Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for its investigational injectable product BC001. The product is intended for use in first and second-line metastatic colorectal cancer (mCRC) patients who have experienced treatment failure or intolerance with standard therapy, to be used in combination with trifluridine + tipiracil. Previously, the bureau had cleared BC001 for study in gastric cancer/adenocarcinoma at the gastroesophageal junction (GC/GEJ).
BC001: A Monoclonal Antibody Targeting VEGFR2
The Category 1 biologic product, BC001, is a monoclonal antibody that targets vascular endothelial growth factor receptor 2 (VEGFR2). It is under development for the treatment of gastric cancer, non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and other solid tumors. BC001’s mechanism of action involves specifically binding to VEGFR2, blocking the VEGF signaling pathway, and inhibiting angiogenesis, which in turn inhibits tumor growth.
Potential Impact on Cancer Treatment
The acceptance of BC001 for review by the NMPA marks a significant step in the advancement of this potential treatment option for various solid tumors. If approved, BC001 could offer a new therapeutic approach for patients with mCRC and other cancers, potentially improving treatment outcomes and patient quality of life.-Fineline Info & Tech
