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HUTCHMED Announces NDA Acceptance in China with Priority Review Status and Breakthrough Designation for Sovleplenib for the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., April 29, 2026 (GLOBE NEWSWIRE) -- 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 Adminis
About this update from Hutchmed (china) Limited
[{"type":"image","alt":"HUTCHMED (China) Limited","displaySize":"","headline":null,"caption":"HUTCHMED (China) Limited","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":92,"url":"https://media.zenfs.com/en/globenewswire.com/96f02f9f1009ccc284c00f92693f0df0"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/ZJVE1lCMKkq0VyPhjqtrPg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTEyOQ--/https://media.zenfs.com/en/globenewswire.com/96f02f9f1009ccc284c00f92693f0df0","width":300,"height":92}},"lazy":false},{"type":"text","content":"HONG KONG and SHANGHAI and FLORHAM PARK, N.J., April 29, 2026 (GLOBE NEWSWIRE) -- 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.","length":699,"tagName":"p"},{"type":"text","content":"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","length":423,"tagName":"p"},{"type":"text","content":"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.","length":515,"tagName":"p"},{"type":"text","content":"Results from the Phase II part...