SynthesisBMC cancer2025
Regulatory and clinical outcomes of priority-reviewed innovative cancer drugs in China between 2015 and 2024: an observational study.
Synthesis in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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.
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Who cites it
2 citing papers in PubMed.
- Price trend, clinical benefit and within-class competition of drugs for metastatic Non-small cell lung cancer in China: a retrospective cohort study.The Lancet regional health. Western Pacific · 2026Article
- Indication Expansion Dynamics and Trial Characteristics of Novel Multi-Indication Anti-Cancer Drugs in China (2000-2024): A Cross-Sectional Study.Drug design, development and therapy · 2026Article
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundChina implemented the Priority Review Program (PRP) to accelerate the approval of innovative drugs with significant clinical value. This study explores whether drugs approved through the PRP have more significant clinical benefits by comparing differences in approval time, efficacy, and safety between drugs approved through the priority and non-priority review pathways.
methodsIn this observational comparative analysis, we conducted an analysis of innovative cancer drugs approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) between January 1, 2015, and December 31, 2024. Data were systematically collected and evaluated on NDA/BLA review times, efficacy outcomes (overall survival [OS], progression-free survival [PFS], and overall response rate [ORR]), and safety outcomes (Grade ≥ 3 adverse events [AEs] and treatment-related serious adverse events [SAEs]). A meta-analysis was conducted to assess the hazard ratios for PFS, ORR, and the risk ratios for Grade ≥ 3 AEs and treatment-related SAEs. Additionally, subgroup analyses were conducted to assess the impact of the 2020 policy changes on the PRP.
resultsThe NMPA approved 49 innovative cancer drugs for 69 indications, of which 47 indications were subject to priority review and 22 to non-priority review. Priority-reviewed indications significantly shortened NDA/BLA review times (263.5 vs. 352 days, p < 0.001). However, no significant differences in efficacy were observed between priority and non-priority-reviewed indications in terms of median PFS (9.87 vs. 8.95 months, p = 0.875), median OS (10.85 vs. 20.85 months, p = 0.240), the hazard ratio of PFS (0.46 vs. 0.50, p = 0.608), and ORR (60.8% vs. 67.6%, p = 0.915; pooled ORR: 54% vs. 53.7%, p = 0.986). In contrast, priority-reviewed indications were associated with higher risks of Grade ≥ 3 AEs (56.33% vs. 57.35%, p = 0.732; risk ratio: 1.68 vs. 1.12, p = 0.017) and treatment-related SAEs (14.46% vs. 24.55%, p = 0.087; risk ratio: 1.82 vs. 1.39, p = 0.021) compared to non-priority-reviewed indications.
conclusionsAlthough the PRP expedites patient access to innovative drugs, evidence remains insufficient to demonstrate significant additional benefits in efficacy and safety.
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