China’s NMPA Grants Priority Review and Breakthrough Therapy Designation to HUTCHMED’s Sovleplenib for wAIHA Treatment

HUTCHMED has announced that China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for sovleplenib, a treatment for warm antibody autoimmune hemolytic anemia (wAIHA). The application has been granted both Priority Review status and Breakthrough Therapy Designation. These designations aim to expedite the review process for treatments addressing serious or life-threatening conditions with unmet medical needs.

The NDA submission is based on data from clinical trials evaluating the safety and efficacy of sovleplenib in patients with wAIHA, a rare autoimmune disorder where the immune system attacks red blood cells, leading to anemia. The Priority Review status indicates that the NMPA will assess the application more quickly than standard timelines, while the Breakthrough Therapy Designation highlights preliminary evidence suggesting significant advantages over existing treatments. HUTCHMED’s announcement marks a step forward in advancing potential therapeutic options for individuals affected by this condition.

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Date: April 29, 2026

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GOAI