Study: China outpaces the US in cancer approvals, lags behind on first approvals
While China's National Medical Products Administration (NMPA) approved more oncology drugs compared to the US Food and Drug Administration (FDA) from 2020 to 2025, the US regulator approved more first-in-class drugs and tended to approved products faster and earlier than China, according to a recent study published in Health Affairs.
However, the authors, Grace Collins, Divita Pandita, and their colleagues at the Friends for Cancer Research, found that NMPA approved more novel drugs than FDA in the latter half of the study period, indicating that China’s recent investments in the biomedical sector are paying off. The authors analyzed the evolution of two of the largest oncology drug markets, considering the implications for regulators, sponsors, clinicians, and patients.
From 2020 to 2025, FDA approved 87 oncology drugs, while NMPA approved 94. However, FDA completed its reviews a median of 182 days faster and granted approvals a median of 164 days earlier than the NMPA. Additionally, the FDA had a higher number of global first-in-class approvals, with 30, compared to just six by NMPA; while NMPA went on to approve 13 of the drugs approved first by FDA, FDA has yet to approve any of the six drugs approved first in China.
However, US’ advantage may be diminishing at earlier stages of development “as China's pipeline of first-in-class candidates has been grown rapidly in recent years.”
“China's growing role in oncology drug development has been well documented. Analyses of NMPA-approved oncology drugs show a rising share of domestically developed novel therapies and growing use of expedited pathways,” said the authors. “Chinese-origin oncology therapies are also increasingly entering global development pipelines, with their companies seeking FDA approval. At the same time, structural factors, including faster and lower-cost clinical trials, have contributed to China's expanding output of novel oncology therapeutics.”
The review also found that a significant majority of approvals were granted through expedited mechanisms: 87% for the FDA and 65% for NMPA. Furthermore, more than half of the FDA approvals—55%—received Breakthrough Therapy Designation, while NMPA used this designation less frequently, at only 32%.
In this study, the authors utilized publicly available drug databases from the FDA and the NMPA to gather information on novel oncology approvals in these two regions from 2020 to 2025. The findings were published on 10 July.
“The trend that the NMPA approved more novel oncology drugs than 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,” the authors wrote.
The authors determined the review timeline for each drug by calculating the number of days between the submission dates of the new drug applications and their approval dates from the FDA and NMPA.
The study revealed that applications for drugs approved by both the FDA and the NMPA were generally submitted to and approved by the FDA earlier. This trend indicates that the US remains the primary launch market for innovative therapies.
The authors noted that direct comparisons between agencies are limited due to the small number of shared drugs approved by both regulators during the time period in the study. The applications for drugs approved by both agencies were generally submitted to and approved by FDA first, establishing the US as “the initial market for innovative therapies.”
