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Golidocitinib Capsules Approved with Conditions for Marketing by China NMPA

CCFDIE| Updated: 2025-02-19

     

Recently, the Category 1 innovative drug Golidocitinib capsule (trade name:高瑞哲) of Dizal (Jiangsu) Pharmaceuticals Co. Ltd. is approved with condition for marketing through the priority review and approval procedure by China NMPA. This drug is indicated as a single agent for adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) who have received at least one line of systemic treatment.

As a JAK1 inhibitor, Golidocitinib inhibits tumor cell proliferation by blocking the Janus kinase/signal transducer and activator of transcription (JAK/STAT) protein pathway and inhibiting STAT3 phosphorylation and corresponding signaling in tumor cells. The marketing of this drug provides a new treatment option for adult patients with r/r PTCL.