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].

Core Viewpoint - The article discusses the introduction of the commercial insurance innovative drug directory in China, which supplements the basic medical insurance directory and aims to include high-priced innovative drugs that provide significant clinical value and patient benefits [2][10]. Summary by Sections Introduction of the Commercial Insurance Innovative Drug Directory - The National Healthcare Security Administration announced a list of drugs that passed the initial review for the commercial insurance innovative drug directory, with a total of 121 drugs, over half of which are cancer or rare disease medications [2][5]. - The directory is expected to include high-priced drugs, such as CAR-T therapies costing over 1 million yuan per injection and gene therapies priced around 98,000 yuan per injection [2][4]. Drug Approval and Characteristics - To qualify for the commercial insurance innovative drug directory, drugs must either be newly approved from January 1, 2020, to June 30, 2025, or have indications included in the national rare disease directory by June 30, 2025 [5]. - Among the 121 drugs, 57 are imported, accounting for 47%, with notable entries from companies like Pfizer and Johnson & Johnson [5]. Focus on Cancer and Rare Diseases - The majority of drugs that passed the initial review are cancer treatments, with over 40 entries, followed by 35 for rare diseases [5][6]. - The article highlights the potential for the directory to alleviate payment challenges for rare disease medications, with companies actively submitting applications [6]. Pricing and Negotiation Challenges - The pricing negotiation process for drugs in the commercial insurance directory remains uncertain, as it involves collaboration between the National Healthcare Security Administration, commercial insurers, and pharmaceutical companies [12][13]. - The article notes that the commercial insurance directory may serve as a "double insurance" for companies, allowing them to apply for both the basic medical insurance and the commercial insurance directories simultaneously [9]. Future Considerations and Recommendations - The article suggests that the implementation of the commercial insurance innovative drug directory requires further exploration and refinement, with recommendations for pilot programs in specific insurance products [14]. - It emphasizes the need for insurance companies to develop reasonable pricing mechanisms and improve data integration with basic medical insurance to enhance their pricing strategies [13][14].

Core Insights - The National Healthcare Security Administration (NHSA) has released a list of drugs that passed the preliminary review for the commercial insurance innovative drug directory, which is a new supplement to the basic medical insurance directory aimed at covering high-priced drugs [2][3] - A total of 121 drugs have passed the initial review, with over half being cancer or rare disease medications, including several high-cost therapies [2][5] - The final commercial insurance innovative drug directory is expected to be published between October and November 2023, following expert evaluations and price negotiations [2][3] Summary by Category Drug Characteristics - The drugs included in the commercial insurance innovative drug directory are characterized by high innovation, significant clinical value, and substantial patient benefits, exceeding the basic insurance's "basic protection" scope [2] - Among the 121 drugs, 57 are imported, accounting for 47%, with notable entries from companies like Pfizer, Johnson & Johnson, and Merck [5] Pricing and Negotiation - The drugs will undergo price negotiations, which may lead to price reductions, but the extent of these reductions remains uncertain [9][10] - The commercial insurance innovative drug directory allows for simultaneous applications to both the basic medical insurance and the commercial insurance directories, providing a "double insurance" for companies [7] Market Dynamics - The directory includes a variety of drugs, including CAR-T therapies priced around 1 million yuan per injection, which have faced challenges in entering the basic medical insurance directory [6][9] - The directory's implementation may alleviate payment difficulties for rare disease medications, with companies actively submitting applications [6][8] Insurance Industry Considerations - The insurance industry faces challenges in pricing and market growth potential due to the voluntary nature of commercial insurance participation [9][11] - There is a need for better data integration between commercial insurance and basic medical insurance to enhance pricing strategies and product development [11]

Core Insights - The article discusses the recent approval of several high-priced innovative drugs for the commercial insurance innovation drug directory, which were previously excluded from the basic medical insurance directory due to high costs [2][5] - Over 60% of the drugs included in the commercial insurance innovation drug directory have also applied for the basic medical insurance directory, indicating a dual strategy by pharmaceutical companies [2][5] - The National Healthcare Security Administration (NHSA) has initiated a new phase of expert reviews for these drugs, which will determine their final inclusion in the insurance directories [10] Group 1: Drug Approval and Market Dynamics - A total of 121 innovative drugs passed the preliminary review for the commercial insurance innovation drug directory, with 141 applications submitted [5] - Approximately 80 drugs applied for both the basic medical insurance and commercial insurance directories, highlighting a trend towards dual applications [5][9] - The article identifies five categories of drugs that were only submitted for the commercial insurance directory, including rare disease treatments and newly approved drugs with limited clinical data [3][4] Group 2: Pricing and Economic Considerations - Some high-priced rare disease treatments have annual costs exceeding 1 million yuan, which have previously failed to meet the basic medical insurance criteria [6] - The NHSA emphasizes that the approval for the basic medical insurance directory does not guarantee inclusion, as drugs must pass rigorous evaluations and negotiations [9] - The article notes that the commercial insurance directory may serve as a transitional option for innovative drugs that exceed the acceptable pricing thresholds for basic medical insurance [5][10] Group 3: Industry Perspectives and Future Implications - Industry experts suggest that the commercial insurance innovation drug directory should focus on new drugs that fill clinical gaps and provide differentiated treatment options [7] - There is a concern among pharmaceutical companies regarding the potential impact of drug inclusion on insurance premiums and patient access [10][11] - The article highlights the need for real-world evidence to support the clinical efficacy of some newly approved drugs, which may influence their acceptance in the basic medical insurance directory in the future [8][9]

Core Viewpoint - The article discusses the recent approval of high-priced innovative drugs for commercial insurance innovation drug directory, highlighting the ongoing negotiations for inclusion in the basic medical insurance directory, which remains the primary goal for most innovative drug companies [3][4][8]. Summary by Sections Approval Process - The National Medical Insurance Administration announced that 121 innovative drugs passed the preliminary formal review for the commercial insurance innovation drug directory, with a significant number also applying for the basic medical insurance directory [3][7]. - The review process assesses whether the drugs meet the criteria for inclusion in the insurance directories and the completeness of their information [7]. Drug Categories - Less than 40% of the drugs approved only for the commercial insurance innovation drug directory fall into five main categories: rare disease medications, newly approved drugs with limited real-world evidence, globally priced drugs that still do not meet basic insurance thresholds, high-priced new drugs for existing treatments, and preventive biological agents restricted by legal regulations [4][5]. Dual Directory Applications - Approximately 80 drugs, or about 60% of those in the commercial insurance innovation drug directory, applied for both directories, indicating a transitional strategy for many innovative drug companies [8]. - Many high-priced innovative drugs that exceed the acceptable value threshold for basic medical insurance are opting for single directory applications [8][10]. Market Dynamics - The competition in the market for cancer drugs and other treatment areas is intensifying, with a focus on "true innovation" and "differentiated innovation" as encouraged by the National Medical Insurance Administration [10]. - The article notes that some innovative drugs are being submitted for commercial insurance first, with the expectation that they may later be evaluated for inclusion in the basic medical insurance directory once sufficient real-world data is available [11]. Insurance Considerations - The decision to include innovative drugs in the commercial insurance directory is influenced by factors such as the drug's appeal to insurance products, potential premium increases, and the risk of excessive claims [14][15]. - The article highlights the differences in coverage and reimbursement capabilities across various regions, which may affect the sales pathways for innovative drugs [15].

Core Insights - This year, several high-priced innovative drugs that were previously excluded from the basic medical insurance directory due to the "invisible threshold" have passed the preliminary review for the commercial insurance innovative drug directory [1][2] - Over 60% of the drugs included in the preliminary review for the commercial insurance innovative drug directory are also applying for the basic medical insurance directory, indicating a dual strategy among pharmaceutical companies [1][4] - The National Medical Insurance Administration has published a list of 121 innovative drugs that passed the preliminary review for the commercial insurance innovative drug directory, reflecting a significant interest from pharmaceutical companies in gaining access to broader insurance coverage [3][8] Summary by Categories Innovative Drug Directory - A total of 141 applications were received for the commercial insurance innovative drug directory, with 121 passing the preliminary review, marking the first year this directory has been included in the adjustment process [3] - Approximately 40% of the drugs that only applied for the commercial insurance innovative drug directory are primarily rare disease medications, newly approved drugs with limited clinical data, and high-priced innovative drugs that do not meet the basic insurance entry threshold [2][4] Dual Directory Applications - About 80 drugs, or roughly 60% of those in the commercial insurance innovative drug directory, have also applied for the basic medical insurance directory, suggesting that the commercial directory serves as a transitional option for many innovative drug companies [4][9] - The drugs that opted for "single directory" applications are often those with high innovation and clinical value but priced significantly above the acceptable threshold for basic medical insurance [4][5] Pricing and Market Dynamics - The pricing of innovative drugs is a critical factor, with some drugs being priced at levels that are already the lowest globally, yet still not qualifying for basic medical insurance [6][8] - The competitive landscape for oncology drugs is intensifying, with companies considering the potential for inclusion in the commercial insurance directory as a means to enhance product attractiveness without significantly raising premiums [9][10] Future Considerations - The expert review phase for the drugs that passed the preliminary review will begin soon, with a focus on whether these drugs can be included in the commercial insurance directory and the basic medical insurance directory [9] - There is a growing sentiment in the industry that innovative drugs with uncertain clinical benefits may initially enter the commercial insurance directory before being reassessed for basic medical insurance inclusion based on real-world data [7][10]