12月7日上午，2025创新药高质量发展大会在广州召开。会议发布了2025年《国家基本医疗保险、生育 保险和工伤保险药品目录》以及备受瞩目的首版《商业健康保险创新药品目录》。 此次"双目录"的发布，标志着我国在构建多层次医疗保障体系、支持创新药产业发展方面迈出关键一 步。 医保覆盖面持续扩大 《证券日报》记者从现场获悉，调整后的国家医保药品目录内药品总数已增至3253种，其中西药1857 种、中成药1396种。 其中，2025年国家医保药品目录纳入了一些弥补基本医保保障空白的药品，涵盖三阴乳腺癌、胰腺癌、 肺癌等重大疾病用药；朗格汉斯细胞组织细胞增生症、螯合剂不耐受的地中海贫血症等罕见病用药；以 及糖尿病、高胆固醇血症、自身免疫性疾病等慢性病用药。 具体到企业，信达生物制药集团共有七款创新产品(含新增适应症)被纳入2025年版国家医保药品目录， 包括达伯舒®（信迪利单抗注射液，抗PD-1单克隆抗体)新增适应症、信必敏®（替妥尤单抗N01注射 液，抗IGF-1R单克隆抗体)、奥壹新®（利厄替尼片，EGFR TKI)等；江苏恒瑞医药股份有限公司也有 10款产品首次进入医保、5款产品新增适应症进入医保，另有5款产品 ...

医保准入已成为创新药市场放量的关键节点。数据显示，进入医保目录的创新药，通常能在一年内实现 销售额的快速增长。这种"以价换量"的模式，正在重塑中国创新药企业的商业模式。 2026年1月1日起，中国医保目录将迎来历史上规模最大的一次创新药扩容。 12月7日，国家医保局披露，经相应程序，本次目录调整新增114种药品，其中50种1类创新药，同时调 出了29种临床没有供应或可被其他药物更好替代的药品（其中9种尚有相同治疗主成分的其他剂型在目 录内，不减少目录编号）。本次调整后，目录内药品总数增至3253种，其中西药1857种、中成药1396 种，肿瘤、慢性病、精神疾病、罕见病、儿童用药等重点领域的保障水平得到明显提升。新版医保目录 将于2026年1月1日起正式实施。 21世纪经济报道记者梳理发现，此次创新药入医保成为趋势。例如，恒瑞医药共有11款抗肿瘤产品成功 纳入，包括5款首次纳入国家医保目录的创新产品，即注射用瑞康曲妥珠单抗（艾维达®）、注射用磷 罗拉匹坦帕洛诺司琼（瑞坦宁®）、苹果酸法米替尼胶囊（艾比特®）、醋酸阿比特龙片（Ⅱ）（艾瑞 吉®）和盐酸伊立替康脂质体注射液（Ⅱ）（越优力®）。除新增纳入的创新药外，恒 ...

相关概念股： 绿叶制药(02186)：公司发布公告，集团共有五款新产品成功纳入由国家医疗保障局发布的《国家基本 医疗保险、生育保险和工伤保险药品目录(2025年)》(国家医保药品目录)或《商业健康保险创新药品目 录(2025年)》(商保创新药目录)。该五款新产品包括：米美欣®(羟考酮纳洛酮缓释片)、瑞百莱®(棕榈酸 帕利哌酮注射液(Ⅱ))首次纳入国家医保药品目录;赞必佳®(注射用芦比替定)成功入选商保创新药目录;百 拓维®(注射用戈舍瑞林微球)、瑞可妥®(注射用利培酮微球(Ⅱ))顺利续约，继续被纳入国家医保药品目 录。 本次目录调整新增114种药品，其中50种1类创新药，同时调出了29种临床没有供应或可被其他药物更好 替代的药品。新版国家医保药品目录纳入了一些弥补基本医保保障空白的药品，如三阴乳腺癌、胰腺 癌、肺癌等重大疾病用药;朗格汉斯细胞组织细胞增生症、螯合剂不耐受的地中海贫血症等罕见病用药; 糖尿病、高胆固醇血症、自身免疫性疾病等慢性病用药。 基本医保目录新增药品中，有50种是一类创新药，总体成功率88%，较2024年的76%明显提高。 在商保创新药目录协商环节中，备受市场高度关注的五款CAR-T品种全 ...

此次发布标志着我国在构建多层次医疗保障体系、支持创新药产业发展方面迈出关键一步 具体到企业，信达生物制药集团共有七款创新产品（含新增适应症）被纳入2025年版国家医保药品目 录，包括达伯舒®（信迪利单抗注射液，抗PD-1单克隆抗体）新增适应症、信必敏®（替妥尤单抗N01 注射液，抗IGF-1R单克隆抗体）、奥壹新®（利厄替尼片，EGFRTKI）等；江苏恒瑞医药股份有限公 司也有10款产品首次进入医保、5款产品新增适应症进入医保，另有5款产品完成目录内续约，覆盖肿 瘤、代谢、心血管疾病、免疫系统疾病、眼科等多个领域。 值得一提的是，此次会议还推出了首版《商业健康保险创新药品目录》，该目录主要聚焦于创新程度 高、临床价值大、患者获益显著，但因价格较高超出"保基本"定位而暂时无法纳入基本医保目录的药 品。 此次共纳入19种药品，包括CAR-T等前沿肿瘤治疗药品，神经母细胞瘤、戈谢病等罕见病治疗药品，以 及社会关注度极高的阿尔茨海默病治疗药品等。 国家医保局医药服务管理司司长黄心宇表示，与城乡居民基本医保超过95%的资金使用率相比，商业健 康保险由于销售佣金、核保理赔、费用管控、风险监管等方面的成本较高，在保障效能上 ...

Core Viewpoint - The upcoming adjustment to China's medical insurance catalog, effective January 1, 2026, will be the largest expansion of innovative drugs in history, adding 114 new drugs, including 50 class 1 innovative drugs, reflecting a significant commitment to support innovation in the pharmaceutical sector [2][11]. Summary by Sections Medical Insurance Directory Adjustment - The total number of drugs in the medical insurance directory will increase to 3,253, with a notable enhancement in coverage for key areas such as oncology, chronic diseases, mental health, rare diseases, and pediatric medications [2]. - The proportion of innovative drugs in the directory is rising, with 50 out of 114 new additions being class 1 innovative drugs, accounting for nearly 44% [2][11]. Innovative Drug Market Dynamics - The inclusion of innovative drugs in the medical insurance directory is a critical factor for market expansion, as these drugs typically experience rapid sales growth within a year of being added [5]. - Companies like Heng Rui Medicine and Innovent Biologics have successfully included multiple innovative products in the new directory, indicating a trend towards greater access to innovative treatments [6][7]. Clinical Demand and Treatment Options - The new directory focuses on drugs with significant clinical value and urgent patient needs, particularly in oncology, where new treatments for blood cancers and breast cancer have been added [12][14]. - The inclusion of targeted therapies for severe asthma and diabetes reflects a commitment to addressing pressing health issues in the population [10][8]. Pricing and Insurance Collaboration - A new commercial insurance directory for innovative drugs has been established, which includes 19 innovative drugs from 18 companies, aiming to create a balanced payment mechanism between basic medical insurance and commercial insurance [19][23]. - The commercial insurance directory is expected to alleviate the financial burden on patients, particularly for high-cost treatments like CAR-T therapy [21][22]. Policy Coordination and Future Outlook - The development of innovative drugs requires coordinated policies across drug approval, medical insurance, and clinical application, which have seen significant reforms in recent years [25][26]. - The future of innovative drug development in China hinges on the collaboration between industry policies and capital markets, with expectations for more original innovations and a focus on global competitiveness [27][28]. Conclusion - The adjustment of the medical insurance directory marks a transformative step for innovative drugs in China, shifting from being luxury items to accessible treatment options for a broader population, ultimately enhancing patient outcomes and supporting the goal of universal health coverage [29].

创新药板块，迎来利好消息！ 据悉，2025年国家医保药品目录成功新增114种药品，有50种是一类创新药，总体成功率88%，较2024 年的76%明显提高；另外，有19种药品纳入首版商保创新药目录，包括CAR-T类、T细胞治疗等先进治 疗手段，也有短肠综合征、戈谢病等基本医保暂时无法解决的罕见病治疗药物。 国家医保局、人力资源社会保障部表示，要积极推进商保创新药目录药品配备使用，积极推动商保创新 药目录纳入商业健康保险保障范围。 两部门重磅发布 12月7日，国家医保局、人力资源社会保障部印发《国家基本医疗保险、生育保险和工伤保险药品目 录》以及《商业健康保险创新药品目录》（2025年）。 其中提到，新版药品目录自2026年1月1日起正式执行，《国家基本医疗保险、工伤保险和生育保险药品 目录（2024年）》（医保发〔2024〕33号）同时废止。各地要严格执行新版药品目录，不得自行调整目 录内药品品种、备注、甲乙分类等内容。要及时更新信息系统和数据库，将新增的医保目录药品按规定 纳入，调出的药品按规定删除，调整"备注"内容的药品要更新支付范围，同步做好药品编码数据库与智 能监管子系统的对接，落实新版药品目录管理要求 ...

Core Viewpoint - The release of the 2025 National Medical Insurance Drug List and the first version of the Commercial Health Insurance Innovative Drug List marks a significant advancement for the innovative drug sector, with a total of 114 new drugs added, including 50 class-one innovative drugs, reflecting an overall success rate of 88%, an increase from 76% in 2024 [1][4]. Group 1: New Drug Additions - The 2025 National Medical Insurance Drug List includes 114 new drugs, of which 50 are classified as class-one innovative drugs [4]. - The new list also incorporates treatments for major diseases such as triple-negative breast cancer, pancreatic cancer, and lung cancer, as well as rare diseases and chronic conditions [5]. - A total of 19 drugs have been included in the first version of the Commercial Health Insurance Innovative Drug List, featuring advanced therapies like CAR-T and T-cell treatments [1][5]. Group 2: Implementation and Management - The new drug lists will take effect on January 1, 2026, and the previous 2024 drug list will be abolished [2]. - Local health insurance departments are required to guide medical institutions in the proper allocation and use of the newly listed drugs, ensuring compliance with the updated drug directory [3]. - A six-month transition period will be provided for drugs that were not successfully renewed in the directory, allowing for continued payment at original rates until June 2026 [2][3]. Group 3: Commercial Health Insurance Integration - Efforts are being made to integrate the Commercial Health Insurance Innovative Drug List into multi-tiered medical insurance systems, promoting the development of inclusive commercial health insurance [3]. - Insurance companies are encouraged to design new products and adjust compensation methods based on the innovative drug list to better meet patient needs [3][5]. - The innovative drug directory serves as a recommendation, and further details on which insurance providers will cover these drugs are pending [5]. Group 4: Market Outlook - The innovative drug sector is expected to continue its upward trend, with recent adjustments in the drug directory enhancing investment opportunities in related pharmaceutical companies [6][7]. - The market has seen a period of adjustment, positioning stock prices and market expectations at relatively reasonable levels, highlighting the investment safety margin and return potential [6][7].

Core Insights - The company Innovent Biologics has successfully included seven innovative products in the newly released 2025 National Medical Insurance Directory, which includes the PD-1 inhibitor, Tyvyt® (sintilimab injection) and other mature products with expanded indications [1] Group 1: Product Inclusion - The newly added indications for Tyvyt® mean that all eight approved indications are now covered by medical insurance [1] - The directory also includes several recently launched new drugs targeting oncology and chronic diseases, such as China's first approved KRAS G12C inhibitor, Elunate® (fruquintinib), and the IGF-1R antibody drug, IBI310 (tislelizumab) [1] Group 2: Market Position - Currently, Innovent Biologics has a total of 17 innovative drugs on the market, with 12 of them included in the National Medical Insurance Directory [1]

Investment Rating - The investment rating for the company is "Buy" and is maintained [8]. Core Insights - The company achieved its first Non-IFRS profit in 2024, with total revenue of 9.42 billion RMB (up 51.8% year-on-year), product revenue of 8.23 billion RMB (up 43.6% year-on-year), net profit of 330 million RMB, EBITDA of 410 million RMB, and a gross margin of 84.9% (up 2.1% year-on-year). The sales and administrative expense ratio decreased to 50.9% (down 7.1% year-on-year), with cash on hand of 10.22 billion RMB and R&D investment of 2.5 billion RMB [2][5][8]. Summary by Sections Financial Performance - In 2024, the company reported a total revenue of 9.42 billion RMB, marking a 51.8% increase year-on-year. Product revenue reached 8.23 billion RMB, reflecting a 43.6% year-on-year growth. The net profit was 330 million RMB, with an EBITDA of 410 million RMB and a gross margin of 84.9% [2][5][8]. Strategic Goals - The company has set clear strategic goals for the next decade, aiming for a product revenue of 20 billion RMB by 2027 and plans for five pipelines to enter global multi-center Phase III clinical trials by 2030 [8]. Product Development - The company has seen significant growth in new products, with strong sales performance from its main products, including 达伯舒® (信迪利单抗注射液) and others. The product portfolio is expanding with new targeted drugs, including 达伯特® (KRAS G12C) and others. Notable new drug approvals include 信必乐® and 信必敏® [8]. Long-term Growth Drivers - The long-term growth is driven by the oncology and comprehensive product lines, with expectations of reaching 20 billion RMB in product revenue by 2027. The company plans to leverage at least 20 approved products and expand into new clinical innovations and indications [8]. Profit Forecast - The company forecasts net profits of 631 million RMB, 1.142 billion RMB, and 1.570 billion RMB for 2025, 2026, and 2027 respectively, with corresponding EPS of 0.38 RMB, 0.69 RMB, and 0.95 RMB [8].