2025年中国批准上市创新药，30款已纳入医保

Core Insights - In 2025, the National Medical Products Administration approved 76 innovative drugs, marking a record high and showcasing a trend of diversified innovative therapies accelerating in China, significantly enriching clinical treatment options for domestic patients [1] Group 1: Drug Approval Overview - Among the approved drugs, 47 are chemical drugs, 23 are biological products (including 10 antibody drugs, 4 recombinant proteins, 3 cell gene therapies, 3 antibody-drug conjugates, 1 gene therapy, and 1 peptide), and 6 are traditional Chinese medicines [1] - The oncology sector remains the most concentrated area for new drug approvals, with 34 new drugs, including various types such as small molecules, monoclonal antibodies, and cell therapies [3] Group 2: Disease-Specific Drug Approvals - Breast cancer leads with 9 new drugs, including 3 CDK4/6 inhibitors and 2 CDK2/4/6 inhibitors, along with the first domestic AKT inhibitor and two antibody-drug conjugates targeting Trop2 and HER2 [3] - The field of infectious diseases saw significant approvals, including 4 influenza treatment drugs that target the influenza virus RNA polymerase PA subunit, which can alleviate medication shortages during peak flu seasons [6] - Immunological and metabolic diseases also saw a concentration of new approvals, with 8 and 7 new drugs respectively, including treatments for plaque psoriasis and type 2 diabetes [6] Group 3: Breakthrough Therapies - The quality of innovative drugs in the Chinese market has improved, with 17 of the approved drugs recognized as breakthrough therapies, indicating a significant advancement in both quantity and quality [7][11] - Notably, 12 of the new drugs are ranked first globally in their respective categories, and 31 are in the top three, reflecting China's leading position in drug development [7] Group 4: Insurance Coverage and Accessibility - The National Healthcare Security Administration has accelerated the inclusion of innovative drugs into the national insurance catalog, with 30 out of 43 new drugs approved in the first half of 2025 successfully entering the insurance directory, achieving a coverage rate of 70% [13] - This rapid inclusion is particularly significant for drugs addressing unmet clinical needs, such as the high-selectivity MEK1/2 inhibitor that covers rare tumors lacking standard treatment options [14][15] - The establishment of a commercial health insurance directory for innovative drugs further enhances accessibility, with two drugs from the 2025 approvals included, reducing out-of-pocket expenses for patients [16]