Biokin announced on 2 July that its bispecific antibody-drug conjugate (ADC) izalontamab brengitecan (BL-B01D1) met primary endpoints in a late-stage trial for nasopharyngeal carcinoma, marking the world's first Phase III success for a bispecific ADC. The randomised controlled study (n=386) evaluated the molecule against physician's-choice chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients who failed PD-1/PD-L1 inhibitors and ≥2 prior chemotherapy lines. Primary endpoints were objective response rate (ORR) and overall survival (OS).

Izalontamab brengitecan targets EGFR/HER3 with a proprietary camptothecin-derived payload (ED04, drug-to-antibody ratio 8). Phase I data presented in 2023 showed 45.8% ORR and 100% disease control rate (DCR) in 24 patients. Five indications have received China's Breakthrough Therapy Designation (BTD), with 40+ trials ongoing in China and the US.