Lepu Biopharma has received China National Medical Products Administration (NMPA) approval for becotatug vedotinas, marking the first global EGFR-targeting antibody-drug conjugate (ADC) approval, in this case for recurrent or metastatic nasopharyngeal cancer (NPC) following failure of at least two systemic chemotherapy lines and PD-1/L1 inhibitor therapy. The candidate utilises a valine-citrulline linker conjugating a monoclonal antibody (mAb) to a MMAE payload, demonstrating 30.2% objective response rate (ORR) versus 11.5% for chemotherapy in a Phase II trial, with median progression-free survival (mPFS) improvement of 5.82 months versus 2.83 months and 37% risk reduction. The approval addresses an unmet need in nasopharyngeal cancer where 89% of advanced cases express EGFR, with limited treatment options after standard therapy failure. Lepu is exploring combination with PD-1 inhibitor pucotenlimab, and expansion into head and neck squamous cell carcinoma indications. PharmCube's NextBiopharm® database identifies four additional EGFR ADCs in clinical development, including candidates from CSPC Pharma, Bliss Biopharma, DAC Biotech and Henlius Biotech.
