2026.01. 08 本文字数：3880，阅读时长大约6分钟 作者 | 第一财经 吴斯旻 今年1月1日起，首版商保创新药目录正式落地。在北京，与该目录同一天落地的是"第二批DRG付费 新药新技术除外支付名单"，纳入前述目录的达妥昔单抗β注射液赫然在列。 除外支付，更通俗地来说，就是对住院病例使用创新药的费用单独按实结算，不占用医保打包支付中 对应病组额度。 在国家医保局承诺对纳入商保创新药目录内药品执行的"三除外"政策中，"相关商业健康保险保障范 围内的创新药应用病例可不纳入按病种付费范围"被业界普遍视为对商保创新药目录内药品"进院"最 为利好也是最难执行的一条。 正如前述达妥昔单抗β注射液的案例，目前，北京、上海、浙江等省份为支持新药新技术应用而发布 的地方版激励清单中，已可见少数与商保创新药重叠的"身影"。但针对绝大多数商保创新药和更多医 保统筹地区，商保创新药的住院使用，仍面临与其他高倍率病例争夺特例单议名额的不确定性。 同时，创新药"进院"不仅仅要"进住院部"，也要"进门诊"。多名受访业界人士坦言，商保创新药的门 诊用药激励还处于政策空白阶段。 截至1月8日，据第一财经不完全统计，全国已有至少28个 ...

今年1月1日起，首版商保创新药目录正式落地。在北京，与该目录同一天落地的是"第二批DRG付费新 药新技术除外支付名单"，纳入前述目录的达妥昔单抗β注射液赫然在列。 除外支付，更通俗地来说，就是对住院病例使用创新药的费用单独按实结算，不占用医保打包支付中对 应病组额度。 在国家医保局承诺对纳入商保创新药目录内药品执行的"三除外"政策中，"相关商业健康保险保障范围 内的创新药应用病例可不纳入按病种付费范围"被业界普遍视为对商保创新药目录内药品"进院"最为利 好也是最难执行的一条。 正如前述达妥昔单抗β注射液的案例，目前，北京、上海、浙江等省份为支持新药新技术应用而发布的 地方版激励清单中，已可见少数与商保创新药重叠的"身影"。但针对绝大多数商保创新药和更多医保统 筹地区，商保创新药的住院使用，仍面临与其他高倍率病例争夺特例单议名额的不确定性。 同时，创新药"进院"不仅仅要"进住院部"，也要"进门诊"。多名受访业界人士坦言，商保创新药的门诊 用药激励还处于政策空白阶段。 截至1月8日，据第一财经不完全统计，全国已有至少28个省份明确当地定点医疗机构要在2月底前召开 药事会。 商保创新药"进院"细则待明确 要么纳入商 ...

Core Insights - The commercial insurance innovative drug directory has been officially implemented since January 1, with the inclusion of drugs like Daratumumab β injection, but outpatient incentives for these drugs remain in a policy vacuum [1][2] - The "three exclusions" policy is seen as a significant but challenging measure to facilitate the entry of commercial insurance innovative drugs into hospitals [1][3] - There is a lack of clarity regarding the implementation details for the entry of commercial insurance innovative drugs into hospitals, which limits the ability of medical institutions to stock a wider variety of these drugs [4][5] Group 1 - The first version of the commercial insurance innovative drug directory was launched on January 1, and it includes specific drugs that can be reimbursed separately from the bundled payment system [1] - As of January 8, at least 28 provinces have mandated local medical institutions to hold pharmacy meetings by the end of February to discuss the integration of commercial insurance innovative drugs [2] - The "three exclusions" policy aims to allow innovative drugs to be used in hospitals without affecting the bundled payment system, but its practical implementation remains uncertain [3][7] Group 2 - The entry of commercial insurance innovative drugs into hospitals can either be through inclusion in special drug directories or by facilitating their hospital entry pathways [3] - Recent data shows that from January 1 to 6, over 15 medical institutions recorded sales of commercial insurance innovative drugs, although most of these were pre-configured before the directory's release [3][4] - The sales of commercial insurance innovative drugs are highly concentrated in a few products, particularly those used for Alzheimer's treatment [3] Group 3 - There are currently no specific assessment indicators for the hospital configuration of commercial insurance innovative drugs, unlike the established metrics for national negotiated drugs [4] - Some provinces have clarified that the use of national negotiated drugs will not be included in certain performance assessment metrics for public medical institutions, but it is unclear if this applies to commercial insurance innovative drugs [5] - The transition from hospital entry to patient medication involves prescription and payment processes, which currently face significant bottlenecks, especially in outpatient settings [6] Group 4 - The "three exclusions" policy is expected to be crucial for expanding the hospital sales of commercial insurance innovative drugs, but balancing interests among stakeholders is necessary for effective implementation [7] - A common approach to support the use of innovative drugs in hospitals is to open a "special case negotiation" green channel, but the limited application quota raises concerns about accessibility for commercial insurance innovative drugs [8] - The implementation of "exclusion payment" mechanisms is seen as a more definitive incentive for hospitals to use innovative drugs, but current policies primarily favor national negotiated drugs [9] Group 5 - The commercial insurance innovative drug directory's initial week saw sales primarily occurring in medical institutions, but the market potential remains limited due to the nature of the drugs included [11] - There is a push for retail pharmacies to stock commercial insurance innovative drugs, but concerns about prescription practices and reimbursement processes persist [12] - Future efforts should focus on aligning the commercial insurance innovative drug directory with the national insurance system to enhance confidence in the use of these drugs in hospitals [12]

21世纪经济报道记者季媛媛上海报道 绿谷医药的母公司上海绿谷制药有限公司成立于1996年，主要从事中药天然药物和创新型糖类药物研发生产。这家企业聚焦阿尔茨海默病等领 域，历时22年研制出全球首个糖类多靶点抗阿尔茨海默病药物甘露特钠胶囊(商品名：九期一)，并于2019年通过国家优先审评程序获批上市， 成为2003年以来全球首个被批准的阿尔茨海默病新药。不过，与国际上主流的"β淀粉样蛋白"靶点假说不同，甘露特钠胶囊是以海洋褐藻提取 物为原料制备而成的低分子酸性寡糖化合物，是首个针对脑肠轴机制的AD新药。 同时，"附条件批准"意味着甘露特钠胶囊上市后需在规定期限内完成药物临床试验，并申请常规上市批准。 近日，阿尔茨海默病药物赛道异常热闹。在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 入选我国首版《商业健康保险创新药品目录》后，争议与机遇并存的国产阿尔茨海默病药物甘露特钠，在面临停产、换证危机之际，迎来了中 国医药巨头复星医药（600196）的入局。 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(上海)医药科技有限公司("绿 ...

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（上海）医药科技 有限公司（"绿谷医药"）及其现有相关股东共同签订相关投资协议，拟出资约人民币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（Alzheimer's disease，AD）。 在今年6月8日，绿谷被爆出将关闭甘露特钠胶囊相关的办公区、生产区。且早在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。我们正与有关部门紧密沟 通，全力以赴处理相关供货问题，以尽早满足患者迫切的治疗需求。"但该公告随后被删除。绿谷方面 更是多次被媒体报道近期面临严峻的经营压力，现金流极度紧张。 事实上，甘露特钠胶囊自2019年上市以来一直存在学术争议，其作用机制的相关论文，以及临床试验过 程、临床疗效等均受到质疑。此外，2022年5月，绿谷制药方面称，因疫情导致的临床试验 ...

（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 Points - The National Healthcare Security Administration and the Ministry of Human Resources and Social Security released the new National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog (2025) along with the first Commercial Health Insurance Innovative Drug Catalog (2025), focusing on high-innovation and clinically valuable drugs [1] - A total of 24 drugs participated in the price negotiation, with 19 successfully included, achieving a success rate of approximately 79% [1] - The included innovative drugs feature 5 CAR-T cell therapies, 6 rare disease drugs, and the only immune oncology drug in the commercial health insurance catalog [1] Group 1: CAR-T Cell Therapies - Five CAR-T cell therapies have been included in the commercial health insurance innovative drug catalog, which had previously attempted to enter the national insurance catalog four times without success [2][3] - The therapies included are from various companies, with the first approved CAR-T therapy being the Axicabtagene Ciloleucel injection from Fosun Kite [3] - Despite high treatment costs, the inclusion in the commercial catalog is expected to improve patient access and reduce financial burdens [3] Group 2: Oncology Drugs - The commercial health insurance innovative drug catalog includes a significant number of oncology drugs, with 14 drugs in total, accounting for nearly 74% of the catalog [5] - Notably, the CTLA-4 inhibitor Ipilimumab injection, the only immune oncology drug included, is expected to enhance treatment accessibility for liver cancer patients [6] Group 3: Rare Disease Drugs - The catalog also includes 6 innovative drugs for rare diseases, such as the drugs for neuroblastoma and phenylketonuria [8][10] - These drugs are aimed at addressing urgent patient needs and are part of a broader strategy to enhance treatment options for rare diseases [8] Group 4: Policy Implications - The establishment of the commercial health insurance innovative drug catalog is a significant step towards improving the multi-tiered medical insurance system in China [9] - The government encourages commercial health insurance providers to incorporate these drugs into their coverage, promoting a more comprehensive healthcare solution for patients [9]

Core Viewpoint - The new National Medical Insurance Directory and the first Commercial Health Insurance Innovative Drug Directory will be implemented nationwide starting January 1, 2026, providing a dual-track system for basic and innovative drug coverage [1][2]. Group 1: National Medical Insurance Directory - A total of 114 new drugs have been added to the National Medical Insurance Directory, with 111 being new products launched within the last five years, representing 97.3% of the new entries [2]. - Among the new additions, 50 are classified as Class 1 innovative drugs, with an overall success rate of 88%, an increase from 76% in 2024 [2]. - The total number of drugs in the directory has increased to 3,253, including 1,857 Western medicines and 1,396 traditional Chinese medicines [2]. Group 2: Company Announcements - Several listed companies, including Heng Rui Medicine and Fuxing Medicine, announced new drug entries or renewals in the National Medical Insurance Directory [3]. - Heng Rui Medicine reported that 20 products/indications were included in the new directory, with a projected sales revenue of approximately 8.66 billion yuan in 2024 and about 7.55 billion yuan in the first three quarters of 2025 [4]. - Hai Si Ke's two Class 1 innovative drugs were also included, with applications in sedation and pain management [6]. Group 3: Commercial Health Insurance Innovative Drug Directory - The first Commercial Health Insurance Innovative Drug Directory includes 19 new drugs from 18 innovative pharmaceutical companies, with 9 being Class 1 innovative drugs [11]. - Notably, 5 CAR-T products were included, representing over half of the CAR-T products available in China, addressing previous challenges in pricing negotiations [11][12]. - The directory also includes treatments for rare diseases and high-profile conditions such as Alzheimer's disease, enhancing the coverage provided by basic medical insurance [11][13].

Core Insights - The 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog and the first Commercial Health Insurance Innovative Drug Catalog were officially released on December 7, highlighting significant advancements in drug accessibility and innovation support [1][6]. Summary by Sections Basic Medical Insurance Drug Catalog - A total of 114 new drugs were added, with 50 being first-class innovative drugs, achieving an overall success rate of 88%, an increase from 76% in 2024 [3][5]. - The total number of drugs in the National Medical Insurance Drug Catalog has increased to 3,253, including 1,857 Western medicines and 1,396 traditional Chinese medicines, with enhanced coverage for critical areas such as cancer, chronic diseases, mental illnesses, rare diseases, and pediatric medications [3][5]. - The new drug catalog will be implemented starting January 1, 2026, with a six-month transition period for drugs that were not successfully renewed [3][4]. Commercial Health Insurance Innovative Drug Catalog - The Commercial Health Insurance Innovative Drug Catalog includes 19 drugs from 18 innovative pharmaceutical companies, focusing on high clinical value and innovation, particularly in cancer, rare diseases, and chronic conditions [7][9]. - The catalog emphasizes three main characteristics: support for innovation, focus on key therapeutic areas, and a clear distinction between basic medical insurance and commercial insurance coverage [7][9]. - Notable inclusions are five CAR-T products and new treatments for Alzheimer's disease and Gaucher disease, reflecting a trend towards covering high-cost, innovative therapies through commercial insurance [8][9]. Innovation and Market Impact - The inclusion of a significant number of first-class innovative drugs in the basic medical insurance catalog demonstrates the government's commitment to enhancing drug accessibility and encouraging pharmaceutical innovation [6][9]. - The successful negotiation rates and the focus on innovative drugs in both catalogs are expected to stimulate further investment in drug research and development by pharmaceutical companies [6][9].

Core Insights - The release of the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalogs marks a significant step in enhancing drug accessibility and innovation in China, with a total of 114 new drugs added to the basic insurance catalog, including 50 innovative drugs, achieving an overall success rate of 88%, up from 76% in 2024 [1][5][9]. Summary by Sections Basic Medical Insurance Drug Catalog - A total of 114 new drugs were successfully added, with 50 classified as innovative drugs, reflecting an overall success rate of 88% [5][9]. - The total number of drugs in the national insurance catalog now stands at 3,253, including 1,857 Western medicines and 1,396 traditional Chinese medicines, with significant improvements in coverage for critical areas such as cancer, chronic diseases, mental health, rare diseases, and pediatric medications [5][9]. - The catalog includes drugs that fill gaps in basic insurance coverage, such as treatments for triple-negative breast cancer, pancreatic cancer, and other major diseases [9]. Commercial Health Insurance Innovative Drug Catalog - The first edition of the Commercial Health Insurance Innovative Drug Catalog includes 19 drugs, with a focus on high clinical value and innovation, particularly in oncology, rare diseases, and chronic conditions [11][12]. - Notable inclusions are CAR-T therapies and treatments for rare diseases like neuroblastoma and Gaucher disease, as well as Alzheimer's disease medications [11][12]. - The catalog emphasizes the distinction between basic insurance, which focuses on essential and proven therapies, and commercial insurance, which supports cutting-edge innovations [11][12]. Future Implications - The introduction of these catalogs is expected to enhance clinical medication standards and boost confidence in pharmaceutical R&D, ensuring better healthcare and injury treatment for the public [8]. - The ongoing adjustments to the drug catalogs reflect a commitment to improving the accessibility of innovative drugs and encouraging pharmaceutical companies to invest in research and development [10][11].