A Cross-National Review of Novel Oncology Approvals in the United States and China (2020–2025)

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ID: 320469
2026
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Abstract
Abstract Introduction The United States (U.S.) and China are among the largest hubs for oncology drug development and commercialization. We conducted a comprehensive characterization of how the two largest oncology drug markets are evolving relative to one another, with implications for regulators, sponsors, clinicians, and patients. Methods Using publicly available drug databases from the U.S. Food and Drug Administration (FDA) and the National Medical Products Administration (NMPA), we collected information on novel oncology approvals in the U.S. and China from 2020 to 2025. Results From 2020 to 2025, the FDA approved 87 oncology drugs, compared with 94 by NMPA; most (87% FDA, 65% NMPA) were approved through expedited mechanisms. From 2023 to 2025, the NMPA’s approval volume increased and exceeded that of the FDA. Overall, the FDA reviewed drugs a median of 182 days faster, approved them a median of 164 days earlier, and had more global first-in-class (GFIC) approvals. Conclusion As regulatory capacity expands globally, cross-national comparisons help identify approaches that are working well and inform continued innovation and regulatory modernization in the U.S. to ensure timely patient access to innovative oncology therapies.
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Authors Grace Collins, Divita Pandita, Hillary S. Andrews, Bernat Navarro-Serer, Elena Levi-D’Ancona, Jeff Allen, Mark Stewart
Journal Health Affairs Scholar
Year 2026
DOI
10.1093/haschl/qxag183
URL
https://doi.org/10.1093/haschl/qxag183
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