China approved more cancer drugs than the FDA over six years, and reviewed them slower

The standard framing of Chinese biopharma is that it produces enormous volume and follows rather than leads. A cross-national comparison published on 10 July puts numbers on both halves of that claim, and the numbers do not agree with each other [s1].

What was compared

The authors used publicly available drug databases from the US Food and Drug Administration and China's National Medical Products Administration to assemble novel oncology approvals in both countries from 2020 through 2025 [s1].

The unit of analysis is the novel approval [s1] — a first approval of a drug, rather than an added indication for one already on the market. That matters for interpreting the counts, because added indications are a large share of oncology regulatory activity in both systems and are excluded here.

The volume

Over the six years, the FDA approved 87 oncology drugs; the NMPA approved 94 [s1].

The trend within that total is the sharper finding. From 2023 to 2025, the NMPA's approval volume increased and exceeded that of the FDA [s1]. The aggregate lead is not evenly distributed across the period — it is the product of a recent divergence.

The speed

On timing, the direction reverses. The FDA reviewed drugs a median of 182 days faster than the NMPA, and approved them a median of 164 days earlier [s1].

Those two figures measure different things. Review time is the regulator's own clock — how long an application sits under assessment. Approval date is when a drug becomes available in a market, which depends on when the sponsor filed as well as how fast the agency moved. A roughly six-month gap on both suggests the difference is mostly in review duration rather than in filing sequence, though the study does not decompose it that way.

The expedited-pathway gap

The two agencies use accelerated mechanisms at very different rates. Eighty-seven percent of FDA oncology approvals in the period came through expedited mechanisms, against 65% of NMPA approvals [s1].

That gap is the most interesting number in the paper, and it cuts in a direction that complicates the speed comparison. The FDA is faster while running nearly nine in ten of its oncology approvals through expedited routes — mechanisms that exist precisely to shorten the path to market. A portion of the median-182-day advantage therefore reflects how heavily one agency leans on those routes, not process efficiency alone.

The study does not evaluate that trade-off, and neither figure tells you whether either agency is calibrated correctly. But a straight reading of "the FDA is faster" without the 87%-versus-65% context misses what is being compared.

First-in-class

The FDA had more global first-in-class approvals over the period [s1].

This is the "volume, not novelty" claim, and this study supports it — with the important qualifier that the study reports the direction without a figure in its abstract, so the size of the gap is not established here. First-in-class status is also a genuinely hard thing to adjudicate across two regulatory systems with different naming, classification and target-designation conventions.

What this is evidence for

Three things, stated at the strength the data support.

That China's regulator has become a high-volume approver of novel oncology drugs, overtaking the FDA on count from 2023 [s1]. That it remains slower per approval, by roughly half a year on both review and approval timing [s1]. And that the FDA retains a lead in first-to-market novel mechanisms [s1].

What it is not evidence for: anything about the clinical quality of what either agency approved. The study counts approvals and measures timing. It does not compare the strength of the evidence packages, the magnitude of clinical benefit, post-market safety records, or patient outcomes in either country. Approval counts are a measure of regulatory throughput, and treating them as a measure of therapeutic progress is the standard error in this genre.

The authors' own framing is modest and forward-looking: as regulatory capacity expands globally, cross-national comparisons help identify approaches that are working and inform regulatory modernisation [s1].

Limits

Both databases are public regulatory records, which makes the counts reproducible but inherits each agency's own classification decisions. What counts as a "novel oncology approval" is defined slightly differently in each system, and any harmonisation involves judgement calls the abstract does not detail. The six-year window also spans the COVID-19 period, which disrupted trial conduct and regulatory operations in both countries unevenly.

What to watch

Whether the NMPA's post-2023 volume lead persists, and whether the review-time gap narrows as capacity expands. Those two trends moving together — more approvals, faster — would be a materially different picture from the one this study describes. The more consequential question sits underneath both, and this paper cannot answer it: whether the drugs in the larger Chinese column are new mechanisms or additional entrants in classes that already exist.

This article is informational and does not constitute medical advice.

Sources

• [s1] Collins G, Pandita D, Andrews H, et al., "A cross-national review of novel oncology approvals in the United States and China (2020-2025)," Health Affairs Scholar, published online 10 July 2026. https://doi.org/10.1093/haschl/qxag183