9月20日，国家医保局公布了2025年国家基本医保目录与首版商业健康保险创新药目录（下称"商保目录"）的复评结果，标志着本年度"双目录"调整工作 进入关键阶段。此前8月12日，根据初步形式审查结果公示——有534个品种通过国家基本医保目录初审，121款药品入围商保创新药目录。 今年是国谈"双目录"的第一年，梳理商保目录的入围药品，能看到一个超预期的现象：121款申报商保目录的产品中，有79款同时通过了两个目录的初 审，"双报"比例超过六成： 从药企维度，这79款"双报"药来自74家药企，有4家药企"双报"了两种药品及以上，卫材是"双报"最多的一家药企，共申报了3款药； 从药品类别，79款"双报"药囊括了过往国谈的多个热门品类，包括19款罕见病药品、3款CAR-T疗法； 从价格层面，79款"双报"药中，有年治疗费用高达百万的明星药，也有日均费用仅有几元的常见病药品。 药企为何如此积极地在"双目录"国谈的首年选择"两条腿走路"？这79个"双报"药品背后，反映了行业怎样的心态与策略？ 与多家药企交流后发现，本质上"双报"反映了企业对药品在医保价格谈判环节的不确定心态。业内人士分析称，高价药往往选择"参与医保谈判，主 ...

Core Insights - The National Healthcare Security Administration (NHSA) has published the preliminary review results for the 2025 medical insurance and commercial insurance innovative drug directory, with significant changes in the approval status of six drugs compared to the previous version [1][2]. Summary by Categories Drug Approval Changes - Six drugs have had their approval status changed, with two drugs (Injectable Risperidone Microspheres and Injectable Triptorelin Acetate) being disapproved, while two others (Levodopa Injection and Calcium Gluconate Sodium Chloride Injection) have been approved [1][3]. - The oral suspension of Ursodeoxycholic Acid remains approved, but the conditions for approval have been adjusted [1][3]. Application Statistics - For the 2025 directory adjustment, the NHSA received 718 applications, involving 633 drug generic names, with 535 passing the preliminary review [1][2]. - The approval rate has increased significantly, reaching 84.52% this year, compared to 68.42% in 2023 and 76.66% in 2024 [2]. Notable Drugs - Levodopa Injection, used for Parkinson's disease, has been approved and is not an exclusive product, indicating its potential for broader market access [4]. - Injectable Ceftriaxone Sodium Sulbactam, another approved drug, is noted for its broad antibacterial spectrum and safety profile [4]. - The oral suspension of Ursodeoxycholic Acid has had its approval conditions modified to include rare disease categories [6]. Innovative Drug Directory - The commercial insurance innovative drug directory has been introduced alongside the basic medical insurance directory, with 141 applications received, of which 121 passed the preliminary review [2]. - A significant number of drugs in both directories are new, with 303 in the basic medical insurance directory meeting specific conditions for approval [7]. Rare Disease Drugs - The directories include a total of 37 rare disease drugs in the basic medical insurance directory and 35 in the commercial insurance innovative drug directory, with 19 drugs approved in both [10][11]. - Notable rare disease drugs include those from Merck and other companies, which have gained attention for their potential market impact [11][12]. Market Trends - The introduction of the commercial insurance innovative drug directory is expected to enhance market access for several high-profile drugs, including CAR-T therapies that have previously struggled to gain approval [9][12]. - The performance of rare disease drug companies has seen significant stock price increases, indicating strong market interest and potential for growth [13].

Core Viewpoint - The National Healthcare Security Administration (NHSA) has officially announced the preliminary review results for the adjustment of the 2025 medical insurance and commercial insurance innovative drug catalog, indicating an increase in the number of drugs passing the review and the overall approval rate compared to previous years [1][2]. Summary by Relevant Sections Drug Review Changes - Six drugs underwent changes in their review status, with two drugs, injectable risperidone microspheres and injectable triptorelin, being disapproved, while injectable levodopa and calcium gluconate sodium injection were approved [1][5][6]. - The injectable risperidone microspheres, an exclusive product of Shengzhao Pharmaceuticals, was first launched in mainland China in February 2025 for treating mental disorders [6][7]. - The injectable triptorelin, also an exclusive product, was launched in 2023 for treating prostate cancer and precocious puberty [7]. Approval Statistics - A total of 718 applications were received for the 2025 catalog adjustment, involving 633 drug generic names, with 535 passing the preliminary review, resulting in an approval rate of 84.52% [1][2]. - The approval rates have shown a significant increase over the past three years, with 68.42% in 2023, 76.66% in 2024, and 84.52% in 2025 [2]. Innovative Drug Catalog - The commercial insurance innovative drug catalog was introduced for the first time, with 141 applications received, involving 141 drug generic names, and 121 passing the review [3]. - Among the drugs, 79 were submitted for both the basic medical insurance catalog and the commercial insurance innovative drug catalog [3]. Notable Products - Several notable products are highlighted, including CAR-T products that have previously failed to enter the medical insurance catalog but are now included in the commercial insurance innovative drug catalog [11][12]. - Unique products such as the first and only AKT inhibitor and the only Trop-2 ADC for breast cancer treatment are also included in the catalogs, indicating a focus on innovative therapies [13][14]. Rare Disease Medications - The review process has also included rare disease medications, with 37 drugs in the basic medical insurance catalog and 35 in the commercial insurance innovative drug catalog, of which 19 are approved in both [15][16]. - The approval of rare disease drugs is seen as a significant development, with companies like Beihai Kangcheng gaining attention for their innovative products [20].

Group 1 - The core viewpoint of the article highlights the introduction of several high-value "star drugs" in the commercial health insurance innovative drug directory, which is expected to create new payment channels and benefit a broader patient population [1][2] - The National Healthcare Security Administration (NHSA) has initiated the adjustment of the commercial health insurance innovative drug directory, marking a significant step towards a multi-layered and balanced payment structure in the healthcare industry [1][2] - According to Frost & Sullivan, the share of commercial health insurance payments is projected to reach 16.3% by 2030, more than doubling from 2024, indicating a growing trend in the market [2] Group 2 - The construction of a diversified medical payment system faces challenges, including fragmented reimbursement rules and payment proportions across different payment methods, which complicates the payment process [2][3] - The "Yima Direct Payment" platform by Meixin Health exemplifies how platform companies are effectively addressing these challenges by integrating various payment solutions and streamlining complex claims processes [3] - The importance of ensuring that innovative drugs are accessible post-launch, including prescription transmission and direct payment capabilities, is emphasized as a critical factor for commercial insurance [2][3]

Core Viewpoint - The article discusses the recent adjustments to the national medical insurance drug catalog, highlighting the introduction of a commercial health insurance (commercial insurance) innovative drug catalog, marking the eighth adjustment since the establishment of the National Medical Insurance Administration. This new catalog aims to provide alternative payment pathways for high-priced innovative drugs, including CAR-T therapies, which have previously faced challenges in entering the basic medical insurance catalog [3][6][7]. Summary by Sections Medical Insurance Catalog Adjustments - A total of 534 drugs passed the preliminary review for the basic medical insurance catalog, while 121 drug generic names were approved for the commercial insurance innovative drug catalog [3][6]. - The introduction of the commercial insurance innovative drug catalog is seen as a significant development, providing a separate application channel for high-priced innovative drugs that exceed the basic insurance coverage [6][8]. Market Dynamics and Participation - Participation in the commercial insurance innovative drug catalog is voluntary for pharmaceutical companies and insurance firms, with the potential for significant market opportunities if successful [4][6]. - The commercial insurance catalog is expected to attract foreign companies, as early participation may yield policy benefits [8][9]. Financial Support for Innovation - The National Medical Insurance Administration has emphasized financial support for innovative drugs, with over 4.1 trillion yuan spent on negotiated drugs since 2018 [11]. - The new measures aim to enhance the efficiency of commercial insurance companies and support the development of innovative drugs through data services and one-stop compensation [11][12]. Challenges and Competition - The article notes the increasing competition and homogenization within the innovative drug market, with multiple similar drugs entering the market, leading to price competition [13][14]. - The National Medical Insurance Administration aims to support true innovation and differentiated innovation, focusing on drugs that provide additional clinical benefits and meet unmet medical needs [14].

Core Points - The adjustment of the medical insurance catalog this year marks the 8th since the establishment of the National Medical Insurance Administration and introduces a commercial health insurance (commercial insurance) innovative drug catalog for the first time [1][6] - A total of 534 drugs passed the formal review for the basic medical insurance catalog, while 121 drug generic names were approved for the commercial insurance innovative drug catalog, including high-priced innovative drugs like CAR-T [1][3] - The establishment of the commercial insurance innovative drug catalog indicates a significant shift in China's pharmaceutical industry, introducing a second major buyer beyond the basic medical insurance fund [3][6] Summary by Sections Medical Insurance Catalog Adjustment - The National Medical Insurance Administration announced the preliminary review results for the 2025 medical insurance drug catalog, with 534 drugs approved for the basic insurance catalog and 121 for the commercial insurance innovative drug catalog [1][3] - The commercial insurance innovative drug catalog provides a separate application channel for high-priced innovative drugs, which have historically faced challenges in entering the basic insurance catalog [3][4] Market Dynamics and Opportunities - Participation in the commercial insurance innovative drug catalog is voluntary for pharmaceutical companies and commercial insurance firms, presenting both risks and potential first-mover advantages [2][5] - The commercial insurance catalog aims to support high-priced innovative drugs that exceed the basic insurance scope, such as CAR-T therapies and rare disease medications [3][4] Policy Support and Industry Impact - The National Medical Insurance Administration has implemented measures to support the high-quality development of innovative drugs, with a focus on integrating commercial insurance and medical insurance to create a multi-tiered payment system for innovative drugs [6][7] - The introduction of the commercial insurance innovative drug catalog is expected to enhance the market potential for innovative drugs, providing a pathway for companies to transition from commercial insurance to basic insurance as market conditions evolve [5][7] Innovation and Competition - The pharmaceutical industry is experiencing increased competition and a trend of homogenization among innovative drugs, leading to price competition and the need for differentiation in innovation [8][9] - The National Medical Insurance Administration emphasizes the importance of supporting true innovation that offers additional clinical benefits and addressing unmet medical needs [9][10]

Core Points - The National Healthcare Security Administration (NHSA) has initiated the "dual directory" reform, establishing a new commercial insurance (commercial health insurance) innovative drug directory to support pharmaceutical innovation [1][6] - This year's adjustment marks the 8th time since the NHSA's establishment and is the first time a commercial insurance innovative drug directory has been added outside the basic medical insurance directory [1] - A total of 534 drugs passed the formal review for the basic medical insurance directory, while 121 drug generic names passed for the commercial insurance innovative drug directory, including high-priced innovative drugs like CAR-T [1][3] Group 1 - The establishment of the commercial insurance innovative drug directory provides a new independent application channel for high-priced innovative drugs [3][4] - The commercial insurance innovative drug directory targets drugs that exceed the basic medical insurance scope, are highly innovative, and meet significant clinical needs, such as high-priced cancer drugs and gene therapies [3][5] - The NHSA's support for innovative drugs includes financial backing through the inclusion of more innovative drugs in the insurance directory, as well as empowering the pharmaceutical industry and commercial insurance companies through data sharing and other reforms [6][7] Group 2 - The commercial insurance innovative drug directory is seen as a potential opportunity for pharmaceutical companies, allowing them to gain a first-mover advantage in a new market [2][5] - The NHSA has received 718 applications for the basic medical insurance directory, with a significant increase in the number of drugs passing the formal review compared to previous years [3][4] - The commercial insurance innovative drug directory is expected to alleviate some of the financial burdens on the basic medical insurance system, allowing for a more diversified payment system for innovative drugs [7][9] Group 3 - The innovative drug market in China is rapidly developing, with domestic companies exploring overseas business development and partnerships to expand their market reach [8] - There is a growing concern about the homogenization of innovative drugs, leading to increased price competition and the need for differentiation in drug offerings [9] - The NHSA emphasizes the importance of supporting true innovation and differentiated innovation in the pharmaceutical industry, ensuring that new drugs provide additional clinical benefits and meet unmet medical needs [9]