FDA grants second orphan drug designation to Hutchmed's sovleplenib, this time for AIHA

HUTCHMED (China) Limited announced on November 5, 2026 that the US Food and Drug Administration has granted Orphan Drug Designation to sovleplenib for the treatment of autoimmune hemolytic anemia.¹ Sovleplenib is a novel, selective, oral spleen tyrosine kinase inhibitor.¹

This is the second Orphan Drug Designation granted by the FDA for sovleplenib, following the designation for primary immune thrombocytopenia announced in October 2026.¹ That earlier designation, announced October 29, 2026, covered primary immune thrombocytopenia, an autoimmune disorder that can lead to increased risk of bleeding.²

The FDA's Orphan Drug Designation program applies orphan status to drugs and biologics meant to safely and effectively treat, diagnose, or prevent rare diseases or conditions affecting fewer than 200,000 people in the United States.¹ Drugs that win approval under this designation can become eligible for seven years of US market exclusivity, tax credits for qualifying clinical trials, waivers of certain prescription drug user fees, and specialized regulatory guidance from the FDA during development.¹

The company also noted ongoing regulatory activity in China. New Drug Applications for sovleplenib in primary ITP and warm AIHA are currently under review by China's National Medical Products Administration, supported by positive data from the pivotal ESLIM-01 and ESLIM-02 trials conducted in China.¹

HUTCHMED currently retains all rights to sovleplenib worldwide.¹

HUTCHMED describes itself as an innovative, commercial-stage biopharmaceutical company focused on discovery and global development and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases.¹ The company said it has brought drug candidates from in-house discovery to patients worldwide, with its first four medicines marketed in China, the first of which is also approved in markets including the US, Europe and Japan.¹