Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a Chinese pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I study for its investigational biologic product BC001. The study will assess the safety, tolerability, efficacy, and pharmacokinetics of BC001, a monoclonal antibody targeting vascular endothelial growth factor receptor 2 (VEGFR2), when used in combination with PD-1 inhibitors for the treatment of advanced or metastatic solid tumors. This includes, but is not limited to, first-line HER-2 negative advanced or metastatic gastric cancer/adenocarcinoma at the gastroesophageal junction (GC/GEJ) in combination with Tyvyt (sintilimab injection).
BC001, classified as a Category 1 biologic product, is under development for the treatment of gastric cancer, non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and other solid tumors. The monoclonal antibody is designed to specifically bind to VEGFR2, blocking the VEGF signaling pathway and inhibiting angiogenesis, which in turn inhibits tumor growth. This clinical trial approval follows a previous clinical nod for metastatic colorectal cancer (mCRC) received by Buchang Pharmaceuticals in August of the previous year.
The initiation of this Phase I study marks a significant step for Buchang Pharmaceuticals as it continues to expand its pipeline and contribute to the development of innovative cancer treatments.- Flcube.com
