Innovative Drugs Approved in China After Registration Classification Reform: Current Status, Disparities, and Challenges

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167 innovative drugs were approved in China, with 86.8% being domestic products and a focus on oncology.
Small molecules accounted for 58.1%, biologics for 31.1%, and Chinese medicines represented 10.8% of approvals.
Most oncology drugs were approved based on surrogate end-point evidence, with significant focus on biologics.
Regulatory flexibility for Chinese medicines was limited compared to small molecules and biologics, indicating disparities.

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Cross-sectional study analyzes innovative drugs approved by NMPA, highlighting disparities and challenges.

Zhu et al. (2025) studied this question.

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