Core Insights - The national medical insurance negotiation for 2025 has introduced a dual-directory system, marking a significant change in the negotiation process for innovative drugs and commercial insurance [1][2][15] - The negotiation process for innovative drugs has seen a price reduction range suggested by the National Medical Insurance Administration (NMIA) of 15% to 50%, with a focus on the CAR-T drugs [3][4] - The introduction of the innovative drug directory is expected to create a more sustainable market payment mechanism for new drugs, with companies needing to reassess their product positioning and market strategies [15] Summary by Sections National Medical Insurance Negotiation - The negotiation took place from October 30 to November 3, 2025, with the first three days dedicated to the national medical insurance directory and the last two days for the commercial insurance innovative drug directory [1] - This year marks the first introduction of an innovative drug directory, which has altered the negotiation dynamics for drug pricing [1][15] Price Negotiation Mechanism - The NMIA has introduced a new price negotiation mechanism for innovative drugs, allowing for price discussions between drug companies and commercial insurance [1][3] - Companies have been advised to consider a price reduction of 15% to 50% during negotiations, with some expressing skepticism about achieving reductions below 15% [3][4] CAR-T Drugs - CAR-T drugs have been a focal point in the negotiations, with successful negotiations reported for some products, such as the CAR-T drug from HeYuan Biotech priced at 999,000 yuan [3][4] - A limited number of CAR-T drugs are expected to be included in the innovative drug directory, with estimates suggesting around 20 drugs may be approved [1][3] Commercial Insurance Dynamics - The dual-directory negotiation allows companies to choose between reporting to the basic medical insurance directory, the innovative drug directory, or both, creating strategic options for different companies [2][10] - The commercial insurance market has shown limited interest in covering rare disease drugs due to their high costs and small patient populations, which may affect their inclusion in the innovative drug directory [14][15] Focus on ADC and Bispecific Antibodies - ADC (Antibody-Drug Conjugates) and bispecific antibodies remain key focus areas in the negotiations, with several innovative drugs vying for inclusion in the directories [8][10] - Companies are adopting varied strategies based on their market positioning, with some prioritizing the basic medical insurance directory for broader market access, while others focus on maintaining high-end product positioning through the innovative drug directory [10][11]

Core Insights - The National Healthcare Security Administration (NHSA) announced the review results for the 2025 National Basic Medical Insurance (BMI) catalog and the first version of the commercial health insurance innovative drug catalog, marking a critical phase in the "dual catalog" adjustment process [1] - In the first year of the "dual catalog" discussions, 534 products passed the initial review for the BMI catalog, while 121 drugs were included in the commercial insurance innovative drug catalog, with over 60% of the 121 drugs being "double reported" [1][2] - The "double reported" drugs reflect the pharmaceutical companies' uncertain mindset regarding drug pricing negotiations in the BMI process, with high-priced drugs often targeting commercial insurance while others focus on BMI [2][3] Group 1: Drug and Company Analysis - A total of 79 drugs from 74 companies were "double reported," with 4 companies reporting two or more drugs, indicating a competitive landscape among pharmaceutical firms [1][3] - The "double reported" drugs include various categories, such as 19 rare disease drugs and 3 CAR-T therapies, showcasing a diverse range of therapeutic areas [1][5] - The highest annual treatment cost among the "double reported" drugs is approximately 1.5 to 2 million yuan for a rare disease drug from Takeda, highlighting the financial implications for both companies and patients [8][9] Group 2: Market Dynamics and Strategies - The "double reporting" strategy is seen as a low-cost strategic exploration for companies, allowing them to gauge market responses without significant investment [3][4] - Companies are motivated to participate in both catalogs to avoid being at a disadvantage if competitors succeed in securing listings in one while they do not [3][4] - The overall pass rate for the commercial insurance innovative drug catalog is estimated to be below 30%, indicating a challenging environment for companies seeking approval [4][9] Group 3: Insights on Rare Diseases and CAR-T Therapies - Rare disease drugs face significant hurdles in entering the BMI catalog, with only 13 out of 48 rare disease drugs passing the initial review in 2024, suggesting a low success rate [9][10] - CAR-T therapies are viewed as having a better chance of entering the commercial insurance catalog, with companies adjusting their strategies based on past experiences in BMI negotiations [10][11] - The pricing strategies for CAR-T drugs reflect a calculated approach, with companies aware of the need to control costs to meet BMI requirements while also targeting commercial insurance [10][11] Group 4: Cross-National Company Participation - Among the "double reported" drugs, 14 are from 10 multinational companies, indicating a strong interest from global players in the Chinese market [20][21] - The competitive landscape includes multiple drugs targeting similar conditions, leading to a scenario where companies are closely monitoring each other's submissions [22][23] - The performance of these drugs in commercial health insurance products, particularly in the context of "惠民保" (Hui Min Bao), has been promising, providing a potential pathway for future approvals [26][28]

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]