FDA Grants Orphan Drug Status to Novel Hepatocellular Carcinoma Tx
Yisheng Biopharma has announced that the Food and Drug Administration (FDA) has granted orphan drug designation for its candidate hepatocellular carcinoma treatment, YS-ON-001.
YS-ON-001 is a multi-component complex with broad immunomodulating properties such as promoting Th1-biased immunity, inducing the activation and proliferation of dendritic cell, B and natural killer cells, promoting macrophage M1 polarization and downregulating regulatory T cells.
The novel treatment is a clinical stage biological product and is derived from Yisheng's in-house proprietary immunomodulating cell technology. In animal studies it demonstrated excellent anti-tumor efficacy against breast, lung, liver and other cancers as compared to first-line chemotherapies or targeted therapies.
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