A Friends of Cancer Research paper indicated that while China has rapidly gained ground and even surpassed the US in the number of oncology therapies approved each year, the US remains the clear leader in approving first-in-class medicines.
China’s National Medical Products Administration (NMPA) is outpacing the US Food and Drug Administration in the number of novel oncology medicines approved annually, but the FDA remains the leader in approving first-in-class medicines, a new analysis found.
A recent article in Health Affairs Scholar from researchers affiliated with the Friends of Cancer Research’s advocacy organization attempted to inform the debate about strengthening US biotechnology competitiveness in the wake of China’s rapid emergence in the field.
The researchers found that the FDA approved 87 novel oncology drugs compared to the NMPA’s 94 between 2020 and 2025. The NMPA especially increased the number of approvals from 2023 to 2025 after the FDA lead in oncology approvals from 2020 to 2022, the authors said.
The NMPA lead in approval volume, but other metrics continue to favor FDA. The speed of FDA reviews remained faster than the NMPA throughout the five-year period, with a median overall review time of 235 days at the FDA vs. 417 days at the NMPA.
The paper highlighted 14 drugs approved by both regulators during the study period. Of those, 10 (71%) were submitted to the FDA first and 11 (79%) were approved by the FDA first.
The 14 applications were “approved by the FDA a median of 164 days earlier than by the NMPA.”
The relatively small number of drugs approved by both regulators during the period is notable. The authors said the head-to-head analysis does not consider drugs where one agency acted either before or after the study period.
The FDA cleared 30 first-in-class agents before the NMPA, far more than the six cleared by the Chinese regulator before the FDA. The paper also said the FDA has not yet approved any of the six therapies China approved first.
“These findings have direct implications for patients, clinicians, sponsors, and regulators,” the authors said. “The increasing volume of novel oncology approvals across both agencies, and the NMPA’s recent growth in particular, reflects expanding global access to new oncology treatments. At the same time, as expedited pathways become standard across major regulatory agencies, regulatory predictability and consistency may matter as much as review speed in determining where sponsors prioritize early development and first submissions.”
“Structural factors, including faster clinical trial initiation and enrollment, as well as lower costs in China, may further influence these decisions,” they said. “These dynamics underscore the value of continued investment in regulatory capacity and pathway clarity in both countries, as well as the potential benefits of international regulatory collaboration in oncology drug development.”
The authors also wrote that the NMPA’s novel oncology approval total exceeding the FDA from 2023 through 2025 “signals that China’s investment in domestic biomedical research and innovation is translating into greater output of new oncology treatments, reflecting regulatory reforms, expanded capacity, and structural advantages such as faster clinical trial enrollment.”
“Cross-national comparisons of this kind offer an opportunity to identify approaches that are working well globally and consider how lessons from other regulatory systems might inform continued improvements at the FDA,” they wrote. “As the NMPA approval volume continues to grow, examining what is driving these trends can help inform efforts to ensure the FDA continues to facilitate timely patient access to innovative oncology therapies.”
The FDA is responding to China’s rise in the biotech space with efforts to streamline early drug development in the US. An IND reform pilot program launched Sept. 15 that is intended to help sponsors avoid clinical holds and other mistakes as well as push products to first-in-human testing faster.
The pilot also is intended to encourage sponsors to conduct early-stage clinical trials in the US after China surpassed it in Phase I starts.
Editor’s Note: This story has been updated to reflect the correct author.