9月20日，国家医保局官网发布关于2025年国家基本医保目录及商保创新药目录调整通过形式审查的申 报药品专家评审阶段性结果查询的公告。 在有关部门、申报企业和评审专家的大力支持下，我们按照《2025年国家基本医疗保险、生育保险和工 伤保险药品目录及商业健康保险创新药品目录调整工作方案》组织专家对2025年通过国家基本医疗保 险、生育保险和工伤保险药品目录及商业健康保险创新药品目录（简称2025年国家基本医保目录及商保 创新药目录）调整形式审查的申报药品进行了评审。评审工作已结束，现公告如下： 一、各相关申报企业可自行登陆国家医保服务平台（https://fuwu.nhsa.gov.cn）"2025年基本医保目录及 商保创新药目录调整"模块（以下简称目录调整模块）查询评审结果。 二、专家评审结果为"拟简易续约""拟重新谈判续约""拟谈判新增""拟竞价新增""拟价格协商"的药品， 请相关企业在"目录调整模块"下载对应的"确认函模板"，按要求填写并加盖公章后于2025年9月23日 12：00前上传至"目录调整模块"，并于当日将原件寄送至国家医保局（以寄出邮戳为准）。请同步下载 对应的"资质材料"模板，并按要求报送。 ...

Core Insights - The new healthcare regulations set to take effect in 2025 will lead to the exclusion of certain medical expenses from insurance reimbursement, impacting patients financially [1][2][10] - The adjustments are necessary due to the increasing financial pressure on the healthcare insurance fund, driven by an aging population and rising medical costs [1][7] Summary by Categories Changes in Reimbursement - Five categories of expenses are likely to be removed from insurance coverage, including: 1. Certain auxiliary examinations and premium medical services, such as high-end health check packages and non-essential imaging tests [4] 2. Inefficient or replaceable medications, particularly those with low clinical value or cheaper alternatives [5] 3. Non-essential rehabilitation treatments and medical devices that do not directly impact disease treatment [6] 4. Specific traditional Chinese medicine treatments that are not deemed essential [6] 5. Non-emergency cross-regional medical services that do not follow referral procedures [6] Rationale Behind Adjustments - The adjustments aim to alleviate the financial strain on the healthcare fund by focusing resources on essential medical services [7] - The policy changes are designed to encourage rational medication use and medical service selection, reducing unnecessary healthcare expenditures [7] - The adjustments also promote the development of the domestic pharmaceutical industry by encouraging the use of innovative and cost-effective medications [7] Strategies for Patients - Patients are advised to understand the new insurance policies and their local variations to avoid unexpected costs [8] - Emphasizing tiered medical care by initially visiting primary healthcare facilities can enhance reimbursement rates [8] - Choosing medications and treatments within the insurance directory can significantly reduce personal expenses [8] - Staying informed about policy changes is crucial for adapting healthcare choices accordingly [8] - Considering supplemental commercial health insurance can provide additional coverage for high-end medical services or specialized medications [9] Positive Signals - Despite the exclusion of certain items from coverage, there are positive developments, such as the inclusion of new cancer drugs and rare disease medications in the insurance directory [10] - The adjustments reflect ongoing efforts to balance the sustainability of the healthcare fund with the medical needs of the population [10]

Core Viewpoint - Jichuan Pharmaceutical's financial performance continues to decline, with significant drops in revenue and net profit in the first half of 2025, raising concerns about the company's future prospects due to challenges from core product sales and ongoing medical procurement policies [1][2][3]. Financial Performance - In the first half of 2025, Jichuan Pharmaceutical reported revenue of 2.75 billion yuan, a year-on-year decrease of 31.9%, and a net profit of 724 million yuan, down 45.9% [2]. - The second quarter of 2025 saw revenue of 1.22 billion yuan, a decline of 25.03% year-on-year and 19.8% quarter-on-quarter, with net profit at 284 million yuan, down 42.39% year-on-year and 35.5% quarter-on-quarter [2]. Core Products and Market Challenges - The sales of Jichuan's key products, Pudilan Anti-inflammatory Oral Liquid and Children's Chiqiao Qingre Granules, have significantly decreased, with their combined sales accounting for only 49.51% of total revenue in the first half of 2025, down from 60.12% in 2024 [2][3]. - The decline in sales is attributed to changes in market demand and the impact of medical procurement policies, which have affected the pricing and availability of these products [2][4]. Historical Context - Jichuan's revenue surged from 7.63 billion yuan in 2021 to 9.655 billion yuan in 2023 due to increased demand for respiratory disease treatments, but has since fallen to a historical low in 2025 [3]. - The company's core product, Pudilan, has been removed from several provincial medical insurance catalogs, leading to decreased patient purchasing willingness [3]. Competitive Landscape - The market for Jichuan's products is becoming increasingly competitive, with numerous alternatives available, including well-known brands that pose a threat to Pudilan's market share [4][7]. - Jichuan's other important product, Rabeprazole Sodium Enteric-Coated Capsules, faces pricing pressures from national procurement policies, which could further impact its market position [4]. Strategic Initiatives and Challenges - Jichuan is attempting to diversify by entering the personal care and innovative drug markets, but results have been limited, with personal care products generating only 89 million yuan in sales in 2023 [5][6]. - The company has initiated collaborations for innovative drug development, but faces stiff competition in these areas, making it difficult to establish a strong market presence [6][7]. Research and Development Focus - Jichuan has historically prioritized marketing over research and development, with R&D expenses constituting only 5.55% of total revenue in 2024, which raises concerns about its ability to innovate effectively [6][8]. - The company has several products in the pipeline, but the competitive nature of the market poses significant challenges to their success [6][7].

Core Viewpoint - The sale of a 60% stake in the Sino-American Shanghai Bristol-Myers Squibb Pharmaceutical Co., Ltd. (SASS factory) by Bristol-Myers Squibb is significant as it marks a strategic shift in the company's operations in China, focusing on resource allocation and external collaboration to enhance its regional strategy and ensure long-term drug supply for patients globally [1][3]. Group 1: Company Actions - Bristol-Myers Squibb has signed an agreement to sell its 60% stake in the SASS factory, which was the first Sino-American joint venture pharmaceutical company established after China's reform and opening up in 1982 [1]. - The company aims to continue investing in the Chinese market under its "China 2030 Strategy," which includes plans to introduce nearly 30 innovative products or indications by 2025 and accelerate the introduction of more global innovations from 2026 to 2030 [4]. - The SASS factory primarily produces mature products, including various medications that have seen profit margins compressed due to China's centralized procurement policies since 2018 [3][4]. Group 2: Industry Trends - Other multinational pharmaceutical companies, such as Eli Lilly and GlaxoSmithKline, have also engaged in asset divestitures in China, focusing on mature products, indicating a broader trend in the industry [3]. - The Chinese government has implemented policies favoring innovative drugs, encouraging pharmaceutical companies to shift their focus towards innovation rather than relying on mature products [3][4]. - Bristol-Myers Squibb is adapting its strategy for its PD-1 monoclonal antibody, O drug, aiming to push for its inclusion in the national medical insurance directory to enhance market access and affordability for patients [5].

Core Points - The National Healthcare Security Administration (NHSA) announced changes to the drug list for basic medical insurance, with six drugs undergoing form review changes, including two drugs that did not pass the review [1][3] - The two drugs that failed the review are injectable risperidone microspheres and injectable triptorelin, both of which are exclusive products from Zhejiang Shengzhao Pharmaceutical Co., Ltd. and Ipsen, respectively [2][3] - The injectable risperidone microspheres have a global market size of $490 million in 2022, with expectations to reach 920 million yuan in China by 2030 [3] Drug Review Changes - Six drugs had their form review results changed, with injectable risperidone microspheres and injectable triptorelin being excluded from the basic medical insurance directory [3][4] - Injectable risperidone microspheres, approved in February 2023, is the first generic version in China for treating mental disorders, while injectable triptorelin was approved in 2023 for treating precocious puberty and prostate cancer [3][4] Commercial Health Insurance Innovations - The newly established commercial health insurance innovative drug directory has gained attention, with 121 drugs passing the form review, including CAR-T and nuclear medicine therapies [5] - CAR-T therapy has faced challenges in entering the insurance directory due to high costs, but five CAR-T products have now passed the form review for the commercial health insurance directory [5] - Nuclear medicine, known for its precision in targeting cancer cells, has also seen several products approved, including technetium-99m and fluorine-18 labeled drugs [6] Future Developments - Negotiations and price discussions for the drug directory adjustments will take place from September to October, with results expected to be announced in November [7]

Core Viewpoint - The annual adjustment of the national basic medical insurance (BMI) drug list has begun, with a significant increase in the number of drugs passing the preliminary review, indicating intensified competition for inclusion in the insurance coverage [3][5]. Summary by Sections Drug Approval and Competition - A total of 310 drug names passed the preliminary review this year, up from 249 in 2024, reflecting a growing number of innovative drugs approved [3][5]. - The number of first-class innovative drugs approved in China has shown a clear upward trend, with 48 approved in 2024, more than five times the number in 2018 [5]. Impact on Patients and Accessibility - The inclusion of innovative drugs in the BMI list significantly improves patient access, with over 70 anti-tumor drugs added from 2018 to 2024, addressing the issue of patients lacking available treatments [5][6]. - The pricing of new drugs is crucial for patient affordability, as high costs can limit access despite the availability of innovative treatments [7][8]. Pricing Negotiations and Challenges - The negotiation process for drug pricing involves expert evaluations and discussions with companies to establish mutually acceptable reimbursement standards [7][10]. - Balancing the need for affordable pricing with the necessity for companies to recoup R&D costs presents a significant challenge in the negotiation process [8][11]. Policy Directions and Innovation Support - The 2025 adjustment plan emphasizes maintaining fund security while encouraging innovation and optimizing the drug list structure [10][11]. - The focus is on supporting genuine innovation and ensuring that new drugs provide real clinical benefits, with a comprehensive evaluation of their value [10][12]. Real-World Data and Evaluation - The importance of real-world data in assessing drug effectiveness and safety is highlighted, as it provides insights beyond controlled clinical trials [14][15]. - The need for a robust drug value assessment system is increasingly urgent, as it informs decisions on funding and resource allocation [13][16].

Core Points - The annual adjustment of the national basic medical insurance catalog has begun, with the National Medical Insurance Administration announcing a list of drugs that have passed preliminary review, indicating increased competition for drug inclusion in the insurance catalog this year [1][3] - A total of 310 generic drugs passed the preliminary review, significantly up from 249 in 2024, reflecting a substantial increase in the number of innovative drugs approved [1][3] - The adjustment process involves expert evaluation, negotiation, and price consultation, with a focus on balancing drug pricing and patient accessibility [1][6] Group 1: Drug Approval and Inclusion - The National Medical Insurance Administration has been adjusting the drug catalog since its establishment in 2018, with 530 drugs added through negotiations, enhancing the accessibility of innovative drugs [3] - Over 70 anti-tumor drugs have entered the insurance catalog from 2018 to 2024, addressing the needs of patients with various cancers [3] - The approval of innovative drugs has surged, with 48 first-class innovative drugs approved in 2024, more than five times the number in 2018 [3] Group 2: Pricing and Negotiation - The negotiation process for drug pricing is crucial, as it determines the reimbursement standards and affects the financial viability of innovative drugs [6][7] - The challenge lies in finding a balance between drug pricing and patient accessibility, as high prices can limit patient access while low prices may hinder the return on investment for pharmaceutical companies [6][9] - The adjustment of the insurance catalog is seen as a way to optimize the use of limited medical resources and improve the efficiency of the insurance fund [4][6] Group 3: Innovation and Evaluation - The 2025 adjustment plan emphasizes supporting true innovation and optimizing the structure of the drug catalog while ensuring fund security [8][9] - The need for a comprehensive drug value assessment system is highlighted, focusing on real-world data to evaluate the effectiveness and safety of drugs post-approval [10][12] - The integration of health technology assessments (HTA) in drug pricing negotiations is noted as a practice that could enhance transparency and fairness in the process [13]

Core Insights - The competition for access to the national medical insurance (NMI) directory is expected to intensify this year, with a significant increase in the number of drugs passing the preliminary review [2][4]. Group 1: NMI Directory Adjustments - The annual adjustment of the national basic medical insurance directory has commenced, with 310 drug names passing the preliminary review, up from 249 in 2024, indicating a more competitive environment for drug access [2][4]. - Since the establishment of the National Medical Insurance Administration in 2018, there have been eight rounds of adjustments to the NMI drug directory, with 530 drugs added through negotiations, enhancing the accessibility of innovative drugs [4]. - The approval of innovative drugs has surged, with the number of first-class innovative drugs approved reaching 48 in 2024, over five times that of 2018, and nearly 40 approved in the first half of this year alone [4][5]. Group 2: Pricing and Negotiation - The negotiation process for drug pricing involves expert evaluations and discussions with companies to establish mutually acceptable reimbursement standards, referred to as "soul bargaining" [7]. - The pricing of newly approved drugs is often high due to substantial R&D investments, making affordability a critical factor for patients [7][8]. - The balance between low reimbursement prices, which may hinder innovation returns, and high prices, which could strain the insurance fund, is a significant challenge in the NMI directory adjustments [7][11]. Group 3: Innovation and Evaluation - The NMI adjustments emphasize supporting true innovation and optimizing the structure of the drug directory, with a focus on filling clinical gaps and encouraging differentiated innovations [9][10]. - The establishment of a comprehensive drug value assessment system is increasingly urgent, with a need for scientific methods to guide financial decisions in the NMI [12]. - Real-world data is crucial for evaluating the effectiveness and safety of drugs post-approval, and it is essential for adjusting reimbursement standards based on actual clinical outcomes [13][14].

Group 1 - The core viewpoint is that the expectation of interest rate cuts by the Federal Reserve has boosted market sentiment, leading to a rise in the Medical Innovation ETF (516820.SH) by 2.08% [1] - Key stocks in the sector, such as Haikang (002653), Kanglong Chemical (300759), Kanghong Pharmaceutical (002773), and WuXi AppTec (603259), have seen significant increases in their share prices, with gains of 7.81%, 6.63%, 6.33%, respectively [1] - The National Healthcare Security Administration has announced a plan for the adjustment of the drug catalog for basic medical insurance and commercial health insurance, establishing a dual-track system of "basic medical insurance + commercial insurance for innovative drugs" to alleviate pressure on basic medical insurance funds [1] Group 2 - The upcoming catalysts include the release of mid-year reports in August, with positive trends expected in the innovative drug sector and its supply chain, as some companies are already seeing a recovery in orders [2] - The approaching Innovative Drug Industry Conference in late August, along with updates from major cancer conferences like WCLC and ESMO, are anticipated to be significant events for the sector [2] - Domestic policy changes, including adjustments to the medical insurance catalog and the promotion of commercial insurance policies in the second half of the year, are also seen as important catalysts for the industry [2]

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]