Novel Hepatocellular Carcinoma Tx receives orphan drug status by FDA

Release Date: 11-Dec-2016

U.S Food and Drug Administration (FDA) have granted orphan drug designation to Yisheng Biopharma’s leading candidate, hepatocellular carcinoma treatment, YSON-001. The drug is complex in nature with multi-component structure of broad immune-modulating 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 down regulating regulatory T cells.  The treatment is clinical biological product or immune-modulating technology derived from Yisheng Biopharmaceutical Company.


Orphan Drug designation is granted to those medications or therapy that are rare, more specifically, affect less than 200,000 patients in the country. These rare diseases are incurable and severe in nature and may cause death. To fulfill the need of treat options for individuals, FDA grants orphan drug designation to drugs which are investigated to be helpful in the treatment of such rare diseases. Orphan drug status is a package of several financial benefits for the drugs and its manufacturers such as certain tax credits and exemption from paying prescription drug user fees normally required from companies submitting products for approval.


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