The US has been a leader in drug development for multiple decades, bringing new therapies to patients as quickly as possible.1,2 Recently, though, regulatory leaders abroad, particular in China, have implemented new policies to improve their drug development pipelines.3
These changes caught the attention of researchers at Friends of Cancer Research, a nonprofit organization that meets with stakeholders in the drug development and approval process and compiles evidence for potential policies to guide these sectors. Mark Stewart, the vice president of science policy at the organization, and his team compared the number of cancer drug approvals from China and the US to provide insights in these trends.
In a study published in Health Affairs Scholar, the team showed that China approved more novel cancer drugs than the US between 2020 and 2025, with the biggest increase in the last three years of the study period.4 However, the US’s Food and Drug Administration (FDA) still has a faster median review time for individual drug applications compared to the National Medical Products Administration (NMPA), China’s regulatory agency.
“This isn't a story that the US has lost its leadership by any means, but it is definitely providing some insights, and I think adds to the story that the competitive landscape and the drug development landscape is changing quickly,” Stewart said.
For this investigation, the team accessed the cancer drug approval information for each country from the respective agency’s database, identifying 167 relevant products. In addition to the total number of approved drugs, they also studied the average review time and expedited pathway used for the individual applications. The team also evaluated the indicated mechanism of action and target for each drug and cross-referenced this with those previously published to determine if the candidate represented a first-in-class drug. First-in-class therapies are a proxy for a country’s drug innovation.
Between 2020 and 2022, the FDA approved 1.8 times more cancer drugs than the NMPA, China’s drug regulatory agency. In the last three years, the NMPA approved 1.7 times more drugs than the FDA. This shift illustrates the changing landscape of drug development.
Janette Lee-Latour/adapted from Collins et al., 2026, CC-BY-NC 4.0
Between 2020 and 2025, the FDA approved 87 new cancer drugs while the NMPA approved 94. While the total number of approvals is comparable, China approved more oncology drugs in each of the last three years of the study period than the US, whose drug approval rate remained relatively consistent. Stewart said that this introduces important questions about how the US can remain competitive in the drug development landscape.
Looking at the speed of each country’s drug review and approval, the majority of applications submitted to the regulatory agencies used some form of expedited program. Compared to those oncology drug applications that were not put on an accelerated review, the FDA reviewed their candidates on an expedited pathway a median of 119 days faster, while similar review processes at the NMPA decreased the review time of their applications by a median of 149 days. Overall, the FDA reviewed cancer drug applications faster than the NMPA.
These findings, Stewart noted, suggest that the FDA’s review speed is not a factor that immediately needs to be improved. He said that upstream factors, like the time of initiation and enrollment for clinical trials, as well as their costs, could be important to explore as ways to improve the drug development pipeline.
Finally, the group evaluated the number of first-in-class therapies represented in their dataset. Of the 167 drugs approved by both countries in the study period, 36 were first-in-class therapies. The FDA approved 30 of these drugs first, 13 of which the NMPA subsequently approved as well. As of the end of the study period, the FDA had not approved any of the six first-in-class drugs approved by the NMPA.
So-Yeon Kang, a health policy researcher at Georgetown University who was not involved in the study, said that the findings were interesting. She added that many drug prices are currently based on the assumption that the US is the major drug developer. “We need to pay more attention and also monitor the trends and what are the potential implications of all these signals of the changes because the drugs are really needed for patients,” she said.
Kang previously studied the how recent changes impacted China’s early-stage drug development. “Now their regulatory reform is actually seeing the results of their investment in the system,” she said, but she pointed out that the current study did not directly evaluate if those changes influenced the current number of approvals. “This is a descriptive study documenting the recent trend. So, we will need to understand what [drives the] underlying forces of these changes and differences.”
- Okuyama R. Shifting global drug discovery landscape and the critical role of startups in strengthening national capabilities. Drug Discov Today. 2026;31(1):104576.
- Kneller R. The importance of new companies for drug discovery: Origins of a decade of new drugs. Nat Rev Drug Discov. 2010;9(11):867-882.
- Zhu X, Ziao D. Innovative drugs approved in China after registration classification reform: Current status, disparities, and challenges. Clin Pharmacol Ther. 2026;119(2):470-479.
- Collins G, et al. A cross-national review of novel oncology approvals in the United States and China (2020-2025). Health Aff Sch. 2026;4(7):qxag183.
