Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- May 4
- 1 min read
29/04/2026
Hutchmed announced NDA acceptance in China with Priority Review status and Breakthrough Designation for sovleplenib for the treatment of wAIHA (Ref)
Hutchmed announced that the New Drug Application (NDA) for sovleplenib (a spleen tyrosine kinase) for the treatment of adult patients with warm antibody autoimmune hemolytic anemia (wAIHA) who had an insufficient response to at least one previous glucocorticoid treatment had been accepted for review and granted priority review by the China National Medical Products Administration.
The NDA was supported by data from the Phase2/3, ESLIM-02/ NCT05535933 study in adult patients with primary or secondary wAIHA who had relapsed or were refractory to at least one prior line of standard treatment.
