近日，首版商保创新药目录通过初审名单正式公布，121款药品赫然在列，"双目录"时代亦近在咫尺。 《科创板日报》记者注意到，复星医药旗下有多款产品进入首版商保创新药目录初审名单，其中备受关 注的120万元/针 CAR-T 疗法阿基仑赛注射液亦在列。值得一提的是，该产品自2021年在国内上市以 来，已连续四年通过国家医保药品目录的初步形式审查，但最终因国谈中"50万不谈，30万不进"的隐形 门槛均未通过专家评审，无缘医保谈判桌。 此次阿基仑赛注射液仅申报了商保创新药目录，而与该产品一同进入初审名单的，还有另外四款CAR-T 疗法，该五款CAR-T疗法在后续专家评审、价格协商等环节将有如何表现，最终能否顺利纳入商保目 录，并实现市场价值与患者可及性的平衡，成为行业的关注点之一。 启德医药董事长秦刚则对《科创板日报》记者指出："中国商业保险体系纳入创新药，是我们创新药从 业者期盼多年的事。不过同时也存在大量不确定性，如何推动相关政策落地，仍需行业持续观望与深入 思考。" 对于一众创新药企而言，国家医保局首次将商业健康险纳入目录体系，这一举措不仅打破了此前支付端 的单一格局，更通过"基本医保保基本、商业健康险保创新"的 ...

《科创板日报》8月24日讯（特约记者 史追云）2025 年正在成为创新药迈入支付新纪元的关键节点。 近日，首版商保创新药目录通过初审名单正式公布，121款药品赫然在列，"双目录"时代亦近在咫尺。 对于一众创新药企而言，国家医保局首次将商业健康险纳入目录体系，这一举措不仅打破了此前支付端 的单一格局，更通过"基本医保保基本、商业健康险保创新"的协同模式，为创新药在临床应用中突破支 付瓶颈提供了新路径——既能缓解高价创新药的患者支付压力，让更多突破性疗法触达需求群体，也为 药企在定价策略与市场覆盖间找到了更灵活的支点。 启德医药董事长秦刚则对《科创板日报》记者指出："中国商业保险体系纳入创新药，是我们创新药从 业者期盼多年的事。不过同时也存在大量不确定性，如何推动相关政策落地，仍需行业持续观望与深入 思考。" 上述提到的不确定性是多方面的，一方面，商保在公平性考量、参照药选择、价格协商底价形成等核心 操作环节仍缺乏成熟经验。与此同时，当前商保创新药目录仅具备指导性意义，地方层面在落地执行时 的推进力度、实施细则差异等，还有一个观察窗口期。 另一方面，量价关联机制尚未清晰界定，商业保险的支付规模与药品实际销量之间未 ...

Core Viewpoint - The National Healthcare Security Administration (NHSA) has introduced a dual-track system for drug listings, which includes a new commercial health insurance innovative drug directory, highlighting the critical role of commercial health insurance in the medical security system [1][2]. Group 1: Drug Directory Dual-Track System - The new dual-track system allows for basic medical insurance to focus on essential coverage while the commercial health insurance innovative drug directory provides supplementary coverage for high-priced drugs that do not qualify for the basic insurance directory [2]. - A total of 534 drugs were approved for the basic medical insurance directory, while 121 drugs made it to the commercial health insurance innovative drug directory, with a significant majority being Western medicines [2][3]. - Approximately 80 drugs applied for both directories, accounting for about 60% of the commercial health insurance innovative drug directory, indicating a strategic approach to drug approval [2]. Group 2: Role of Commercial Health Insurance - Commercial health insurance is positioned as a "second payment layer" to address the challenges of high-cost innovative drugs and to enhance the multi-tiered medical security system [4][5]. - The increasing demand for innovative drugs due to aging populations and rising medical costs necessitates the involvement of commercial health insurance to cover expenses beyond the basic insurance scope [4][5]. - Local governments are actively promoting commercial health insurance to support the development of innovative drugs, with measures to encourage the integration of innovative drug costs into group health insurance products [6]. Group 3: Challenges and Opportunities - Despite the potential of commercial health insurance, its current contribution to innovative drug payments remains low, with only 7.7% of the market share, indicating a heavy financial burden on patients [7]. - To enhance the payment capacity of commercial health insurance, collaboration among insurance companies, pharmaceutical firms, and healthcare providers is essential, focusing on innovative service models [7]. - The NHSA has introduced supportive policies for the commercial health insurance innovative drug directory, which may help expand coverage and optimize services for high-cost drugs [7][8].

Core Viewpoint - The National Healthcare Security Administration (NHSA) has announced the preliminary review results for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, with 534 drugs passing the initial review for basic insurance and 121 innovative drugs for commercial health insurance [1][2] Summary by Sections Commercial Health Insurance Innovative Drug Directory - The commercial health insurance innovative drug directory is voluntary for pharmaceutical companies and insurance firms, meaning that the success of negotiations remains uncertain [3][4] - The directory aims to include innovative drugs that exceed the basic insurance coverage, focusing on high clinical value and significant patient benefits [5][6] Market Dynamics and Drug Coverage - The directory primarily covers unmet needs in areas such as oncology, rare diseases, and chronic conditions, with several CAR-T therapies included [6][7] - The inclusion of domestic pharmaceutical products has increased, enhancing the controllability of the drug supply chain [6][7] Challenges in Implementation - The process from preliminary review to final inclusion in the directory involves multiple steps, including expert evaluation and price negotiations, which introduces uncertainty [9][11] - Concerns exist regarding the balance between patient accessibility and the sustainability of insurance companies, particularly regarding the definition of coverage limits and risk management [10][11] Impact on Insurance Products - The innovative drug directory is expected to stimulate discussions on product innovation within the insurance industry, encouraging companies to optimize their product strategies based on the directory [13][14] - Insurance companies are advised to design products that cater to different consumer capabilities, enhancing the appeal of high-end medical insurance [14][15] Future Market Potential - The innovative drug market in China is projected to reach 1 trillion yuan by 2035, with commercial health insurance expected to cover a significant portion of this market [16][17] - The NHSA's recent measures aim to establish a multi-layered payment system for innovative drugs, enhancing their accessibility and reducing the financial burden on patients [17][18]

Core Insights - The National Healthcare Security Administration (NHSA) has announced the preliminary review results for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, with 534 drugs passing the initial review for basic insurance and 121 innovative drugs for commercial health insurance [1][3] - The commercial health insurance innovative drug catalog aims to include high-value innovative drugs that are not covered by basic insurance, focusing on areas such as oncology and rare diseases [4][15] - The process for drugs to be included in the commercial health insurance catalog involves multiple steps, including expert review and price negotiations, which introduces uncertainty regarding the final inclusion of these drugs [7][10] Industry Dynamics - The NHSA's new policies are seen as a significant step towards creating a multi-layered payment system for innovative drugs, addressing the historical challenges of insufficient insurance coverage and high out-of-pocket costs for patients [15][16] - The commercial health insurance sector is expected to play a crucial role in expanding access to innovative drugs, with the potential to cover a larger patient base and enhance the financial viability of drug companies [17] - The introduction of the commercial health insurance innovative drug catalog is anticipated to stimulate product innovation within the insurance industry, as companies adapt their offerings to meet the needs of patients seeking coverage for high-cost medications [11][12] Market Opportunities - The innovative drug market in China is projected to reach 1 trillion yuan by 2035, with commercial health insurance expected to cover 44% of this market, translating to approximately 440 billion yuan [14][15] - The inclusion of domestic drug companies in the innovative drug catalog is increasing, which may enhance the stability of the drug supply chain and improve pricing negotiations [4][16] - The potential for specialized insurance products targeting high-net-worth individuals seeking coverage for innovative drugs is growing, as insurers look to differentiate their offerings in a competitive market [12][13]

Core Insights - The National Healthcare Security Administration (NHSA) has released the initial review list for the "Commercial Insurance Innovative Drug Directory," marking a significant step in integrating commercial insurance with the national medical insurance system [2][3] - The list includes various high-value innovative drugs, such as CAR-T therapies and rare disease medications, which are expected to enhance market confidence and improve patient outcomes [2][6] Group 1: Commercial Insurance Directory - A total of 141 applications were received for the commercial insurance innovative drug directory, with 121 drug names passing the initial review [3] - The directory features expensive high-value innovative drugs, including CAR-T therapies, which have an average price in the million yuan range [3][4] - Some CAR-T products are being submitted for both basic medical insurance and commercial insurance, providing a second chance for reimbursement if they fail in the first round [4][5] Group 2: Rare Disease Medications - The commercial insurance directory includes 51 products for 52 rare diseases, potentially allowing patients to access previously unaffordable "orphan drugs" through commercial insurance [6] - The example of nusinersen for spinal muscular atrophy (SMA) illustrates the significant cost reduction from nearly 700,000 yuan to approximately 33,000 yuan after entering the insurance system [6] - The number of rare disease drugs in China is expected to increase, with 210 drug development pipelines projected for 2024, 38% of which are in Phase III clinical trials [6][7] Group 3: Market Dynamics and Future Outlook - The integration of commercial insurance with the national medical insurance system is seen as a flexible approach to facilitate access to high-value innovative drugs [7] - The expected results from national negotiations on drug pricing will be announced between October and November 2025, while the commercial insurance directory is set to be finalized by the end of September [7] - The evolving landscape indicates a narrowing gap between the availability and affordability of innovative treatments for patients [7]

Core Insights - The National Healthcare Security Administration (NHSA) announced the preliminary review results for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, revealing 534 drugs passed the review, with 121 drugs included in the commercial insurance innovative drug catalog [1][2] - This year marks the first implementation of a "dual-track system" for the drug catalog, focusing on basic insurance for essential drugs and providing supplementary coverage for "exclusive new drugs" or "rare disease medications" through commercial insurance [1][2] - The number of drugs passing the preliminary review has significantly increased compared to last year, with the number of drug names outside the catalog rising from 249 in 2024 to 310 [1] Drug Categories and Highlights - Over 98% of the drugs in the announced list are Western medicines, with only two traditional Chinese medicines included [3] - CAR-T therapies, which are at the forefront of cancer treatment, have gained attention, with several priced over 1 million yuan per injection, including products from Fosun Kite, Kintor Pharmaceutical, and Reindeer Biologics [1][2] - Notable entries in the list include innovative drugs from domestic companies, such as Shanghai Xinnian Pharmaceutical's hemophilia B gene therapy and Hengrui Medicine's PD-1 monoclonal antibody [3] Review and Approval Process - Passing the preliminary review does not guarantee inclusion in the basic medical insurance or commercial insurance innovative drug catalog, as further expert evaluations and price negotiations are required [3] - Approximately 80 drug varieties passed the preliminary review for both the basic medical insurance and commercial insurance catalogs, indicating potential for simultaneous negotiations [3]

Core Insights - The article discusses the announcement by the National Medical Insurance Administration regarding the preliminary review of 534 drugs for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, along with 121 drugs included in the commercial insurance innovative drug catalog [1][2]. Group 1: Drug Catalog Adjustments - The 2025 drug catalog adjustments implement a "dual-track system," focusing on basic insurance for essential drugs while providing supplementary coverage for "exclusive new drugs" or "rare disease medications" through the commercial insurance innovative drug catalog [1][2]. - A total of 718 applications were received for the basic medical insurance catalog, with 534 approved, while 141 applications were received for the commercial insurance innovative drug catalog, with 121 approved [1][2]. Group 2: CAR-T Therapies - CAR-T therapies, which are personalized cancer treatments, have gained attention due to their high costs, with prices exceeding 1 million yuan per injection for several products [1][2]. - The article highlights that CAR-T therapies are among the first specialty drugs to be included in commercial insurance coverage, with various regions like Jiangsu and Shanghai incorporating them into their insurance plans [2]. Group 3: Drug Composition and Approval Process - The approved drugs are predominantly Western medicines, with over 98% of the list, and only two traditional Chinese medicines included [3]. - The approval of drugs through preliminary review does not guarantee inclusion in the basic medical insurance or commercial insurance catalogs, as further expert evaluations and price negotiations are required [3]. Group 4: Pricing and Negotiation - Approximately 80 drug varieties passed the preliminary review for both the basic medical insurance and commercial insurance catalogs, indicating potential for simultaneous negotiations [3]. - Drugs that exceed the basic insurance pricing limits may still qualify for the next evaluation stage, but their final inclusion depends on successful negotiations [3].

Core Insights - The National Healthcare Security Administration (NHSA) announced the preliminary review results for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, revealing 534 drugs passed the review, with 121 drugs included in the commercial insurance innovative drug catalog [1][2] Group 1: Drug Catalog Adjustments - The 2025 adjustments mark the first implementation of a "dual-track system," focusing on basic insurance for essential drugs while providing supplementary coverage for "exclusive new drugs" or "rare disease medications" through the commercial insurance innovative drug catalog [1][2] - A total of 718 submissions were received for the basic insurance catalog, with 534 approved, while 141 submissions were made for the commercial insurance catalog, with 121 approved [1][2] - The number of drug names excluded from the catalog increased from 249 in 2024 to 310 [1] Group 2: CAR-T Therapies - CAR-T therapies, which are personalized cancer treatments, have gained attention due to their high costs, with prices exceeding 1 million yuan per injection for several products [1][2] - The commercial insurance catalog will include CAR-T therapies in upgraded coverage plans in various regions, with Shanghai's "Huibao" covering up to 500,000 yuan for patients [2] - Over the past three years, more than 80 lymphoma patients have received treatment through this channel, with total reimbursements exceeding 40 million yuan [2] Group 3: Drug Composition and Approval Process - The approved drugs are predominantly Western medicines, with over 98% representation, and only two traditional Chinese medicines included [3] - Notable cancer drugs include those from major pharmaceutical companies, alongside innovative domestic products like gene therapy for hemophilia B and PD-1 monoclonal antibodies [3] - Passing the preliminary review does not guarantee inclusion in the final catalog, as further expert evaluations and price negotiations are required [3][4] Group 4: Submission Conditions - Unique drugs meeting specific criteria can apply for both the commercial insurance innovative drug catalog and the basic catalog simultaneously [4]

Core Insights - The strategic partnership between Koyi Pharmaceutical and ERIGEN LLC focuses on the exclusive overseas licensing of Koyi's CAR-T product KQ-2003, covering global rights outside of India, Turkey, and Russia [1] - Koyi Pharmaceutical will receive an upfront payment of $15 million and is eligible for milestone payments up to $1.32 billion, along with potential sales royalties of up to $800 million based on net sales in the licensed regions [1] Product Development - KQ-2003 is currently in Phase 1/2 clinical trials for multiple myeloma and POEMS syndrome, with promising efficacy reported in ongoing trials [2] - The product has shown a total response rate (ORR) of 100% in a study involving 23 patients, with 88.9% achieving stringent complete response (sCR) [3] Market Context - The CAR-T market in China has six approved products, with Koyi's approach to international collaboration reflecting a broader trend among domestic manufacturers seeking to expand globally [4] - High production costs remain a significant barrier to the widespread adoption of CAR-T therapies, prompting companies to explore international markets [5]