Hutchmed's Sovleplenib Lands Orphan Drug Designation in US for Autoimmune Disorder

01:20 AM EDT, 10/29/2026 (MT Newswires) -- Hutchmed (China) (HCM.L) secured the orphan drug designation from the US Food and Drug Administration for sovleplenib as a treatment for primary immune thrombocytopenia, an autoimmune disorder. The orphan drug status makes the London-listed biopharmaceutical company eligible for development incentives, including seven years of US market exclusivity upon regulatory approval for the designated indication, according to a Thursday release. The oral spleen tyrosine kinase inhibitor is also under regulatory review in China for the same indication and warm antibody autoimmune hemolytic anemia, based on positive data from the respective ESLIM-01 and ESLIM-02 trials.