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

Introduction

The US Food and Drug Administration (FDA) has played a central role in global oncology drug development, pioneering several expedited regulatory mechanisms such as the Breakthrough Therapy Designation, Accelerated Approval Program, and Priority Review to accelerate patient access to novel therapies and strengthen domestic biopharmaceutical innovation. 1 Alongside modernization efforts in other major markets, China's National Medical Products Administration (NMPA) has also implemented substantial legal reforms to its drug regulatory system, initiated in 2015 and accelerated by China's accession to the International Council for Harmonisation (ICH). Reforms included expanded expedited pathways (eg, Priority Review, Conditional Approval, Breakthrough Therapy), acceptance of foreign clinical data, and alignment with international standards. An overview of FDA and NMPA expedited regulatory programs, including key reforms and their dates of implementation, is presented in Table 1 . As a result, China's regulatory landscape for oncology drug development and approval has evolved substantially in recent years. 8 , 9

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. 10-12 Chinese-origin oncology therapies are also increasingly entering global development pipelines, with their companies seeking FDA approval. 13 , 14 At the same time, structural factors, including faster and lower-cost clinical trials, have contributed to China's expanding output of novel oncology therapeutics. 15 , 16 While prior work has examined individual approval pathways, specific drug classes, or launch delays between the 2 markets, a broader comparison of novel oncology approvals across both agencies has not yet been reported.

We conducted a cross-national review of novel oncology drug approvals in China and the United States from 2020 to 2025, analyzing approval volume, review timelines, and expedited pathway use. We focused on this period to characterize approval patterns following the most recent wave of NMPA regulatory reforms, leveraging approval data documented across both agencies. These findings provide 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 FDA and the NMPA, we collected information on novel oncology approvals (ie, initial marketing authorizations for new molecular entities and biologics for oncology indications) in the United States and China from 2020 to 2025. We excluded supplemental approvals, drugs intended solely for managing physical and psychological side effects of cancer and cancer treatment(s) (ie, supportive care drugs), drugs approved for benign tumors or non-malignant conditions, and Traditional Chinese Medicines. Appendix Table AS1 lists all FDA and NMPA novel oncology drug approvals included in our analysis.

FDA approvals

We identified novel oncology approvals from the FDA's Oncology (Cancer)/Hematologic Malignancies Approval Notifications webpage. 17 For each approval, we compiled characteristics including application number, submission and approval dates, expedited regulatory programs (ie, Accelerated Approval, Breakthrough Therapy Designation, and Priority Review), and indications from publicly available approval and review documents in the Drugs@FDA database. For cell therapies approved by the FDA's Center for Biologics Evaluation and Research (CBER), we collected information from approval and review documents published on the FDA's webpage for Approved Cellular and Gene Therapy Products. 18 We also referenced the FDA's Center for Drug Evaluation and Research's (CDER) Annual New Drug Approval Reports to identify US first-in-class approvals. 19

NMPA approvals

We identified novel oncology drugs using the NMPA's Center for Drug Evaluation (CDE) Annual Drug Review Reports, focusing on appendices titled “ Innovative Drugs Approved by the National Medical Products Administration” (2023-2025) 20-22 or “Innovative Drugs Recommended for Approval by the Center for Drug Evaluation” (2020-2022). 23-25 These appendices include only Class 1 Innovative Drugs, which NMPA defines as “Innovative drugs that have not been marketed in China or overseas. They refer to drugs that contain new compounds with clear structures and pharmacological effects, and have clinical values.” 26 This classification is made at the time of submission to the NMPA. Therefore, some imported drugs that had not yet been approved abroad at the time of NMPA submission, but were approved elsewhere prior to NMPA approval, are considered Class 1 drugs.

For each novel oncology drug, we collected CDE and NMPA application numbers, generic name (Chinese and English), indication, application receipt and approval dates, and accelerated marketing procedures (ie, expedited programs including Conditional Approval, Breakthrough Therapy, and Priority Review). We supplemented data from the CDE's annual reports with Technical Review Reports for Marketing Authorization Applications, published in the “Information on Marketed Drugs” subsection of the CDE Information Disclosure database. 27 Documents were translated using Google Translate.

As of June 2026, the CDE had not published the Technical Review Reports for several novel oncology drugs approved in 2025. We supplemented these data using information from the “Accepted Variety Information” subsection of the CDE's database 28 and further validated the dataset against peer-reviewed publications detailing China's novel drug approvals. 8 , 9 , 29

Expedited programs

Our analysis of expedited regulatory mechanisms focused on Breakthrough Therapy Designation, Accelerated Approval (FDA)/Conditional Approval (NMPA) Program, and Priority Review, as these FDA mechanisms have direct counterparts at the NMPA. Although other expedited mechanisms exist, including the FDA's Fast Track and the NMPA's Special Approval, these were not considered in this analysis.

Review timelines

We calculated each drug's review timeline as the number of days between the new drug application submission and approval dates (FDA) or the receipt and approval dates (NMPA). For one FDA approval and one NMPA approval, 2 submission or receipt dates were recorded (each within 1-2 days). For these drugs, we used the submission or receipt date closest to the approval date.

Global first-in-class therapies

For each drug, we identified its mechanism of action and molecular target, and reviewed published literature, pharmaceutical company communications, and regulatory disclosures to determine whether it represented the first approved therapy with that mechanism–target pair by either the FDA or the NMPA. For FDA approvals, we also reviewed the FDA's publicly available Annual Novel Drug Approval Reports, which identify first-in-class approvals as drugs that “produce a novel pharmacologic effect, the impact or influence that a drug has on the body or a specific biological target, in a disease.” 19 Drugs were classified as global first-in-class (GFIC) if they represented a novel mechanism–target pair not previously approved for any indication by either the FDA or the NMPA (additional information on each GFIC drug is provided in Appendix Table AS1 ).

Results

During the 6-year period analyzed (2020-2025), the FDA approved fewer novel oncology drugs ( n = 87) than the NMPA ( n = 94). While the FDA approved more drugs than the NMPA from 2020 to 2022, the NMPA's approval volume exceeded that of the FDA from 2023 to 2025 ( Figure 1 ). Some drugs were approved for multiple indications; in total, the FDA approved 91 indications and the NMPA approved 96. Subsequent analyses focus on unique drugs rather than drug–indication pairs.

Across both agencies, most novel oncology drugs were approved through expedited programs, with 87% ( n = 76/87) of FDA approvals and 65% ( n = 61/94) of NMPA approvals using at least one expedited program ( Table 2 ). Use of expedited programs and their impact on review timelines differed between the 2 agencies.

Priority Review was the most frequently used expedited mechanism for both the FDA (84%, n = 73/87) and the NMPA (57%, n = 54/94) ( Table 2 ). Accelerated Approval (FDA) 30 and Conditional Approval (NMPA) 6 were also frequently used (FDA: 52%, n = 45/87; NMPA: 49%, n = 46/94) ( Table 2 ). More than half of FDA approvals (55%, n = 48/87) received Breakthrough Therapy Designation, while NMPA approvals used this designation less frequently (32%, n = 30/94) ( Table 2 ).

Reviews conducted under at least one expedited program had shorter median timelines than nonexpedited reviews. Expedited FDA reviews were conducted a median of 119 days faster than nonexpedited reviews. Expedited NMPA reviews were conducted a median of 149 days faster than nonexpedited reviews ( Table 2 ). Drugs receiving Breakthrough Therapy Designation had the shortest median review time at both the FDA (228 days) and the NMPA (320 days). However, most drugs had multiple expedited designations at the FDA (74%, n = 64/87) and the NMPA (50%, n = 47/94), so reductions in review timelines cannot be attributed to any single program ( Table 2 ). Across all categories, FDA review timelines were shorter than those of the NMPA.

Drugs approved by both the FDA and the NMPA

Between 2020 and 2025, 14 novel oncology drugs were approved by both the FDA and the NMPA ( Table 3 ). Drugs approved by either agency outside the study period were not included in this analysis. For example, zanubrutinib, originally approved by the FDA in 2019 and by the NMPA in 2020, was not included as an overlapping approval.

Most of these dually approved drugs were first submitted to (71%, n = 10/14) and approved by (79%, n = 11/14) the FDA. Applications were submitted to the FDA a median of 57 days earlier than to the NMPA and were approved by the FDA a median of 164 days earlier than by the NMPA. FDA reviews were conducted a median of 117 days faster than NMPA reviews.

Global first-in-class drug approvals

We compared the landscape of first-in-class approvals between the 2 countries. Among the 167 novel oncology drug approvals, 36 were classified as GFIC. The FDA approved most GFIC drugs first ( n = 30/36, 83%), while the NMPA approved 6 first. The NMPA subsequently approved 13 of the FDA's 30 GFIC drugs, most as imported original drugs rather than Class 1 innovative new medicines. As of June 2026, none of the 6 GFIC drugs first approved by the NMPA had received FDA approval.

Discussion

We assessed how the FDA and the NMPA approached the review and approval of novel oncology therapeutics from 2020 to 2025. While the FDA approved more novel oncology drugs in the first 3 years of our study period (2020-2022), the number of NMPA approvals increased notably from 2023 to 2025. The NMPA reached its highest annual approval count in 2025, reflecting continued growth in China's oncology pipeline.

Both agencies use expedited programs to facilitate development, review, and approval of promising therapies. FDA reviews were completed faster, but both regulators widely used expedited pathways, which were associated with shorter review timelines within each agency. Differences in review timelines likely reflect a combination of expedited processes, development maturity at submission, and sponsor filing strategies.

Direct cross-agency comparisons are limited by the small number of shared drugs approved by both regulators during the period analyzed. Applications for the drugs approved by both agencies were typically submitted to and approved by the FDA earlier, positioning the United States as the initial market for innovative therapies. The FDA also approved more GFIC drugs than the NMPA, reinforcing the United States' role in the early availability of first-in-class therapies. This advantage may be narrowing at earlier stages of development, as China's pipeline of first-in-class candidates has grown rapidly in recent years. 14 Yet approved first-in-class oncology drugs in our dataset remained concentrated at the FDA during the study period. However, the limited overlap in approvals, along with rising NMPA approvals, suggests that a growing share of innovation in China may be emerging from domestic pipelines. As NMPA approval volume increases and expedited review mechanisms expand globally, traditional advantages of early U.S. approval may diminish.

These findings have direct implications for patients, clinicians, sponsors, and regulators. 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. 31 , 32 Structural factors, including faster clinical trial initiation and enrollment, as well as lower costs, in China, may further influence these decisions. 13 , 14 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 limitations of this analysis include its focus on initial approvals and review of a limited number of expedited pathways. Subsequent regulatory decisions for supplemental indications or label expansions, as well as post-approval regulatory actions, including label modifications or withdrawals for Accelerated and Conditional Approvals, were not assessed, limiting characterization of the full scope of oncology innovation and regulatory activity in the United States and China. Additionally, imported original drugs, categorized separately by the NMPA, were included only if they were Class 1 Innovative Drugs. Comparisons of expedited regulatory mechanisms were limited to Breakthrough Therapy Designation, Accelerated Approval, and Priority Review, as these programs have direct counterparts within the NMPA. Additional expedited programs such as Fast Track (FDA) and Special Approval (NMPA) were not evaluated, which may underestimate the proportion of oncology approvals utilizing expedited pathways in the United States and China. Classification of GFIC therapies was based on prior approvals at the FDA and the NMPA only and did not assess approvals by other regulatory agencies globally.

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. 10 , 11 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. 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.

Supplementary Material

Acknowledgments

We thank Yan Zhang, Regulatory Analyst at Roche, for guidance on navigating China's Center for Drug Evaluation databases.

Supplementary material

Supplementary material is available at Health Affairs Scholar online.

Notes

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