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HUTCHMED Announces Sovleplenib Granted US FDA Orphan Drug Designation for Autoimmune Hemolytic Anemia

HCM
  • US FDA granted Orphan Drug Designation to sovleplenib for treating autoimmune hemolytic anemia (AIHA).
  • This is the second Orphan Drug Designation for sovleplenib, following its designation for primary immune thrombocytopenia (ITP) in October 2026.
  • Sovleplenib is a novel, selective, oral spleen tyrosine kinase (Syk) inhibitor developed by HUTCHMED.
  • Orphan Drug Designation eligibility includes 7 years of US market exclusivity upon regulatory approval, tax credits for qualified clinical trials, user fee waivers, & specialized regulatory guidance.
  • New Drug Applications (NDAs) for sovleplenib in primary ITP & warm AIHA are currently under review by China's National Medical Products Administration (NMPA).
  • NMPA reviews are supported by positive data from the pivotal ESLIM-01 trial (ITP) & ESLIM-02 trial (wAIHA).
  • AIHA is an autoimmune disorder characterized by red blood cell destruction, with an estimated prevalence of 17 per 100,000 adults & a death rate of 8-11%.
  • Warm AIHA (wAIHA) accounts for approximately 75-80% of all adult AIHA cases.
  • HUTCHMED retains all worldwide rights to sovleplenib.