Clinical, regulatory, and economic landscape of improved new drugs in China: a retrospective study of products marketed between 2020 and 2025

Abstract

Introduction In China, improved new drugs with known active ingredients, optimized through a new dosage form, formulation process, or administration route, have attracted increasing attention due to relatively low research and development risks and accelerated regulatory pathways. However, their clinical evidence, regulatory performance, and economic characteristics remain unclear. Methods We retrospectively reviewed all improved new drugs (Class 2.2 improved new drugs) approved and marketed in China between January 2020 and September 2025 using data from the YAOZH and Center for Drug Evaluation databases. We evaluated the following characteristics of each product: therapeutic area, dosage-form transition, clinical evidence type (bioequivalence [BE] or non-BE), duration of regulatory review, expedited-pathway designation, and price. Additionally, we identified published clinical trials on products supported by non-BE evidence. Price premiums were calculated as defined daily dose cost differences relative to the earliest marketed formulation of the same active pharmaceutical ingredient and indication. Results Across 14 International Classification of Diseases 11^th Revision categories, 71 products (70 chemicals and 1 traditional Chinese medicine) were approved. Overall, 53.5% were approved through BE evidence and 22.5% received priority review. The median review time was 551 days; priority reviews had significantly shorter timelines than standard reviews (374 vs. 582 days; P = 0.00027). Within the priority review cohort, non-BE approvals were non-significantly faster than BE approvals (P = 0.100). Among 30 products eligible for pricing analysis, the median price premium was 91.24% (interquartile range 46.35%-339.05%) relative to the earliest formulations. Conclusions Improved new drugs represent a pragmatic innovation route that balances development efficiency with regulatory accessibility. For standard reviews, non-BE evidence may facilitate faster approval; further, substantial price premiums were observed and may not consistently align with patient-centered values. Future studies should integrate usability, adherence, safety, real-world outcomes, and pharmacoeconomic evaluations in order to inform value-based reviews and reimbursements.

Keywords

improved new drugs / regulatory review / traditional Chinese medicine / price premium

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