Bio-Thera Solutions’ PD-1 and ADC Combo Gets NMPA Approval for Clinical Trial in Solid Tumors

Bio-Thera Solutions, Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for a combination therapy of BAT1308 and BAT8006 in patients with advanced solid tumors.

BAT1308 is an in-house developed programmed death-1 (PD-1) monoclonal antibody (mAb) designed to bind to PD-1 on the surface of T cells, relieving the immune inhibitory effect of the PD-1 pathway and thereby restoring and enhancing T cell immune killing function to inhibit tumor growth.

BAT8006 is an antibody-drug conjugate (ADC) consisting of an anti-FRα antibody linked to a topoisomerase I inhibitor payload through a proprietary cleavable linker that is highly stable systemically. FRα, a folic acid-binding protein overexpressed in various solid tumors including ovarian, lung, and breast cancer, is minimally distributed and has lower expression levels in normal human tissues. Preclinical studies have demonstrated that BAT8006 exhibits high anti-tumor activity and can effectively kill both tumors and adjacent cells through a bystander effect.- Flcube.com

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