗轻度至中度阿尔茨海默病（AD）。 微信编辑 | 小羊 第 一 财 经 持 续 追 踪 财 经 热 点 。 若 您 掌 握 公 司 动 ...

因阿尔茨海默病（AD）药物"九期一"注册证到期而陷入停产的绿谷（上海）医药科技有限公司（"绿谷 医药"），迎来了接盘方。 12月15日，复星医药（600196.SH；02196.HK）宣布，控股子公司复星医药产业与绿谷医药及其现有相 关股东共同签订相关投资协议，拟出资约14.12亿元控股收购绿谷医药。 本次收购完成后，绿谷医药将成为复星医药控股子公司，其核心药品甘露特钠胶囊（商品名"九期一"） 也将纳入复星医药创新药品管线，主要用于治疗轻度至中度阿尔茨海默病（AD）。 阿尔茨海默病是一种中枢神经系统退行性疾病，以渐进性记忆障碍及认知功能减退伴日常生活能力下降 和行为改变为特征，是全球需应对的公共卫生领域重大疾病之一。当前，阿尔茨海默病的治疗手段十分 有限，尚无治愈方法，存在巨大的未被满足的临床需求。 绿谷医药旗下的甘露特钠胶囊，曾在2019年11月获得国家药监局有条件批准，用于轻度至中度阿尔茨海 默病，改善患者认知功能。 复星医药方面表示，目前，研究团队正在积极开展甘露特钠胶囊上市后确证性临床试验。本次收购完成 后，复星医药将携绿谷医药团队在药品审评部门的指导下，有序严谨推进上市后确证性临床试验，以期 尽快实 ...

绿谷医药旗下的甘露特钠胶囊，曾在2019年11月获得国家药监局有条件批准，用于轻度至中度阿尔茨海 默病，改善患者认知功能。 然而，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，要求继 续完成正在进行的上市后确证性临床研究。因注册批件到期，2024年11月起，该药品未开展商业化生 产。 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。 复星医药方面表示，目前，研究团队正在积极开展甘露特钠胶囊上市后确证性临床试验。本次收购完成 后，复星医药将携绿谷医药团队在药品审评部门的指导下，有序严谨推进上市后确证性临床试验，以期 尽快实现获批；并适时开展相关适应证的国际多中心临床试验，惠及更多阿尔茨海默病患者。 绿谷医药将成为复星医药控股子公司。 因阿尔茨海默病（AD）药物"九期一"注册证到期而陷入停产的绿谷（上海）医药科技有限公司（"绿谷 医药"），迎来了接盘方。 12月15日，复星医药（600196.SH；021 ...

复星医药（600196）(600196.SH)公告，公司控股子公司复星医药产业拟出资共计14.12亿元控股投资绿 谷医药。本次认购新增注册资本之款项将由标的集团用于临床研究及日常运营。根据约定，本次收购包 括： 2、复星医药产业拟出资12.69亿元认缴标的公司2.01亿元新增注册资本。 1、复星医药产业拟出资1.43亿元受让转让方(即市隐投资、识璧润咨询)合计持有的标的公司2015万元注 册资本。 本次收购完成后，集团将持续有序推进该药品的上市后确证性临床试验，以使该药品尽快获得国家药品 审评部门批准;此外，集团也将适时启动该药品相关适应症的国际多中心临床研究，以期惠及更多阿尔 茨海默病患者。 3、此外，为妥善处理标的公司存续股权激励计划等安排中相关退股并由投资方和创始人共同承担相应 成本，拟由标的公司先行向约定范围内的退股员工等支付相应退股款项，同时由标的公司现有股东上海 耀期九(由创始人实际控制)于本次认购交割日前以1元或法律允许的最低对价向由复星医药产业与标的 公司创始人或其关联方拟共同设立的SPV(双方分别持股51%、49%)转让所持有的标的公司866.7347万元 注册资本(即"阶段性转让");后续 ...

Core Viewpoint - The announcement of the largest Alzheimer's disease registration study in China has been made by Wanbangde, focusing on the clinical trial of its new drug, Huperzine A controlled-release tablets, for treating mild to moderate Alzheimer's disease [1][3]. Group 1: Drug Development and Clinical Trials - Wanbangde's subsidiary has completed the enrollment of 50 subjects for the Phase II/III clinical trial of Huperzine A controlled-release tablets, which received approval for the key registration trial in July [1][2]. - The drug is designed to improve cognitive function and has shown potential in preclinical studies to slow the progression of Alzheimer's disease, with benefits including the reduction of β-amyloid protein, anti-inflammatory effects, and neuroprotection [2][3]. - The controlled-release technology used in the formulation allows for a smoother drug release profile, enhancing patient compliance and safety by enabling once-daily dosing [2]. Group 2: Company Background and Market Position - Wanbangde is based in Taizhou, Zhejiang, a significant hub for raw material drug production in China, and focuses on the pharmaceutical manufacturing and healthcare industry, covering various therapeutic areas including cardiovascular, neurological, respiratory, digestive, and mental health [1]. - The company has established a reputation in the neurological treatment field, with its Huperzine A injection recognized as a first-line medication for memory disorders caused by dementia and other brain conditions [1][2].

（原标题：年费超10万的老年痴呆症新药，首次进商保） 无论是卫材公司的仑卡奈单抗还是礼来的多奈单抗，患者一年的治疗费用均需超过10万元。高昂的治疗 费用一度让不少阿尔茨海默病（AD）患者家庭在希望与绝望间徘徊，直到首版商保创新药目录为这种 困境带来了转机。 日前，在2025创新药高质量发展大会上，我国首版《商业健康保险创新药品目录》正式发布。两款近年 来最具突破性的阿尔茨海默病对因治疗药物——仑卡奈单抗注射液和多奈单抗注射液双双入选。而被纳 入商保目录的两款AD药物，都代表了当前阿尔茨海默病治疗领域的最高水平。 AD，作为老龄化社会中的"沉默杀手"，国内患者数量已超1000万。然而，过去由于药物疗效有限且价 格高昂，其临床使用率一直极低。眼下，商保目录意味着，政策在破局。在商保目录推动下， 全球阿 尔茨海默病治疗市场正在经历一场深刻变革。 ...

Core Viewpoint - The inclusion of innovative Alzheimer's disease (AD) treatments, Lecanemab and Donanemab, in China's first commercial health insurance innovative drug directory marks a significant shift towards a multi-layered payment model, enhancing accessibility and affordability for high-cost treatments [1][2][3] Group 1: Policy and Market Changes - The National Healthcare Security Administration has introduced a commercial health insurance innovative drug directory to address the high costs of breakthrough drugs, allowing for a collaborative payment approach between public insurance and commercial health insurance [3][11] - The first version of the commercial insurance directory includes 19 drugs, with a focus on high-innovation and high-clinical-value treatments, including the two AD drugs, which represent the highest level of current AD treatment [3][10] - The shift from a single public insurance model to a "public + commercial insurance" model is expected to lower out-of-pocket costs for patients and stimulate demand for AD treatments [2][11] Group 2: Economic Impact and Patient Accessibility - The economic burden of AD in China is substantial, with annual costs reaching 1.1 trillion RMB in 2015, projected to rise to 3.2 trillion RMB by 2030 and 11.9 trillion RMB by 2050 [5][6] - Early diagnosis rates for AD are low, with 95% of patients diagnosed at moderate to severe stages, highlighting the need for improved screening and treatment pathways [5][6] - The commercial insurance directory is seen as a catalyst for transforming the global AD treatment market, with the market size expected to grow from 23 billion RMB in 2020 to 25.7 billion RMB by 2026, reflecting a compound annual growth rate of 1.5% [7][8] Group 3: Research and Development Landscape - The development of new AD drugs is a lengthy and costly process, averaging 10.5 years and requiring approximately $2.6 billion in investment, with many candidates failing at various stages [8][10] - Current AD treatments in China include cholinesterase inhibitors and NMDA receptor antagonists, with the recent inclusion of innovative drugs expected to reshape the competitive landscape [8][10] - The recent failures of major pharmaceutical companies in clinical trials have not deterred investment in AD research but have instead accelerated the evolution of the treatment ecosystem [9][10] Group 4: Future Directions and Challenges - Despite the progress made with the inclusion of AD drugs in the insurance directory, barriers remain, such as the need for a multi-layered payment model that combines basic insurance, commercial insurance, and special funds for low-income patients [11] - Establishing a dedicated AD patient database could facilitate faster efficacy validation and expand indications, reducing R&D risks for pharmaceutical companies [11] - The increasing prevalence of AD with age necessitates refined risk control mechanisms to ensure that innovative treatments are both accessible and affordable for patients [11]

Core Insights - The introduction of the first Commercial Health Insurance Innovative Drug Directory in China marks a significant step towards improving the accessibility of high-cost Alzheimer's disease (AD) treatments, specifically the drugs Lecanemab and Donanemab, which each cost over 100,000 yuan annually [1][2][3] Group 1: Policy Developments - The National Healthcare Security Administration has responded to the high costs of innovative drugs by establishing a Commercial Health Insurance Innovative Drug Directory, which includes drugs with high innovation and clinical value that exceed basic insurance coverage [3][11] - The directory aims to create a multi-layered medical security system that combines commercial health insurance with basic medical insurance to enhance the affordability and accessibility of innovative therapies for major diseases [1][2] Group 2: Market Dynamics - The inclusion of Lecanemab and Donanemab in the insurance directory signifies a shift from a single reliance on basic medical insurance to a layered payment model of "medical insurance + commercial insurance," which opens new pathways for the accessibility of high-priced innovative drugs [2][11] - The global Alzheimer's drug market was valued at 23 billion yuan in 2020 and is projected to reach 25.7 billion yuan by 2026, indicating a compound annual growth rate of 1.5% [7] Group 3: Economic Impact - The societal value of early AD treatment could reach up to 5.5 trillion USD (approximately 35.48 trillion yuan) from 2021 to 2041 in the U.S., highlighting the significant economic burden of AD on families and society [4] - In China, the average annual cost for AD patients reached 1.1 trillion yuan in 2015, accounting for 1.47% of the GDP, with projections indicating that this cost could rise to 3.2 trillion yuan by 2030 and 11.9 trillion yuan by 2050 [5][6] Group 4: Clinical and Research Landscape - The current treatment landscape for AD includes various drugs, but the two newly included drugs represent the highest level of treatment available for the disease [3][8] - Despite the advancements, the early diagnosis rate for AD in China remains low, with 95% of patients diagnosed at moderate to severe stages, indicating a need for improved early screening and diagnosis [5][6] Group 5: Future Considerations - The establishment of the Commercial Health Insurance Innovative Drug Directory is seen as a policy breakthrough that could reshape the global AD treatment market, transitioning competition from mere drug efficacy to a broader ecosystem competition [9][10] - There are still barriers to overcome, such as the need for a multi-layered payment model and the establishment of a specialized database for AD to facilitate faster efficacy validation and pricing strategies [11]

Core Viewpoint - The inclusion of innovative Alzheimer's disease (AD) treatments, Lecanemab and Donanemab, in China's first commercial health insurance innovative drug directory marks a significant breakthrough in the payment model for high-cost treatments, transitioning from a single reliance on public insurance to a "public + commercial" layered payment system [2][6][10]. Group 1: Policy and Market Impact - The release of the first commercial health insurance innovative drug directory at the 2025 Innovative Drug High-Quality Development Conference includes two groundbreaking AD treatments, reflecting a critical step in enhancing the accessibility of innovative drugs within China's multi-tiered healthcare system [1][6]. - The new policy aims to alleviate the financial burden on patients by leveraging the flexibility of commercial insurance, which can provide customized coverage and complement public insurance, thereby reducing out-of-pocket expenses for patients [4][6]. - The commercial insurance directory includes 19 drugs, with a focus on high-innovation and high-clinical-value treatments, indicating a shift in the healthcare landscape towards supporting innovative therapies [6][10]. Group 2: Economic and Social Implications - The economic burden of AD in China is substantial, with annual costs for patients reaching approximately 1.1 trillion RMB in 2015, projected to rise to 3.2 trillion RMB by 2030 and 11.9 trillion RMB by 2050, highlighting the urgent need for effective treatment options [9][10]. - The low early diagnosis rate of AD in China, with 95% of patients diagnosed at moderate to severe stages, underscores the necessity for improved screening and treatment protocols to enhance early intervention [8][9]. - The introduction of the commercial insurance directory is expected to stimulate demand for AD treatments, promoting early diagnosis and standardized treatment practices, which are essential for addressing the public health challenges posed by an aging population [4][10]. Group 3: Research and Development Landscape - The development of new AD drugs is a lengthy and costly process, averaging 10.5 years and requiring approximately 2.6 billion USD, with many candidates failing at various stages of clinical trials [12][14]. - Despite the challenges, the competitive landscape for AD treatments is evolving, with domestic companies rapidly advancing their research efforts, while international firms continue to seek market entry in China [15][16]. - The recent failures of major pharmaceutical companies in clinical trials have not deterred investment in AD research; instead, they have accelerated the transformation of the AD treatment ecosystem, shifting focus from mere drug competition to a broader ecological competition [14][15].

Summary of ProMIS Neurosciences FY Conference Call Company Overview - **Company**: ProMIS Neurosciences (NasdaqCM:PMN) - **Focus**: Development of novel drugs for Alzheimer's disease, specifically targeting amyloid beta oligomers Industry Insights - **Alzheimer's Disease Landscape**: - Current treatments have a risk-benefit profile that is not favorable, leading to challenges in prescription by physicians [2][3] - There is a significant opportunity for novel drugs that effectively target the harmful species of amyloid beta [3] Key Developments - **Clinical Trials**: - ProMIS is conducting a Phase 1b trial for its lead compound, PMN310, an amyloid beta monoclonal antibody [4][6] - The trial is on track for complete enrollment of 128 patients by the end of the year, with an interim analysis expected in Q2 of the following year [4][5][19] - Final top-line results are anticipated in Q4 of next year [5] Product Differentiation - **Targeting Strategy**: - PMN310 focuses on low molecular weight oligomers of amyloid beta, which are believed to be the most toxic and drive disease progression [10][14] - The industry has shifted away from targeting plaque forms of amyloid beta due to limited clinical benefits [9][10] Safety Profile - **Safety and Efficacy**: - The trial has shown a clean safety profile to date, with expectations to maintain low levels of ARIA (Amyloid-related imaging abnormalities) incidents [16][18] - The dropout rate in the trial is significantly lower than in other studies, indicating strong patient retention [15] Biomarker Analysis - **Interim Analysis**: - The interim analysis will focus on safety, biomarkers, and clinical endpoints, with specific biomarkers like pTau217 and neurogranin being key indicators of disease progression and neuroinflammation [20][21] - A recent study highlighted the predictive value of pTau217 for clinical outcomes, which may influence future regulatory considerations [22][25] Regulatory Considerations - **FDA Approval Pathway**: - The FDA has moved away from approving drugs based solely on plaque reduction, emphasizing the need for clinically validated endpoints [24][25] - There is uncertainty regarding whether pTau217 will be accepted as a valid biomarker for approval, as the FDA may continue to prioritize clinical endpoints [25][26] Future Directions - **Potential for Subcutaneous Delivery**: - The decision to pursue a subcutaneous formulation will likely be made after the interim analysis, depending on the efficacy and safety data [40][41] - The current formulation allows for monthly dosing, and if successful, a subcutaneous option could be developed in parallel with ongoing studies [41][42] Conclusion - ProMIS Neurosciences is positioned to potentially make significant contributions to the Alzheimer's treatment landscape with its innovative approach to targeting amyloid beta oligomers. The upcoming interim analysis and final results will be critical in determining the future trajectory of PMN310 and its market positioning.