IN BRIEF: Hutchmed China's sovleplenib designated orphan drug by FDA
5th Nov 2026 14:34
Hutchmed China Ltd - Hong Kong-based biopharmaceutical company - Says its autoimmune hemolytic anemia medication sovleplenib was granted orphan drug designation by the US Food & Drug Administration. Medications are eligible for orphan drug designation if they treat rare diseases or conditions affecting fewer than 200,000 people in the US and, if approved for commercialisation, can have 7 years of market exclusivity in the US. The FDA already granted sovleplenib this designation in October for primary immune thrombocytopenia. Sovleplenib is an oral drug that inhibits the enzyme called spleen tyrosine kinase. Hutchmed says sovleplenib's new drug application for both uses is pending in China. Read More