HUTCHMED Sovleplenib Phase III wAIHA Study Meets Primary Endpoint
HUTCHMED announced positive Phase III results from its ESLIM-02 study of sovleplenib for warm antibody autoimmune hemolytic anemia (wAIHA) in China. The study met its primary endpoint, showing a significantly higher durable response rate of 66% compared to 15% for placebo. The drug also demonstrated superior efficacy in overall response rate, reduction in rescue therapy, and a favorable safety profile. Following these results, the New Drug Application for sovleplenib for wAIHA has been accepted for priority review by China's NMPA, which previously granted it Breakthrough Therapy Designation. Additionally, a resubmitted NDA for sovleplenib in immune thrombocytopenia (ITP) was also granted priority review in February 2026.
Key Highlights
- Sovleplenib Phase III ESLIM-02 study met primary endpoint for wAIHA.
- Durable response rate was 66% for sovleplenib vs 15% for placebo (p<0.0001).
- Overall response rate was 70% for sovleplenib vs 22% for placebo (p<0.0001).
- Rescue therapy use significantly reduced to 16% vs 54% for placebo (p=0.0001).
- NMPA accepted NDA for wAIHA with priority review in April 2026.
- NMPA granted Breakthrough Therapy Designation for wAIHA in March 2026.
- Resubmitted NDA for ITP also accepted for priority review in February 2026.
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