HUTCHMED (China) Limited announced that China’s National Medical Products Administration has accepted its New Drug Application for sovleplenib to treat adult patients with warm antibody autoimmune hemolytic anemia (wAIHA) who show inadequate response to at least one prior glucocorticoid therapy. The filing has been granted both Priority Review and Breakthrough Therapy Designation, positioning sovleplenib for accelerated assessment.

wAIHA accounts for roughly 75–80% of adult autoimmune hemolytic anemia cases; the overall disorder shows an estimated incidence of 0.80–3.00 per 100,000 adults per year, prevalence of 17.00 per 100,000 adults, and mortality of 8–11%.

The NDA is supported by ESLIM-02, a randomized, double-blind, placebo-controlled Phase II/III trial. The Phase III portion met its primary endpoint of durable hemoglobin response between Weeks 5 and 24; detailed data will be presented at the European Hematology Association Congress 2026. Phase II results published in The Lancet Haematology showed an overall response rate of 43.80% versus 0% for placebo in the first eight weeks and 66.70% across 24 weeks of sovleplenib therapy, alongside a favorable safety profile.

Sovleplenib is a selective oral spleen tyrosine kinase inhibitor designed to interrupt B-cell receptor and Fc-receptor signaling. Beyond wAIHA, the drug is in late-stage development for immune thrombocytopenia (ITP); a resubmitted NDA for ITP also holds Priority Review status following positive Phase III results published earlier. China is estimated to have 0.43 million existing ITP patients with 0.04 million new cases annually. HUTCHMED retains global rights to sovleplenib.

The company describes the NDA as its second submission for sovleplenib and highlights the asset’s potential to reinforce HUTCHMED’s hematology portfolio. Forward-looking statements emphasise regulatory timelines and further clinical development risks.