RegulatoryApr 29, 2026, 06:02 AM
HCM: China NMPA Accepts Sovleplenib NDA for wAIHA, Grants Priority Review
AI Summary
HUTCHMED announced that China's NMPA accepted its New Drug Application (NDA) for sovleplenib to treat adult patients with warm antibody autoimmune hemolytic anemia (wAIHA), granting it priority review and Breakthrough Therapy Designation. This NDA is supported by positive data from the ESLIM-02 Phase II/III study, which met its primary endpoint in the Phase III part. Sovleplenib, a novel oral Syk inhibitor, is also under NMPA priority review for immune thrombocytopenia (ITP), marking its second indication.
Key Highlights
- HUTCHMED's NDA for sovleplenib in warm antibody autoimmune hemolytic anemia (wAIHA) accepted by China NMPA.
- NMPA granted priority review and Breakthrough Therapy Designation for sovleplenib in wAIHA.
- NDA supported by positive ESLIM-02 Phase III data, meeting primary endpoint of durable hemoglobin response.
- Phase II results showed 43.8% overall response rate vs 0% placebo in 8 weeks.
- Sovleplenib is a novel, selective oral spleen tyrosine kinase (Syk) inhibitor.
- Second NDA for sovleplenib in immune thrombocytopenia (ITP) also accepted for priority review in Feb 2026.
- China has 430,000 existing ITP patients with 41,000 new patients annually.
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