HUTCHMED (China) Limited (NASDAQ:HCM) on Tuesday shared data from the Phase 3 registration part of the ESLIM-02 clinical trial of sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia (wAIHA).
wAIHA is a condition where the immune system mistakenly makes IgG antibodies that attack and destroy red blood cells at normal body temperature, leading to anemia, fatigue, paleness, and shortness of breath.
The trial conducted in China met its primary endpoint of durable hemoglobin (Hb) response rate within weeks 5 to 24 of treatment.
The incidence of AIHA is estimated to be 0.8-3.0/100,000 adults per year, with an estimated prevalence of 17 per 100,000 adults and a death rate of 8-11%.
wAIHA is the most common form of AIHA, accounting for about 75-80% of all adult AIHA cases.
ESLIM-02 is a China-based Phase 2/3 study in adult patients with primary or secondary wAIHA who had relapsed or were refractory to at least one prior line of standard treatment.
Results from the Phase 2 part of the study were published in The Lancet Haematology in January 2025.
The study demonstrated hemoglobin benefit compared with placebo, with an overall response rate of 43.8% vs 0% in the first 8 weeks, and an overall response rate of 66.7% during the 24 weeks of sovleplenib treatment (including patients that crossed over from placebo) with a favorable safety profile.
HUTCHMED plans to submit the New Drug Application for sovleplenib for wAIHA to the China National Medical Products Administration (NMPA) in the first half of 2026.
In addition to wAIHA, sovleplenib is also being studied in immune thrombocytopenia (ITP). An NDA resubmission for sovleplenib for second-line ITP is planned in the first half of 2026.
Competition
In December 2025, Novartis AG (NYSE:NVS) shared results from the VAYHIT2 Phase 3 trial of ianalumab plus eltrombopag in ITP patients previously treated with corticosteroids.
The median time to treatment failure for patients receiving ianalumab plus eltrombopag was 2.8 times longer than those on placebo plus eltrombopag (13.0 months vs. 4.7 months).
Also in December 2025, CRISPR Therapeutics AG (NASDAQ:CRSP) said it initiated a Phase 1 trial of its allogeneic CAR T therapy in ITP and wAIHA.
Other Drug Update
On Monday, HUTCHMED initiated the Phase 3 part of the Phase 2/3 trial of the combination of surufatinib, camrelizumab, nab-paclitaxel, and gemcitabine as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma in China.
HCM Price Action: HUTCHMED (China) shares were up 5.09% at $14.45 during premarket trading on Wednesday, according to Benzinga Pro data.
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