科创板公司共9款创新药首次纳入新版国家医保目录，另有多款代表性创新药实现成功续约或扩大适应 症，充分彰显了科创板创新药企的硬核实力与蓬勃生机。此外，科创板龙头药企百济神州有限公司(以 下简称"百济神州")的百赫安(通用名：注射用泽尼达妥单抗)、凯泽百(通用名：达妥昔单抗β注射液)2款 产品入选首版商保创新药目录，前沿产品获得了更广阔的支付路径，为产业高质量发展注入新动能。 前沿疗法加速惠及患者 在政策明确、路径清晰的有利环境下，科创板创新药公司的硬科技实力得以加速步入价值释放期，迎来 快速发展与成果收获。截至目前，科创板生物医药企业近九成已获批新药得到了医保支持。 科创板创新药公司上海君实生物医药科技股份有限公司(以下简称"君实生物")产品君适达(通用名：昂戈 瑞西单抗注射液)首次纳入医保目录，是新版国家医保目录中唯一用于他汀不耐受人群的国产PCSK9靶 点药物。 科创板创新药公司海创药业股份有限公司(以下简称"海创药业")自主研发的首款上市药物海纳安(通用 名：氘恩扎鲁胺软胶囊)于2025年5月底获批上市，用于治疗转移性去势抵抗性前列腺癌。海创药业表 示，该药物被纳入2025年医保目录将有利于后续市场推广， ...

Core Viewpoint - The release of the commercial health insurance innovative drug directory addresses the issue of "can it be used" at the hospital level, but the "last mile" between high-priced innovative drugs and patients remains unconnected. To achieve seamless transformation from "policy text" to "patient benefit," three key barriers must be crossed [1][3]. Group 1: Release of the Directory - On December 7, 2025, the National Healthcare Security Administration officially released the first version of the "Commercial Health Insurance Innovative Drug Directory," incorporating 19 high-clinical-value, high-cost innovative drugs into the commercial health insurance payment framework for the first time at the national level [2]. - The directory includes 14 anti-tumor drugs (including all 5 CAR-T therapies available in China), 2 rare disease drugs, and 2 Alzheimer's disease new drugs, aligning with the current claims data of commercial health insurance, where malignant tumors are the most prevalent and costly disease area [2]. Group 2: Policy Support and Challenges - The commercial health insurance innovative drug directory is supported by policies that exempt the listed drugs from self-payment rate assessments, collection of alternative monitored varieties, and DRG payment scope, addressing the challenges hospitals face in using innovative drugs under cost control pressures [3]. - Despite the directory solving the "can it be used" issue, the connection between high-priced innovative drugs and patients still needs to be established, requiring standardization and universalization of the directory [3][4]. Group 3: Standardization and Payment Collaboration - The current directory serves as a guiding list rather than a mandatory coverage requirement for commercial insurance products, necessitating the promotion of core drugs in the directory as standard configurations in commercial health insurance, especially in inclusive "benefit insurance" products [4]. - The basic medical insurance market can leverage its large insured population to negotiate lower drug prices, but the fragmented nature of the commercial health insurance market poses challenges in forming a cohesive payment force to negotiate with pharmaceutical companies [4]. Group 4: Service Integration and Patient Experience - An ideal multi-tiered payment system should achieve seamless integration and instant settlement among basic medical insurance, commercial insurance, and patient out-of-pocket expenses, which currently requires patients to prepay and navigate complex claims processes [5]. - Commercial insurance accounts for only 7.7% of the overall payment for innovative drugs, indicating significant growth potential. Bridging the "last mile" between the 19 innovative drugs in the directory and patients requires coordinated efforts from government and market forces [5].

Core Insights - The National Healthcare Security Administration (NHSA) has officially released the first version of the "Commercial Health Insurance Innovative Drug Directory," incorporating 19 high-value, expensive innovative drugs into the commercial health insurance payment framework for the first time [1][2] - The introduction of this directory marks a significant step in improving China's multi-tiered medical security system and transforming the role of commercial insurance [1] Group 1: Directory Overview - The directory includes 19 drugs, of which 14 are anti-tumor drugs (including all 5 CAR-T therapies available in China), 2 are rare disease medications, and 2 are new drugs for Alzheimer's disease [1] - The structure of the directory aligns closely with current claims data from commercial health insurance, as malignant tumors are the most prevalent and costly disease area in China [1] Group 2: Policy Support - The drugs listed in the commercial health insurance innovative drug directory are exempt from self-payment rate assessments, do not fall under centralized procurement monitoring, and are not included in the Diagnosis-Related Group (DRG) payment scope, referred to as the "three exclusions" policy [2] - This policy alleviates the challenges hospitals face in using innovative drugs amid pressures from centralized procurement and DRG payment reforms [2] Group 3: Implementation Challenges - The transition from policy text to patient benefits requires overcoming three key barriers: standardization and inclusivity of the directory, payment coordination and bargaining power, and service fluidity and one-stop experience [2][3][4] - The current directory serves as a guiding list rather than a mandatory coverage requirement for commercial insurance products, necessitating efforts to make core drugs standard features in commercial health insurance, especially in inclusive "benefit insurance" products [3] Group 4: Payment and Service Integration - The commercial health insurance market is fragmented, with varying funding levels and coverage across different regions, which raises uncertainties about its ability to negotiate effectively with pharmaceutical companies [3] - Establishing a regional or national commercial insurance procurement coordination mechanism is essential for negotiating better drug prices and conditions, ensuring financial sustainability of coverage plans [3][4] - The ideal multi-tiered payment system should enable seamless integration and immediate settlement among basic medical insurance, commercial insurance, and out-of-pocket expenses, which currently requires patients to prepay and navigate complex claims processes [4]

Core Insights - The newly released commercial insurance innovative drug directory includes 19 drugs, with 6 specifically for rare diseases, addressing conditions such as neuroblastoma and Gaucher disease [1][3] - The directory aims to provide a reference for multi-tiered medical insurance systems, but attracting more commercial insurance participation remains a challenge [1][6] Summary by Sections Rare Disease Drug Inclusion - The innovative drug for short bowel syndrome, injection of teduglutide, is set to be the first GLP-2 analog approved in China, filling a long-standing gap in treatment options [3][4] - Gaucher disease, affecting approximately 3,000 patients in China, now has a locally developed enzyme replacement therapy, injection of velaglucerase alfa, included in the directory [5] Challenges in Commercial Insurance - The increasing pressure on basic medical insurance funds makes it unrealistic to rely solely on them for rare disease drug coverage, highlighting the need for commercial insurance products like Huiminbao [6][8] - Huiminbao has made strides in covering certain rare disease drugs, but the number of drugs and policies available for rare diseases still needs improvement [8] Future Directions - Experts suggest that a multi-tiered approach involving basic insurance, commercial insurance, and charitable support is essential for effective rare disease drug coverage [9][10] - The focus should shift from post-reimbursement to comprehensive service and long-term health management for rare disease patients [10]

黄心宇表示，之所以前述PD-1类药品没有纳入商保创新药目录，是因为它们和基本医保目录内的药品 有很强的替代性。 "目前基本医保目录内已有10款左右PD-1" "今年，一些PD-1类药品也申报了商保创新药目录，但最终都没有成功入选。"国家医保局医药服务管理 司司长黄心宇12月9日表示。 12月9日晚间，国家医保局在线播出2025年医保药品目录解读会。黄心宇在会上说，今年国家医保局共 收到了141个商保创新药目录的申报信息，涉及药品通用名141个，说明参与申报的药品都是独家产品， 最终有121种药品通过了形式审查。这121种目录外药品在进入专家评审阶段后，仅24种药品通过评审， 通过率不到20％。之后，在价格协商阶段，24种药品中有19种价格协商成功，最终被纳入商保创新药目 录。 "目前基本医保目录内已有10款左右PD-1了。"黄心宇透露。 他进一步表示，从今年基本医保目录中新增药品的治疗领域来分析，肿瘤药还是大头，共计新增纳入36 种肿瘤治疗药物。包括肿瘤药在内，这些基本医保目录内新增药品有三个共性特征：填补临床空白、同 类更优和更具性价比。 "今年也有好几款PD-1通过了（基本医保目录谈判）的专家评审，但也有 ...

Core Insights - The National Healthcare Security Administration and the Ministry of Human Resources and Social Security have released the new National Medical Insurance Directory and the first Commercial Health Insurance Innovative Drug Directory, set to be implemented nationwide from January 1, 2026 [1][2] Summary by Sections National Medical Insurance Directory - A total of 114 new drugs have been added to the National Medical Insurance Directory, with 111 of them being new products launched within the last five years, representing 97.3% of the new additions [2] - Among the new drugs, 50 are classified as Category 1 innovative drugs, with a 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] Company Announcements - Several listed companies, including Heng Rui Medicine, Fosun Pharma, and Hai Si Ke, announced new drug inclusions or renewals in the updated National Medical Insurance Directory [3] - Heng Rui Medicine reported that 20 products/indications were included, with significant coverage across various diseases such as tumors and cardiovascular conditions [3][4] - Hai Si Ke's two Category 1 innovative drugs were included, with one being a new addition and the other a renewal [4] 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 Category 1 innovative drugs [7] - Notably, five CAR-T products were included, representing over half of the CAR-T products available in China, which previously faced challenges in entering the insurance market due to high pricing [7][8] - The directory also includes treatments for rare diseases and high-profile conditions such as Alzheimer's disease, enhancing the complementarity with the basic medical insurance [7][10] Notable Drug Inclusions - The directory includes drugs for significant diseases such as triple-negative breast cancer and pancreatic cancer, as well as treatments for rare diseases like Gaucher disease [5][9] - In the diabetes sector, several domestic drugs were newly included, such as a long-acting GLP-1 receptor agonist [6] - Companies like Bei Hai Kang Cheng and Bai Ji Shen Zhou have also successfully included their innovative drugs in the Commercial Health Insurance Directory [9]

央视网消息：12月7日国家医保局公布了医保目录，跟之前七年公布的目录相比，这一次增加了商保的创新药的目录，这次涉及到的是19种药品，包括治疗 肿瘤、罕见病，还有阿尔茨海默的药品，它们共同的特点是创新程度高、临床价值大、患者获益显著，并且超出基本医保保障范围。值得一提的是，这19种 药品是并非强制性的名录。这个目录对于患者、用药人、医院、医保、商业保险来说，都会带来什么样的影响？另外基本保险和商保之间应当如何协同，才 能够更好的发挥效用？ 首个商保创新药目录，为何现在推出？ 上海财经大学金融学院保险系教授 粟芳：整个保险行业对于这个创新药的目录已经期盼很久了，消费者也希望保险行业能有一个标准的目录出现，这次集 合了保险公司、国家相关部门、药企的共同努力，才在第8次出台了这份目录。这份目录的出台，对各方来说都是一个利好。对于消费者来，将来购买保险 就有据可查，在过去没有这个目录的时候，可能各保险公司的赔付标准完全不同，消费者就会不知道哪家保险公司的产品会更好，以及该买哪家保险公司的 产品。有了这个标准之后，各家公司的在设计保险产品的时候，也可以根据这个标准来执行。其次国家的这个目录其实具有大规模采购的效应，所以药 ...

Core Data - A total of 18 companies and 19 drugs have been included, comprising 9 types of first-class innovative drugs [1] Key Content - Focus on cutting-edge and special demand drugs such as CAR-T, Alzheimer's disease, and pediatric rare diseases; the strategy aims to create a "bottom-line + supplementary" insurance guarantee framework that complements basic medical insurance [2]

经济观察网 据"礼来Lilly"微信公众号消息，12月7日，中国国家医疗保障局公布了新版基本医保药品目 录及首版商保创新药目录，同期国家医保药品目录调整发布大会在广州举行。礼来阿尔茨海默病疾病 (AD)修饰疗法记能达 （多奈单抗注射液）进入首版商保创新药目录。记能达 纳入商保创新药目录填补 了此前传统治疗三大空白，无靶向Aβ斑块药物、无AD疾病修饰治疗、无针对AD源性轻度认知障碍药 物。 ...

Core Viewpoint - The inclusion of CAN 103 in China's first version of the "Commercial Insurance Innovative Drug Directory" marks a significant milestone for the company, ensuring broader access to effective domestic enzyme replacement therapy for Gaucher disease patients [1][2]. Group 1: Product Development and Approval - CAN 103 is the first domestically developed enzyme replacement therapy for Gaucher disease in China, approved for use in adolescents aged 12 and above and adults with Type I and III Gaucher disease [1]. - The drug was approved for market launch on May 13, 2025, and officially entered clinical application on July 2, 2025, at Xinhua Hospital affiliated with Shanghai Jiao Tong University School of Medicine [1]. Group 2: Regulatory and Market Context - The "Commercial Insurance Innovative Drug Directory" is set to be implemented on January 1, 2026, and includes innovative drugs that exceed basic insurance coverage and have significant clinical value [1]. - In the 2025 medical insurance negotiations, 121 drug varieties applied for inclusion in the directory, but only 24 were selected for negotiation [1]. Group 3: Impact on Patients and Healthcare - The inclusion of CAN 103 in the directory will ensure that Gaucher disease patients have access to safe and effective domestic enzyme replacement therapy, providing broader and more comprehensive treatment coverage [2].