Bio-Thera Solutions Receives NMPA Approval for CTLA-4 and PD-1 Inhibitor Combo Study

China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to initiate a clinical study for its BAT4706, a cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody (mAb), in combination with its programmed death-1 (PD-1) inhibitor BAT1308. The study will focus on the treatment of advanced solid tumors.

BAT1308: Restoring T Cell Immune Function
BAT1308 is an in-house developed PD-1 monoclonal antibody (mAb) that binds to PD-1 on the surface of T cells, relieving the inhibitory effect of the PD-1 pathway and restoring the immune killing function of T cells, thereby inhibiting tumor growth.

BAT4706: Enhancing Anti-Tumor Immunity
BAT4706 is an afucosylation-optimized IgG1 mAb under development specifically targeting CTLA-4, an immune checkpoint expressed on regulatory T cells and activated CD4+ and CD8+ T cells. By binding to CTLA-4, BAT4706 aims to restore T cell activation, enhance antibody-dependent cytotoxicity, and improve the body’s anti-tumor immunity. Studies have demonstrated that CTLA-4 mAb, either as a monotherapy or in combination with other treatments, exhibits promising anti-tumor effects in various solid tumors.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry