Study China outpaces the US in cancer approvals

Key Takeaways

• From 2020 to 2025, NMPA approved 94 novel oncology drugs and FDA approved 87, with NMPA ahead each year from 2023 through 2025.
• FDA recorded 30 global first-in-class oncology approvals versus six at NMPA over the same window.
• FDA reviews ran a median 182 days faster; shared drugs were approved a median 164 days earlier in the US.
• Expedited pathways backed 87% of FDA and 65% of NMPA oncology approvals; Breakthrough Therapy Designation was used more often at FDA (55% vs 32%).

China–US oncology approvals at a glance

Field	Detail
Study	A cross-national review of novel oncology approvals in the United States and China (2020–2025)
Journal	Health Affairs Scholar (Friends of Cancer Research authors)
DOI	10.1093/haschl/qxag183
Novel oncology approvals	NMPA 94; FDA 87 (2020–2025)
Global first-in-class	FDA 30; NMPA 6
Review / approval lag	FDA median 182 days faster review; 164 days earlier approval on dual-approved drugs
Expedited use	FDA 87%; NMPA 65% (Breakthrough Therapy: FDA 55%; NMPA 32%)

What did the Health Affairs Scholar study find?

Grace Collins, Divita Pandita, and colleagues at Friends of Cancer Research compared novel oncology approvals using public FDA and NMPA databases for 2020–2025. Their paper, A cross-national review of novel oncology approvals in the United States and China (2020–2025), was published in Health Affairs Scholar (DOI 10.1093/haschl/qxag183).

Headline volume favors China in the later years of the window. NMPA's novel oncology output rose sharply from 2023 through 2025 and exceeded FDA counts in each of those years. Over the full six-year period, NMPA still edged ahead 94 to 87.

Why does the US still lead on first-in-class drugs?

Volume is not the same as first-mover innovation. The FDA logged 30 global first-in-class oncology approvals versus six at NMPA. Of drugs first approved in the US, NMPA later cleared 13. Of the six first approved in China, the FDA had not approved any during the study period.

That pattern supports the authors' view that the United States remains the primary launch market for many innovative therapies, even as China's absolute approval count climbs. Sponsors still tend to file and win first in the US when the same product is pursued in both markets.

How large is the review-time gap?

The authors measured days from new drug application submission to approval. FDA completed oncology reviews a median of 182 days faster than NMPA. For products approved by both regulators, FDA decisions came a median of 164 days earlier.

Applications for dual-approved drugs were also generally submitted to FDA first. The paper cautions that direct head-to-head comparisons are limited by the small shared set, but the timing pattern is consistent: earlier US filing and faster US review.

How often do expedited pathways appear?

Expedited mechanisms backed most oncology approvals in both countries — 87% at FDA and 65% at NMPA. Breakthrough Therapy Designation appeared in 55% of FDA oncology approvals versus 32% at NMPA.

Those tools help explain why US patients often see novel cancer drugs sooner. They also sit alongside other FDA transparency products, such as CDER's Novel Drug Approvals for 2025 listing, which continues to document first US clearances year by year.

What does this mean for sponsors and patients?

For global sponsors, the data cut two ways. China is producing more novel oncology approvals and is a growing development base. The US still offers faster reviews and more first-in-class wins, which matters for labeling, pricing strategy, and subsequent filings elsewhere.

For patients, higher Chinese volume does not automatically mean earlier access to the same first-in-class medicines. Shared drugs still tilted toward earlier FDA approval. Pipeline growth in China may narrow that gap over time — the authors note China's first-in-class candidate pipeline has expanded — but the 2020–2025 record still favors the FDA on speed and first-in-class count.

How should readers use FDA novel-approval tallies?

Annual FDA novel-drug tables are a useful US-side check, not a full China–US scorecard. FDA's Novel Drug Approvals hub lists CDER novel molecular entities and therapeutic biologics by calendar year and excludes many CBER products. The Friends analysis focuses specifically on novel oncology approvals at FDA and NMPA across 2020–2025, so its oncology totals will not match an all-indication CDER year list.

Readers comparing markets should stick to the paper's oncology definitions and dual-agency timing metrics rather than mixing them with broader novel-drug scorecards.

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Frequently Asked Questions

Primary Sources

1. Health Affairs Scholar / DOI: Cross-national review of novel oncology approvals in the US and China (2020–2025)
2. FDA: Novel Drug Approvals for 2025
3. FDA: Novel Drug Approvals at FDA hub