On 15 July 2025, China's Biokin Pharma launched a Phase II study evaluating the efficacy and safety of its bispecific ADC BL-B01D1 (izalontamab brengitecan) combined with Keytruda (pembrolizumab) with or without bevacizumab for recurrent/metastatic cervical and endometrial cancers. BL-B01D1, the first EGFR×HER3 bispecific ADC to reach Phase III trials, has shown promising activity in non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and other solid tumours, with a 69% objective response rate (ORR) in EGFR non-classical mutant NSCLC.

On 2 July 2025, Biokin announced BL-B01D1 met the primary endpoint in a Phase III nasopharyngeal cancer trial. The drug has received breakthrough therapy designations (BTD) in China for five indications, including PD-1/platinum-resistant nasopharyngeal carcinoma and EGFR-TKI-failed NSCLC. This marks its first Phase II trial targeting gynaecological cancers.

According to PharmCube's NextBiopharm database, BL-B01D1 is leading the EGFR×HER3 bispecific ADC race as the only late-stage candidate among 15 competitors. Click here to request a free trial for NextBiopharm.