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. 2025 Aug 22;16:1593. doi: 10.1007/s12672-025-03282-9

Table 2.

CAR-T development strategy comparison: China vs. Western countries

Dimension China Western countries
Key Targets CD19, BCMA, GPC3, Claudin18.2 CD19, BCMA, HER2, PSMA
Cost (Per Treatment) $150,000 $400,000
Regulatory Pathway Conditional approval + real-world evidence FDA accelerated approval (RMAT/BPR)
Payment Model 1 + 3 + N multi-tier system Outcome-based payment + commercial insurance
Manufacturing Process Localized supply chain, optimized automation Bioreactors like Novartis Prodigy system
Insurance Coverage Regional pilots (e.g., Shanghai “Hu Hui Bao” covers 50%) Primarily covered by private insurance, some government programs
Indication Expansion Focused on solid tumors (e.g., GPC3 for HCC, Claudin18.2 for gastric cancer) Mainly hematologic malignancies, limited solid tumor trials (HER2, PSMA)
Clinical Trials Real-world evidence included in regulatory approval, shorter trial cycles Large-scale RCTs, longer approval cycles