ArticleBMC cancer2026
Accelerating cancer therapy review: a cross-sectional analysis of expedited approval in China, 2005-2021.
Article in BMC cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Current clinical applications and future developments of platinum-based anticancer drugs.Journal of biological inorganic chemistry : JBIC : a publication of the Society of Biological Inorganic Chemistry · 2026Review
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Authors and funding
8 authors.
Funding
Abstract
backgroundChina’s Expedited Approval (EA) pathways, launched in 2005, aim to accelerate patient access to novel cancer therapies. Yet the clinical value and regulatory efficiency of oncology drugs approved under EA have not been comprehensively evaluated in a Chinese context or compared against global benchmarks.
methodsWe conducted a cross-sectional analysis of all malignant hematology and oncology drugs granted EA by China’s National Medical Products Administration between 2005 and 2021. Publicly available CDE reports, clinical trial registries, and literature sources were used to extract indication characteristics, review durations, trial design features, and ESMO-MCBS scores. Descriptive statistics summarized drug and trial features. Kruskal-Wallis tests compared median review times across factors; multiregional trial design and clinical benefit associations were explored qualitatively.
resultsNinety-nine drugs were granted expedited approval for 144 indications, 68% were small-molecule agents and 32% biologics; 86% underwent Priority Review, 28% Special Approval, and 24% Conditional Approval. Median review duration declined from over 1 000 days (2014&2016) to ~ 300 days post-2015. Imported drugs (median 289 days) were reviewed faster than domestic ones (401 days). Of 137 pivotal trials supporting new indications, 70% were randomized and 66% parallel-controlled; primary endpoints were ORR (43%) and PFS (37%). Among 86 solid-tumor trials with ESMO-MCBS data, 34% achieved scores indicating meaningful clinical benefit (grades 4–5 or A–B).
conclusionChina’s EA program has markedly accelerated oncology drug approval timelines to levels approaching the EMA, though still trailing the FDA. While most pivotal trials used surrogate endpoints, only one-third of solid-tumor indications demonstrated high clinical benefit per ESMO-MCBS. To balance expedited access with therapeutic value, future reforms should emphasize early benefit assessment, real-world outcomes, and alignment of surrogate endpoints with overall survival benefits.
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