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HIM01 is a recombinant humanized bifunctional fusion protein designed to simultaneously target Programmed Death-Ligand 1 (PD-L1) and Transforming Growth Factor-beta (TGF-β). Developed by Hangzhou Heal-In-Mind Biotechnology, the drug aims to overcome the immunosuppressive tumor microenvironment by blocking the PD-1/PD-L1 checkpoint while neutralizing TGF-β, a cytokine often associated with immune evasion, epithelial-mesenchymal transition (EMT), and fibrosis in tumors. This dual mechanism is intended to enhance anti-tumor immune responses compared to PD-L1 inhibition alone. As of early 2025, HIM01 is undergoing exploratory Phase 1 clinical trials in healthy subjects to evaluate its safety, pharmacokinetics, and immunogenicity.
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