HUTCHMED's Sovleplenib Wins FDA Orphan Drug Designation for Rare Bleeding Disorder ITP

HUTCHMED (China) Limited (HCM) said the U.S. FDA has granted Orphan Drug Designation to Sovleplenib, an oral Syk inhibitor in development for primary immune thrombocytopenia (ITP), a rare autoimmune disorder that raises bleeding risk. The designation makes the drug eligible for seven years of U.S. market exclusivity if approved for the indication, plus tax credits for eligible trials and FDA fee waivers. HUTCHMED estimates roughly 56,000 people across the U.S., Germany, France, Italy, Spain, the U.K. and Japan live with primary ITP, with about 110,000 in China. The FDA program covers diseases affecting fewer than 200,000 people in the U.S. New drug applications for Sovleplenib are under review by China's NMPA for primary ITP and warm antibody autoimmune hemolytic anemia, backed by data from the pivotal ESLIM-01 and ESLIM-02 trials. HUTCHMED retains worldwide rights. HCM closed Wednesday's trading at $13.32, down 3.48%.