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FDA grants Orphan Drug Designation for HUTCHMED's sovleplenib in autoimmune hemolytic anemia
HCMHUTCHMED (China) Ltd
The US FDA has granted Orphan Drug Designation to HUTCHMED's sovleplenib for the treatment of autoimmune hemolytic anemia (AIHA). This marks the second such designation for sovleplenib, following a prior grant for primary immune thrombocytopenia. The designation provides eligibility for development incentives including seven years of US market exclusivity upon approval, tax credits for qualified clinical trials, and user fee waivers. HUTCHMED is an innovative biopharmaceutical company focused on the discovery and commercialization of targeted therapies and immunotherapies.