HUTCHMED (China) Limited reported that the registration portion of its ESLIM‑02 Phase III trial of sovleplenib, a selective spleen tyrosine kinase (Syk) inhibitor, met its primary endpoint in adult patients with warm‑antibody autoimmune hemolytic anemia (wAIHA) in China. The study demonstrated rapid, durable responses, with a 66.7% overall response rate at 24 weeks and a 43.8% response at 8 weeks, compared with 0% in the control arm.
The positive data reinforce sovleplenib’s therapeutic potential in a disease that affects roughly 17 per 100,000 adults and carries an 8‑11% mortality rate. Current first‑line therapy relies on corticosteroids, and refractory cases often require rituximab, immunosuppressants, or splenectomy. Sovleplenib offers a novel mechanism that targets Fc receptor signaling, potentially improving outcomes for patients who have limited options.
HUTCHMED plans to submit a New Drug Application to China’s National Medical Products Administration in the first half of 2026, positioning the company for regulatory approval and a commercial launch. The company also continues to study sovleplenib in immune thrombocytopenia (ITP), where Phase III results have already been published and an NDA resubmission is scheduled for the same period, broadening the drug’s market opportunity.
Financially, HUTCHMED reported six‑month revenue of $277.7 million for the period ended June 30, 2025, down from $305.7 million a year earlier, but net income surged to $455.0 million from $25.8 million, largely due to a partial disposal of equity in a subsidiary. For full‑year 2024, oncology product revenue reached $271.5 million, up 65%, and the company has guided 2025 consolidated oncology/immunology revenue to $350 million–$450 million, reflecting confidence in its pipeline and the momentum from the wAIHA data.
The trial results are expected to strengthen HUTCHMED’s pipeline and enhance its prospects for future product launches. Management highlighted the significance of the data, noting that the rapid, durable responses in wAIHA patients could address a substantial unmet need and provide a new therapeutic option in a competitive landscape that includes other Syk inhibitors such as fostamatinib and BTK inhibitors like rilzabrutinib.
The announcement underscores HUTCHMED’s strategic focus on oncology and immunology, and the positive Phase III data for sovleplenib represent a key milestone that could accelerate the company’s path to regulatory approval and commercial success.
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