The Transformation of Oncology Drug Development in China: Toward a New Phase of Innovation

China’s oncology drug development ecosystem has shifted from rapid pipeline expansion toward clinical value–driven innovation. We review regulatory reform and the 2015 to 2025 evolution of clinical development across small molecules, mAbs, multispecific antibodies, antibody–drug conjugates, and cell and gene therapies. China’s disease burden and enrollment capacity have enabled globally relevant advances in EGFR-mutant lung cancer, gastrointestinal malignancies, hepatocellular carcinoma, nasopharyngeal carcinoma, and CLDN18.2-directed therapies. We highlight persistent challenges in target and modality convergence, biomarker definition, therapeutic window optimization, manufacturing consistency, and globally interpretable evidence generation and discuss how artificial intelligence may connect target discovery, drug design, and clinical trial optimization more efficiently. Significance: China has become a major source of oncology trials and modality innovation, but scale alone will not ensure global impact. This review links regulatory reform, disease-specific opportunity, target biology, therapeutic format, and evidence quality across a decade of solid tumor development. It defines the conditions under which China-originated programs can generate globally practice-changing evidence. See related article by Shi, p. XX .