Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced that its bispecific antibody drug conjugate (ADC), BL-B01D1, has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) in China. The designation is for the treatment of patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who have failed prior PD-1/PD-L1 monoclonal antibody combined with platinum-based chemotherapy.
BL-B01D1, which targets EGFR and HER3, was the subject of an $8.4 billion licensing deal with US pharmaceutical giant Bristol-Myers Squibb, signed at the end of 2023. The deal involved an upfront payment of $800 million. Prior to this, the molecule had received three BTD statuses in China for the treatment of: previously treated recurrent or metastatic nasopharyngeal carcinoma patients (in April 2024), previously treated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) patients with EGFR sensitive mutations (September 2024), and previously treated locally advanced or metastatic EGFR wild-type NSCLC patients (September 2024). – Flcube.com
