China approved more novel oncology drugs than the United States from 2020 to 2025, according to a new analysis from Friends of Cancer Research published in Health Affairs Scholar.
During the six-year study period, FDA approved 87 novel oncology drugs, compared with 94 approved by China’s National Medical Products Administration, or the NMPA. The NMPA’s approval volume increased substantially from 2023 to 2025 and exceeded the FDA’s during each of those years.
Despite the NMPA’s growth in overall approvals, FDA retained important advantages. Overall, FDA reviewed oncology drugs a median of 182 days faster and approved five times as many global first-in-class therapies. Among the 14 drugs approved by both agencies, FDA approved them a median of 164 days earlier.
“The United States remains a global leader in bringing truly novel cancer therapies to patients,” Jeff Allen, president and CEO of Friends of Cancer Research, said in a statement. “But China’s rapid growth demonstrates that leadership cannot be taken for granted. Sustaining U.S. competitiveness and timely patient access will require continued investment in regulatory science, predictable development pathways, and a research infrastructure equipped to keep pace with innovation.”
Expedited regulatory mechanisms supported most oncology approvals in both countries, accounting for 87% of FDA approvals and 65% of NMPA approvals. Their widespread use reflects the growing importance of regulatory tools designed to accelerate the development and review of promising therapies for serious diseases.
The analysis also highlights the value of cross-national collaboration as clinical research and regulatory capacity expand globally. Understanding where different systems are succeeding can help inform continued modernization in the U.S. and ensure that patients maintain timely access to innovative oncology therapies.
“This is not simply a competition over the number of approvals,” Allen said. “The real measure of a regulatory system is whether it can move quickly, support meaningful innovation, and give patients timely access to transformative therapies. The FDA continues to lead in several of those areas and strengthening that foundation must remain a national priority.”