Improving access to domestic innovative medicines: characteristics and trends of approved drugs in China 2010–2024

•Drug regulatory reform has promoted the development and launch of domestic innovative drugs.•The time for each stage from clinical application to marketing shortened post-reform.•The accelerated drug marketing registration procedures showed advantages in speeding up the marketing of innovative drugs.•An increasing number of domestic innovative drugs have been incorporated into medical insurance. China has initiated drug regulatory reforms since 2015. Here, we analyze the characteristics and trends of domestic innovative drugs approved for marketing in China from January 2010 to May 2024 to explore the effectiveness of drug regulatory reform. Overall, 219 drugs were approved, with growth in chemicals and therapeutic biologics post-reform. Single-arm trials as an important option for clinical trial design of antineoplastic agents increased. The time for each link from investigational new drug (IND) to new drug application (NDA) has been shortened post-reform. Moreover, the time for access to medical insurance for approved drugs has been shortened and price reductions have been increased. China’s drug regulatory reforms have made progress in improving the accessibility of domestic innovative drugs.