每经记者｜林姿辰 每经编辑｜陈柯名 陈俊杰 8月13日开盘，北海康成股价大涨，截至收盘涨25.75%。 8月13日，百洋医药方面对《每日经济新闻》记者表示，公司非常看好罕见病赛道，公司将与北海康成一起拓展并丰富罕见病药物管线，同时提升罕见病 药物可及性，惠及更多患者。记者注意到，今年以来，北海康成这个"罕见病第一股"股价涨幅已经超过1400%。 作为创新药中最难商业化的品类之一，罕见病用药面临的进院难"坚冰"是否正在融化？ 公司获得1亿元战略投资 百洋医药首次涉足罕见病投资 今日早间，公司宣布了战略融资事项以及与百洋医药的独家商业服务协议，后者的附属公司将作为独家合同销售组织（CSO），在内地、香港及澳门推广 北海康成的若干产品。前一日，公司两款产品一齐出现在国家医保局公示的商保创新药目录初审名单中。 8月13日，北海康成宣布与百洋医药达成股份认购协议，将以每股1.34港元的价格向其发行股份，总发行价款达1亿港元，该等认购股份将约占公司现有已 发行股本的17.65%，及经扩大后股本的14.99%。 就此，公司获得一笔1亿港元的战略投资，而投资方百洋医药是国内头部创新品牌商业化平台，在OTC（非处方药）及大健康 ...

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].

Group 1 - The adjustment of the national medical insurance drug catalog for 2025 has been initiated, including the establishment of a commercial health insurance innovative drug catalog for the first time by the National Healthcare Security Administration [1] - The preliminary review of the first version of the commercial health insurance innovative drug catalog has been published, with 141 drug applications received, and 121 drug names passing the initial review [2] - The basic medical insurance system covers 1.326 billion people in 2024, maintaining a coverage rate of 95%, with total fund expenditure reaching 2.97 trillion yuan [3] Group 2 - The overall funding level of basic medical insurance is low, with an average funding of 1,070 yuan per person, of which about two-thirds comes from various levels of fiscal subsidies [5] - In 2024, the original insurance premium income of commercial health insurance in China reached 977.3 billion yuan, a year-on-year increase of 8.2%, approaching the total funding level of residents' medical insurance [7] - The establishment of the commercial health insurance innovative drug catalog is expected to enhance the integration of basic medical insurance and commercial health insurance funds, providing better economic support for innovative drug development [9]

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]

Group 1 - The Hong Kong stock market showed positive performance on August 13, with the innovative drug sector experiencing fluctuations but maintaining investor interest [1] - According to Wind data, as of August 12, the pharmaceutical and biotechnology sector was the top recipient of southbound capital net purchases over the past week, indicating strong market focus on innovative drugs [1] - The Hang Seng Pharmaceutical ETF (159892) rose nearly 1.5%, while the Hong Kong Stock Connect Medical ETF (520510) increased by approximately 2.5% [1] Group 2 - The National Healthcare Security Administration announced the preliminary review results for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, with 121 drug generic names passing the initial review for the commercial insurance innovative drug catalog [1] - The inclusion of innovative drugs in the commercial insurance category signifies an enhanced role of commercial insurance in the multi-tiered medical security system [1] - Guoyuan Securities believes that the expansion of the commercial insurance innovative drug catalog will create more development opportunities for the innovative drug industry [1]

Core Points - The National Healthcare Security Administration (NHSA) has published the preliminary results of the review for the 2025 National Basic Medical Insurance (BMI) and commercial insurance innovative drug directories, with 534 drug names approved for the BMI directory and 121 for the commercial insurance directory [1][2] - The review process includes initial review, public announcement of results, re-evaluation, and final announcement, with the initial review being the first step in the overall directory adjustment process [1][2] Summary by Sections Initial Review Results - A total of 718 submissions were received for the BMI directory, involving 633 drug names, with 534 passing the initial review [2] - The number of drugs passing the initial review from outside the directory increased significantly from 249 in 2024 to 310 in 2025 [2] - The approved drugs cover various fields, including oncology, chronic diseases, and rare diseases, with notable CAR-T products and antibody-drug conjugates (ADCs) included [2][3] Pricing and Evaluation - Some high-priced drugs, such as CAR-T therapies and enzyme replacement therapies, have passed the initial review but may not meet the BMI's implicit pricing thresholds [3] - The NHSA emphasizes that passing the initial review does not guarantee inclusion in the BMI directory, as further evaluations and negotiations are required [3][4] Payment Mechanisms and Sustainability - The need for differentiated payment mechanisms to support innovative drugs while ensuring sustainable development is highlighted [4][5] - The introduction of the commercial insurance innovative drug directory aims to enhance service attributes and drive transformation in the commercial insurance sector [5][6] Dual Directory System - The commercial insurance directory received 141 submissions, with 121 drug names passing the initial review, indicating a strong focus on innovative and high-value drugs [5][6] - The dual directory system is expected to foster innovation in drug development and improve patient access to treatments [7]

Group 1 - The National Healthcare Security Administration (NHSA) announced that 534 drug generic names passed the preliminary formal review for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog, a significant increase compared to the previous year [1][2] - A total of 718 submissions were received for the basic medical insurance catalog, with 633 drug generic names involved, and 534 passed the preliminary review, indicating a notable rise from 249 in 2024 [1][2] - The introduction of a commercial insurance innovative drug catalog alongside the basic medical insurance catalog reflects an enhancement of the role of commercial insurance in the multi-tiered medical security system [3] Group 2 - The formal review process is designed to ensure that submitted drugs meet the necessary conditions and that the information provided is complete and accurate, which is crucial for subsequent evaluation and assessment stages [2] - The NHSA emphasized that passing the preliminary formal review only indicates eligibility for further processes and does not guarantee inclusion in the drug catalog [2][3] - Feedback received during the public notice period will be used to verify the information of the drugs and finalize the list of those that passed the formal review [3]

7月1日，国家医保局联合国家卫生健康委出台的《支持创新药高质量发展的若干措施》（以下简称 《若干措施》）发布。其中提出的"增设商业健康保险创新药品目录"备受关注。 在当日国家医保局举行的新闻发布会上，国家医保局医药管理司司长黄心宇表示："基本医保和商 业健康保险都是我国多层次医疗保障体系的重要组成部分。《若干措施》提出了加强对创新药研发支 持，支持创新药进入医保药品目录和商保创新药目录，鼓励创新药临床应用，提高创新药多元支付能 力，以及强化组织保障等5方面16条具体举措。未来一段时间，将为支持我国创新药的高质量发展提供 积极助力。" 《若干措施》提出，适应多层次医疗保障体系发展需要，增设商业健康保险创新药品目录，重点纳 入创新程度高、临床价值大、患者获益显著且超出基本医保保障范围的创新药，推荐商业健康保险和医 疗互助等多层次医疗保障体系参考使用。 商保重要性日益凸显 数据显示，我国基本医保体系已覆盖超过13亿人，参保率稳定在95%。2024年，医保基金支出达 2.97万亿元，为医疗体系运行和医药产业发展提供了坚实保障。自2018年以来，149种创新药（主要为1 类创新药）纳入医保目录，占新增药品数量的17%。 ...

Core Insights - The article discusses the challenges and opportunities faced by innovative drug companies in China, particularly in relation to pricing strategies and market access for CAR-T therapies [1][2][3] Pricing Strategies - Innovative drug companies are experiencing a significant pricing gap between domestic and international markets, with some drugs priced 20 to 30 times higher abroad compared to China [1][2] - The introduction of a dual directory system for insurance coverage, including a commercial insurance directory for innovative drugs, aims to enhance pricing confidentiality and improve patient access [9][11] Market Dynamics - There is a trend of local innovative drug companies shifting their focus to overseas markets, which may impact their competitiveness in China and the benefits to domestic patients [2][7] - The average time for innovative drugs to be included in the national insurance directory has decreased from around 5 years to approximately 1 year, with 80% of new drugs entering the directory within two years of launch [6][8] Regulatory Environment - The National Healthcare Security Administration (NHSA) has been implementing a price confidentiality mechanism since 2019, with the proportion of companies requesting non-disclosure of negotiation prices rising from under 50% in 2019 to over 70% in 2022 [3][4] - Despite the introduction of price confidentiality, there are concerns about the effectiveness of these measures in practice, particularly during the distribution and procurement phases [4][5] Future Outlook - The article highlights the need for improved regulatory frameworks to support innovative drug pricing strategies, especially as China becomes a more prominent market for new drug launches [7][10] - The potential for innovative payment models, such as risk-sharing agreements, is discussed as a way to enhance the sustainability of innovative drug pricing while maintaining confidentiality [10][11]

Core Insights - The establishment of a national "medical insurance + commercial insurance" clearing and settlement center in Beijing aims to enhance the efficiency of patient reimbursement and reduce the financial burden of medical expenses [1][4] - The acceleration of data sharing between medical insurance and commercial insurance is supported by recent government policies, which emphasize improving the quality of health insurance services and facilitating quick medical expense settlements [2][3] Group 1: Policy Support and Development - Multiple policies since last year have promoted the integration of medical insurance and commercial insurance, with a focus on enhancing service levels and expanding coverage [2] - The National Medical Insurance Administration has outlined key tasks for 2025, with several initiatives aimed at improving data sharing and collaboration between commercial health insurance and basic medical insurance [3][6] Group 2: Operational Changes and Patient Experience - The new clearing center offers two options for patients: "fast compensation" and "direct compensation," significantly reducing the time required for claims processing [4][5] - The center utilizes encrypted medical insurance data to streamline the claims process, allowing for quicker reimbursements without requiring patients to submit additional documents [4][5] Group 3: Market Implications and Future Outlook - Experts predict that 2025 will mark a pivotal year for the development of commercial health insurance, driven by enhanced data sharing and the introduction of a commercial health insurance innovation drug directory [6][7] - The commercial health insurance sector currently represents a small portion of the overall medical insurance framework, indicating significant growth potential as policies evolve [7][8]