China-based Guilin Sanjin Pharmaceutical Co. Ltd (SHE: 002275) announced that its subsidiary, Dragon Boat Pharmaceutical (Shanghai) Co., Ltd, has received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I clinical study of BC007, a bispecific antibody (BsAb) targeting CLDN18.2 and CD47, in patients with solid tumors.
Drug Profile
BC007 is designed with differential affinity for its two targets. The high affinity for CLDN18.2 enables specific binding to tumor cells expressing this antigen, while the lower affinity for CD47 enhances safety. The drug blocks the CD47/SIRPα signaling pathway, releasing CD47-mediated immunosuppression in tumors. No similar product is currently available globally.
Clinical Trial Details
The Phase I study will assess the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor efficacy of BC007 in solid tumor patients. The trial marks a key step in Dragon Boat’s efforts to develop innovative cancer therapies.-Fineline Info & Tech
