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YS-ON-001 is a first-in-class immuno-oncology biologic product developed by Yisheng Biopharma. It is a multi-component therapeutic consisting of a protein complex and the PIKA immunomodulating agent. The drug is designed to modulate the tumor microenvironment by activating the TLR3, RIG-I, and MDA5 pathways, thereby reducing immunosuppressive effects and enhancing antitumor immune responses. Its broad immunomodulating properties include promoting Th1-biased immunity, activating dendritic cells, B cells, and natural killer (NK) cells, promoting M1 macrophage polarization, downregulating regulatory T cells, and increasing CD4+ and CD8+ T-cell responses. YS-ON-001 is being developed for the treatment of various advanced solid tumors, including hepatocellular carcinoma, breast cancer, and pancreatic cancer, and has received Orphan Drug Designation from the U.S. FDA for both hepatocellular carcinoma and pancreatic cancer.
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