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Tsinghua Clinical Research Institute, School of Medicine, Tsinghua University, Beijing, China. *These authors contributed equally: Guanqiao Li, Yang Liu.
Tsinghua Clinical Research Institute, School of Medicine, Tsinghua University, Beijing, China. *These authors contributed equally: Guanqiao Li, Yang Liu.
Scientific and technological advances, in combination with government incentives and regulatory reforms, have fuelled strong new drug R&D activities in China. To analyse these changes, we studied therapeutic agents originating in China or in-licensed by Chinese companies that have entered clinical development but not received marketing authorization in any country (domestic investigational agents). Agents were divided into three categories based on the drug target, mechanism of action (MoA) and the most advanced development stage in comparison to global counterparts. Drugs with novel target(s) or novel MoAs that do, or do not, have class-leading clinical development status worldwide are defined as first-in-class or fast-follower, respectively. Those with the same targets and similar MoAs to already-approved drug classes are considered me-too. For details of the dataset and analysis, see Supplementary Box 1.
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Nature Reviews Drug Discovery21, 553-554 (2022)
doi: https://doi.org/10.1038/d41573-022-00058-6
Acknowledgements
The authors gratefully acknowledge Yunhe Qin (Pharmcube) and Yale Jiang (Tsinghua University) for their contribution to the work.
Updates & Corrections
Correction 08 April 2022: The article has been corrected to state that 35 new domestic drugs and vaccines were approved by the NMPA in 2021, rather than 69 as originally stated; 69 is actually the number of domestic and imported drugs approved in 2021.