Sovleplenib shows strong efficacy in wAIHA Phase III trial
HUTCHMED (China) Limited announced positive Phase III results for sovleplenib in wAIHA, demonstrating rapid hemoglobin response and a favorable safety profile with fewer Grade ≥3 adverse events than placebo. The ESLIM-02 study met its primary endpoint, showing significantly higher durable and overall response rates, along with reduced rescue therapy use. The NMPA has accepted the New Drug Application for priority review.
*this image is generated using AI for illustrative purposes only.
HUTCHMED (China) Limited announced that sovleplenib demonstrated rapid and durable hemoglobin response with a favorable safety profile in the Phase III ESLIM-02 study for warm antibody autoimmune hemolytic anemia (wAIHA). The data, presented at the European Hematology Association Congress in Stockholm on June 11, 2026, highlights the drug's potential to address unmet needs in a treatment landscape lacking approved targeted therapies.
The China National Medical Products Administration (NMPA) accepted a New Drug Application for sovleplenib for review and granted it priority review in April 2026. The NMPA had previously granted Breakthrough Therapy Designation to sovleplenib for wAIHA in March 2026.
ESLIM-02 Study Design and Results
ESLIM-02 is a randomized, double-blind, placebo-controlled Phase II/III study conducted in China. It enrolled adult patients with primary or secondary wAIHA who had relapsed or were refractory to at least one prior line of standard treatment. In the Phase III part, 90 patients were randomized 1:1 to receive either sovleplenib 300 mg (n=44) or placebo (n=46) once daily for 24 weeks.
The study met its primary endpoint, showing a significantly higher durable response rate during weeks 5–24 for the sovleplenib arm compared to placebo.
| Metric | Sovleplenib | Placebo | P-value |
|---|---|---|---|
| Durable response rate | 66% | 15% | <0.0001 |
| Overall response rate | 70% | 22% | <0.0001 |
| Rescue therapy use | 16% | 54% | 0.0001 |
| Red blood cell transfusion | 11% | 43% | N/A |
| Glucocorticoid tapering/discontinuation | 50% | 15% | 0.003 |
Sovleplenib achieved a median time to response of 3.1 weeks versus 6.3 weeks for placebo. The median cumulative duration of response among overall responders was 16.1 weeks for sovleplenib compared to 6.1 weeks for placebo. Improvements in hemolytic markers were also observed, indicating alleviation of active hemolysis.
Safety and Subgroup Analysis
Sovleplenib demonstrated a favorable safety profile, with Grade ≥3 treatment-emergent adverse events (TEAE) reported in 43% of patients in the sovleplenib arm versus 59% in the placebo arm. The most common Grade ≥3 TEAEs were warm autoimmune hemolytic anemia (18% vs 43%) and upper respiratory tract infection (2% vs 11%). There were no TEAE-related deaths or treatment discontinuations in the sovleplenib group.
Efficacy findings remained consistent across sensitivity and subgroup analyses. Notably, in patients who had received prior rituximab therapy, the durable response rate was 69% for sovleplenib versus 16% for placebo (p=0.0022).
What is the anticipated timeline for the NMPA's final approval decision following the priority review designation?
Does HUTCHMED plan to file for regulatory approval in other major markets, such as the US or Europe, based on these results?
How will sovleplenib be positioned against current standard-of-care treatments, particularly rituximab, given the high response rates in rituximab-experienced patients?
15
Create Custom Screeners 
Access 200+ Pre-built Filters 
Use 50+ Readymade Screener 
