Gelonghui, April 21丨Baili Tianheng (688506.SH) announced that the combination drug “BL-B01D1+PD-1 monoclonal antibody ± chemotherapy” related to the innovative biopharmaceutical injectable BL-B01D1 (EGFR×HER3-ADC) independently developed by the company recently received the “Drug Clinical Trial Approval Notice” officially approved and issued by the National Drug Administration (NMPA).
BL-B01D1 is a globally exclusive dual-antibody ADC drug independently developed by the company that targets EGFR and HER3 at the same time. EGFR and/or HER3 are highly expressed in most epithelial tumors. BL-B01D1 single drug shows strong efficacy signals in multiple epithelial tumor indications, especially in non-small cell lung cancer, small cell lung cancer, nasopharyngeal cancer, esophageal squamous cancer, and breast cancer, and has shown potential breakthrough efficacy in patients. BL-B01D1 monotherapy for the treatment of locally advanced or metastatic nasopharyngeal cancer patients has been included in the list of breakthrough treatment varieties by the Drug Evaluation Center of the State Drug Administration.
Currently, clinical research on BL-B01D1 as a single agent to treat terminal nasopharyngeal cancer and second-line esophageal squamous cell carcinoma has entered phase III research.