HUTCHMED (00013.HK): Sovleplenib Wins FDA Orphan Drug Status for AIHA

NewTimeSpace News: HUTCHMED (China) Limited (stock code: 00013) announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to sovleplenib for the treatment of autoimmune hemolytic anemia (AIHA). Sovleplenib is a novel, selective, oral spleen tyrosine kinase (Syk) inhibitor.

This marks the second Orphan Drug Designation granted by the FDA for sovleplenib, following the designation for primary immune thrombocytopenia announced in October 2026. The FDA's Orphan Drug Designation programme applies to drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. If approved for the designated indication, designated drugs are eligible for seven years of US market exclusivity from approval, tax credits for qualified clinical trials, user fee waivers under the Prescription Drug User Fee Act, and specialised regulatory guidance from the FDA during clinical development.

In China, New Drug Applications for sovleplenib in primary immune thrombocytopenia and warm AIHA are under review by the National Medical Products Administration, supported by positive data from the pivotal ESLIM-01 and ESLIM-02 trials respectively. Warm AIHA is the most common form of the disease, accounting for about 75% to 80% of all adult AIHA cases. HUTCHMED currently retains all rights to sovleplenib worldwide.