HutchMed’s Sovleplenib Set for Priority Review in China for Chronic Immune Thrombocytopenia

China’s Center for Drug Evaluation (CDE) has indicated that HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) is on track to receive priority review status for its investigational drug, sovleplenib. This designation is granted due to the drug’s potential to treat adults with primary chronic immune thrombocytopenia (ITP) who are unresponsive or have relapsed after first-line treatments, including glucocorticoids and immunoglobulins.

Sovleplenib is a novel, selective oral inhibitor that targets spleen tyrosine kinase (Syk), and is being developed for the treatment of hematological malignancies and autoimmune diseases. Syk plays a critical role in B-cell receptor and Fc receptor (FcR) signaling, making it a key target for therapies addressing various B-cell lymphomas and autoimmune conditions like ITP. The National Medical Products Administration of China granted sovleplenib breakthrough therapy designation for this indication in January 2022.- Flcube.com

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