HUTCHMED's Sovleplenib Receives US FDA Orphan Drug Designation for Primary Immune Thrombocytopenia

• HUTCHMED's sovleplenib received FDA orphan drug designation for primary immune thrombocytopenia, potentially providing seven years of US market exclusivity upon approval.
• The once-daily oral Syk inhibitor also qualifies for clinical trial tax credits, fee waivers and specialized FDA guidance.
• Chinese applications for primary immune thrombocytopenia and warm antibody autoimmune hemolytic anemia remain under review, supported by positive pivotal trial results.
• ESLIM-01 supported the thrombocytopenia application; ESLIM-02 supported the anemia application.

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