HUTCHMED’s sovleplenib hits primary goal in Phase III anemia trial

HUTCHMED (China) Limited (NASDAQ:HCM) shares climbed in after-hours trading Wednesday after the company announced that its novel Syk inhibitor, sovleplenib, met the primary endpoint in the Phase III registration portion of the ESLIM-02 trial.

The study, conducted in China, focused on adult patients with warm antibody autoimmune hemolytic anemia (wAIHA), a rare and potentially life-threatening blood disorder where the immune system destroys its own red blood cells.

The trial demonstrated a statistically significant durable hemoglobin response between weeks 5 and 24 compared to a placebo.

This success is a major milestone for patients who have relapsed or become refractory to standard treatments like corticosteroids, which currently offer few long-term solutions.

wAIHA accounts for approximately 80% of all adult autoimmune hemolytic anemia cases and carries a mortality rate as high as 11%.

HUTCHMED plans to submit a New Drug Application (NDA) to China’s National Medical Products Administration (NMPA) in the first half of 2026.

The company is concurrently preparing a resubmission for sovleplenib in immune thrombocytopenia (ITP) for the same period.

With full ESLIM-02 results slated for presentation at an upcoming scientific congress, HUTCHMED retains all global rights to the drug as it moves toward its first potential commercial approvals.