Kelun-Biotech has secured a third approval from China's National Medical Products Administration (NMPA) for TROP2 antibody-drug conjugate (ADC) sacituzumab tirumotecan in EGFR-mutant non-small cell lung cancer (NSCLC) following progression on tyrosine kinase inhibitor (TKI) therapy. The approval is based on Phase III OptiTROP-Lung04 trial, which showed significant progression-free survival (PFS) improvement versus pemetrexed-platinum chemotherapy with favourable safety profile. The asset features novel linker technology with 7.4 drug-to-antibody ratio (DAR) delivering a belotecan-derived topoisomerase I inhibitor payload with bystander effect potential.

Sacituzumab tirumotecan initially gained a November 2024 approval for triple-negative breast cancer (TNBC) and a March 2025 approval for non-squamous NSCLC post-chemotherapy progression. The ADC demonstrates broad utility across solid tumours including gastric cancer and gynaecological malignancies through TROP2 targeting overexpression in epithelial cancers. Kelun's partnership with MSD enhances global development capabilities, with potential to address significant unmet needs in TKI-resistant lung cancer populations through a novel mechanism to overcome resistance pathways.

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