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Hutchmed's Sovleplenib Wins Orphan Drug Designation in US for Autoimmune Hemolytic Anemia

MT Newswires·11/05/2026 00:12:49
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12:12 AM EST, 11/05/2026 (MT Newswires) -- Hutchmed (China) (HCM.L) secured the orphan drug designation from the US Food and Drug Administration for sovleplenib to treat autoimmune hemolytic anemia. The designation marks the second orphan drug status granted to sovleplenib, following one for primary immune thrombocytopenia in October, the London-listed biopharmaceutical company said Thursday. The status makes Hutchmed eligible for development incentives, including seven years of US market exclusivity upon regulatory approval for the designated indication.