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PM8001 is a novel bifunctional fusion protein designed to target both programmed cell death ligand 1 (PD-L1) and transforming growth factor beta (TGF-β). Developed by Biotheus, it acts as an immunotherapy agent by simultaneously blocking PD-L1/PD-1-mediated immune checkpoint signals and neutralizing TGF-β in the tumor microenvironment. This dual mechanism aims to enhance anti-tumor immune responses and overcome resistance mechanisms associated with advanced solid tumors. The molecule is smaller than conventional antibodies (~110 kDa), potentially improving tumor penetration, and its Fc region has been engineered to reduce off-target effects. Clinical studies have shown that PM8001 is safe, well tolerated, and demonstrates promising anti-tumor activity in patients with advanced solid tumors—including those previously treated with checkpoint inhibitors[2][3][5][6][9].
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