FDA Grants Orphan Drug Status to Novel Hepatocellular Carcinoma Tx

The orphan drug designation would entitle Yisheng to a seven-year marketing exclusivity in the U.S.
The orphan drug designation would entitle Yisheng to a seven-year marketing exclusivity in the U.S.

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. 

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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.

For more information visit Yishengbio.com.

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