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 ...

12月7日，国家医保局发布《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）。据统计，本次医保目录调整共有114种药品新增进入、29种药调出，另有 18家企业的19种药品进入商保创新药目录，并决定于2026年1月1日起正式执行，这也是医保目录调整中 首次同步推出商保创新药目录，形成基本医保与商业健康保险协同保障创新药的双轨格局。 此次调整中，奥赛康(002755)自主研发生产的1类创新药奥壹新®（通用名：利厄替尼片）成功通过谈 判，被正式纳入国家医保目录，有望显著减轻患者经济负担，提升临床可及性。 据了解，奥壹新®是具有自主知识产权、全新分子实体、活性显著的口服的第三代EGFR-TKI。目前已 获批两项肺癌适应症，实现对不同治疗阶段患者的精准覆盖，作为结构差异化的新型第三代 EGFR- TKI，奥壹新®不仅具备强效的肿瘤抑制活性，更在临床中展现出突出的脑转移治疗优势——这对肺癌 患者至关重要，因为脑转移是EGFR突变NSCLC患者常见的转移部位，也是影响患者生存期与生活质量 的重要因素。临床研究证实，奥壹新®在延长患者无进展生存期的同时，能有效提升生活质量，为肺癌 ...

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 ...

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].

Regulatory Developments - The National Health Commission and other departments have released the 2025 National Random Supervision and Inspection Plan, which includes new regulatory areas such as internet diagnosis and treatment, and mental health, while explicitly targeting online medical fraud [1] - The regulatory focus on combating online medical fraud represents a significant upgrade in medical supervision, aiming to purify the medical online space [1] Pharmaceutical Approvals - Innovent Biologics announced that its third-generation EGFR TKI drug, Olitinib (Leratinib), has received approval from the National Medical Products Administration (NMPA) for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations [2] - Olitinib is the only approved third-generation EGFR TKI based on a naphthalene structure, expanding treatment options for EGFR mutation-positive NSCLC patients [2] Market Regulation and Antitrust Issues - Xianju Pharmaceutical is facing a potential fine of approximately 195 million yuan for alleged monopolistic practices related to the pricing of dexamethasone phosphate raw materials, with the case still under review by the Tianjin Market Supervision Administration [3] - This incident highlights the regulatory authorities' emphasis on antitrust measures within the pharmaceutical industry, which could disrupt normal market operations [3] Combination Therapy Approvals - Pfizer announced that its oral targeted drug, Axi-cabtagene ciloleucel (Axitinib), has been approved for first-line treatment in combination with Toripalimab for high-risk, unresectable, or metastatic renal cell carcinoma (RCC) patients [4] - This approval marks the first and only approved first-line targeted and immune combination therapy for advanced kidney cancer in China, indicating a shift towards combination therapies in the treatment landscape [4]