HUTCHMED said the US Food and Drug Administration granted Orphan Drug Designation to sovleplenib for autoimmune hemolytic anemia (AIHA), marking the drug's second US orphan designation after primary immune thrombocytopenia (ITP) in October 2026. Sovleplenib is a selective, once-daily oral spleen tyrosine kinase (Syk) inhibitor. If approved for the designated indication, it would be eligible for seven years of US market exclusivity, tax credits for qualified clinical trials, Prescription Drug User Fee Act waivers and specialized FDA guidance. HUTCHMED said Chinese regulatory authorities are reviewing applications for sovleplenib in primary ITP and warm AIHA, supported by positive data from the pivotal ESLIM-01 and ESLIM-02 trials, respectively.