Shots:
- The Chinese NMPA has accepted NDA & granted priority review to HUTCHMED‘s sovleplenib for the treatment of adults with warm antibody autoimmune hemolytic anemia (wAIHA) who had an inadequate response to ≥1 previous glucocorticoid treatment
- NDA was supported by the Chinese P-II/III (ESLIM-02) assessing sovleplenib vs PBO in adults with primary or secondary wAIHA who had relapsed or were refractory to ≥1L of prior standard treatment
- P-III part met its 1EP of durable hemoglobin response within wks. 5 to 24 in Jan 2026; data will be presented at EHA’26, while the P-II portion showed ORR of 43.8% vs 0% at 8wks. & 66.7% over 24wks., with data published in The Lancet Haematology
Ref: Globenewswire | Image: HUTCHMED | Press Release
Related News: HUTCHMED Initiates P-III Trial of HMPL-760 + R-GemOx for R/R Diffuse Large B-cell Lymphoma in China
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