China's Centre for Drug Evaluation (CDE) has granted priority review to Biokin Pharmaceutical's bispecific antibody-drug conjugate (ADC) izalontamab brengitecan for recurrent or metastatic nasopharyngeal carcinoma after PD-1 inhibitor and platinum chemotherapy failure. The designation follows positive Phase III results showing superiority over physician's choice chemotherapy in the 386-patient BL-B01D1-303 trial. Izalontamab brengitecan demonstrated 45.8% objective response rate (ORR) and 100% disease control rate (DCR) in Phase I data.

The first-in-class EGFR/HER3 targeting ADC delivers a proprietary camptothecin derivative ED04 with drug-antibody ratio (DAR) of 8. Bristol-Myers Squibb (BMS) secured ex-China rights in a USD 8.4 billion deal in December 2023. Izalontamab holds five breakthrough therapy designations (BTD) in China covering nasopharyngeal carcinoma, non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma and small cell lung cancer (SCLC).

According to PharmCube's NextBiopharm® database, Bioking and BMS compete with 14 other companies developing EGFR/HER3 ADCs. Click here to request a free trial for NextBiopharm®.