HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application ("NDA") for sovleplenib for the treatment of adult patients with warm antibody autoimmune hemolytic anemia ("wAIHA") who have had an insufficient response to at least one previous glucocorticoid treatment has been accepted for review and granted priority review by the China National Medical Products Administration ("NMPA"). Sovleplenib is a novel, selective, oral inhibitor targeting spleen tyrosine kinase ("Syk"), being developed for the treatment of immune diseases and hematological malignancies.

Autoimmune hemolytic anemia ("AIHA") is an autoimmune disorder characterized by the destruction of red blood cells ("RBCs") due to the production of antibodies against RBC. The incidence of AIHA is estimated to be 0.8-3.0/100,000 adults per year with an estimated prevalence of 17 per 100,000 adults and a death rate of 8-11%.1,2 wAIHA is the most common form of AIHA,3 accounting for about 75-80% of all adult AIHA cases.4

The NDA is supported by data from ESLIM-02, a randomized, double blind, placebo-controlled China Phase II/III study in adult patients with primary or secondary wAIHA who had relapsed or were refractory to at least one prior line of standard treatment. In January 2026, the Phase III part of the trial met its primary endpoint of durable hemoglobin (Hb) response rate within weeks 5 to 24 of treatment. The Phase III results will be presented at the upcoming European Hematology Association (EHA) Congress 2026.

Results from the Phase II part of the study published in The Lancet Haematology in January 2025 demonstrated encouraging hemoglobin benefit compared with placebo, with overall response rate of 43.8% vs 0% in the first 8 weeks, and overall response rate of 66.7% during the 24 weeks of sovleplenib treatment (including patients that crossed over from placebo) with a favorable safety profile.5 Additional details of the study may be found at clinicaltrials.gov, using identifier NCT05535933.

Mr Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, said, "We are pleased to have submitted the NDA for sovleplenib in wAIHA, securing both Priority Review and Breakthrough Therapy Designation from the NMPA. This marks the second indication for which we have submitted an NDA for sovleplenib and underscores its broad potential as a novel oral Syk inhibitor. We look forward to providing this much-needed option for wAIHA patients with few treatment alternatives, while strengthening our hematology portfolio with this valuable new indication."

The NMPA granted Breakthrough Therapy Designation to sovleplenib for the treatment of wAIHA in March 2026, as a potential new treatment for a serious condition for which there are no effective treatment options, and where clinical evidence demonstrates significant advantages over existing therapies.