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Orphan Drug Designation for YS-ON-001 Treatment

doi: 10.1097/01.COT.0000511604.82641.99
FDA Updates
FDA; YS-ON-001

FDA; YS-ON-001

The FDA has granted Orphan Drug Designation to YS-ON-001 for the treatment of hepatocellular carcinoma. YS-ON-001 is a promising biological product with immunomodulating effects, including induction of anti-tumor cytokines, activation of NK cells, regulation of macrophage polarization, and suppression of regulatory T cells.

YS-ON-001demonstrates efficacy in animal studies against multiple solid tumors, such as breast, lung, liver, and other cancers. Toxicology studies in animals also demonstrated good safety of the product. A multi-component complex with broad immunomodulating properties, YS-ON-001 promotes Th1-biased immunity; induces the activation and proliferation of dendritic cell, B, and natural killer cells; and promotes macrophage M1 polarization and downregulating regulatory T cells.

Orphan Drug Designation is granted to novel drugs and biologics that are defined as those intended for the safe and effective treatment, diagnosis, or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S.

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