A cross-national review of novel oncology approvals in the United States and China (2020-2025).

Introduction: The United States and China are among the largest hubs for oncology drug development and commercialization. We conducted a comprehensive characterization of how the 2 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 US Food and Drug Administration (FDA) and the National Medical Products Administration (NMPA), we collected information on novel oncology approvals in the United States and China from 2020 to 2025. Results: From 2020 to 2025, the FDA approved 87 oncology drugs, whereas the NMPA approved 94; most (87% FDA and 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 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 United States to ensure timely patient access to innovative oncology therapies.