China-based Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical study for its BL-M07D1. The randomized, controlled trial will assess BL-M07D1 versus trastuzumab emtansine as a postoperative adjuvant treatment for HER2-positive breast cancer patients with invasive cancer residues after neoadjuvant treatment.
Significant Anti-Tumor Effects
BL-M07D1, an antibody-drug conjugate (ADC) targeting HER2, has demonstrated significant anti-tumor effects in clinical trials. The drug, which has best-in-class potential, is currently under investigation in nine clinical studies in the US and China. These studies focus on various solid tumors with HER2 expression or mutation, including non-small cell lung cancer, breast cancer, urothelial cancer, gynecological tumors, and gastrointestinal tumors, either as monotherapy or in combination with other drugs.
Future Development and Clinical Trials
With the NMPA’s approval, Biokin Pharmaceutical is poised to advance the clinical development of BL-M07D1. The Phase III study will provide critical data on the drug’s efficacy and safety, potentially offering a new treatment option for patients with HER2-positive breast cancer.-Fineline Info & Tech
