HUTCHMED (China) Ltd. (HCM) on Wednesday announced that Phase III registration part of its ESLIM-02 clinical trial of sovleplenib in adult patients with warm antibody autoimmune hemolytic anaemia in China has met the primary endpoint.
ESLIM-02 is a randomized, double blind, placebo-controlled China Phase II/III study in adult patients with primary or secondary warm antibody autoimmune hemolytic anaemia (wAIHA) who had relapsed or were refractory to at least one prior line of standard treatment.
The primary endpoint of the study was the durable haemoglobin response rate within weeks 5 to 24 of treatment. Full results of the ESLIM-02 study will be submitted for presentation at an upcoming scientific conference.
In addition, 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 January 2025, Phase II part of the study demonstrated encouraging haemoglobin 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 with a favourable safety profile.
HCM closed Tuesday's trade 2.84% higher at $13.75. In overnight trading, the stock was up 12.51% at $15.47.
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