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HUTCHMED (China) ( (HK:0013) ) has shared an announcement.
HUTCHMED has secured acceptance and priority review in China for its New Drug Application for sovleplenib to treat adults with warm antibody autoimmune hemolytic anemia who have not responded adequately to prior glucocorticoid therapy. The oral spleen tyrosine kinase inhibitor, which has also received Breakthrough Therapy Designation, is supported by positive Phase II/III data showing durable hemoglobin responses and a favorable safety profile, positioning HUTCHMED to strengthen its hematology portfolio and potentially address a high unmet need in autoimmune blood disorders.
Sovleplenib is already being developed for immune thrombocytopenia, where it has delivered positive Phase III results and a separate priority review NDA in China, and HUTCHMED retains global rights to the asset. The dual late-stage programs in wAIHA and ITP highlight the broad potential of this Syk inhibitor across immune-mediated hematologic diseases and could enhance the company’s competitive footing in China’s fast-growing hematology and immunology market if approvals follow.
More about HUTCHMED (China)
HUTCHMED is an innovative, commercial-stage biopharmaceutical company focused on discovering, developing and commercializing targeted therapies and immunotherapies for cancer and immunological diseases. The group advances drug candidates from in-house discovery to global markets, with three medicines already marketed in China and one also approved in the U.S., Europe and Japan.
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