HUTCHMED (China) Limited (HCM), a commercial-stage biopharmaceutical company, announced on Friday results from the Phase III portion of the ESLIM-02 study of Sovleplenib in patients with warm antibody autoimmune hemolytic anaemia (wAIHA).
The results were presented on June 11, 2026, during the European Haematology Association Congress in Stockholm, Sweden.
Sovleplenib and wAIHA
Sovleplenib is an investigational, selective small molecule inhibitor for oral administration targeting Syk. Syk is a major component in B-cell receptor and Fc receptor signalling and is an established target for the treatment of multiple subtypes of B-cell lymphomas and autoimmune disorders.
In addition to wAIHA, Sovleplenib is also being studied in immune thrombocytopenia.
In wAIHA, the immune system mistakenly thinks these healthy red blood cells are dangerous and attacks them. As a result, the cells are destroyed faster than the body can replace them, causing anaemia. (Source-PMC)
According to the business research company's website, wAIHA reached $0.6 billion market size in 2025 and is expected to grow to $0.93 billion in 2030 at a compound annual growth rate (CAGR) of 9.2%.
Trial Details
ESLIM-02 is a randomised, double blind, placebo-controlled China Phase II/III study in adult patients with primary or secondary wAIHA who had relapsed or were refractory to at least one prior line of standard treatment.
In Phase III part of the study, 90 patients were randomised 1:1 to receive either Sovleplenib (n=44) or placebo (n=46) at a dose of 300 mg once daily for 24 weeks.
Key Findings
-The study met its primary endpoint, with sovleplenib demonstrating a significantly higher durable response rate of 66% versus 15% for placebo during Weeks 5-24.
-During the 24-week double-blind treatment period, Sovleplenib demonstrated the overall response rate defined as haemoglobin (Hb) greater than or equal to 100 g/L with an increase of 20 g/L or more from baseline without rescue therapy.70% of patients in the Sovleplenib arm met the response rate criteria, compared with 22% in the placebo arm.
-The use of protocol-defined rescue therapy was significantly reduced with sovleplenib to 16% vs 54% with placebo.
-Median time to response was 3.1 weeks for Sovapleneib versus 6.3 weeks for placebo, while the median cumulative duration of response among overall responders was 16.1 versus 6.1 weeks, respectively. Safety and Adverse Events
Sovleplenib demonstrated a favourable safety profile according to the firm. Grade 3 and above treatment-emergent adverse events or TEAE were 43% of patients in the Sovleplenib arm and 59% of patients in the placebo arm.
There were no TEAE-related deaths or treatment discontinuations reported in the Sovleplenib group, according to the company.
HCM has traded between $10.40 and $19.50 over the last year. The stock closed Thursday's trade at $10.68, down 1.75%.
In the overnight market, HCM is up 2.81% at $10.98.
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Business News
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.