SystImmune, Inc. Subsidiary of Baili Pharmaceutical Receives FDA Approval for SI-B001 (Izalontamab) in Combination with Docetaxel for NSCLC Clinical Trial

On October 9, 2023, Biokin (688506) announced that the U.S. Food and Drug Administration (FDA) had recently approved its investigational new drug application for the clinical trial of SI-B001, an innovative biologic independently developed by the company, in combination with docetaxel.

SI-B001, with the generic name izalontamab, is an EGFR×HER3 bispecific antibody. It is currently the only bispecific antibody targeting both EGFR and HER3 in clinical development worldwide, holding the potential to deliver breakthrough therapeutic efficacy. In China, this investigational drug is undergoing clinical trials across multiple indications, including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma, esophageal cancer, and gastrointestinal tumors. Notably, the clinical trial for NSCLC has advanced to Phase III, with accelerated enrollment of subsequent subjects underway.

According to the announcement, the indication approved for the clinical trial of SI-B001 in combination with docetaxel is non-small cell lung cancer.

Previously, BL-B01D1, another globally first-in-class EGFR x HER3 bispecific antibody-drug conjugate (ADC) independently developed by Biokin and included in its ADC drug pipeline, received FDA Investigational New Drug (IND) approval in July 2023.