Hutchmed (HCM) said the US Food and Drug Administration has granted an orphan drug designation to sovleplenib, a treatment for primary immune thrombocytopenia, a bleeding disorder.
In China, the National Medical Products Administration is reviewing Hutchmed's new drug application for sovleplenib in primary immune thrombocytopenia and warn antibody autoimmune hemolytic anemia. The company said the applications are supported by "positive" data from two trials in the country.
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