Conditional Approval of Golidocitinib Capsules for Marketing by NMPA

Update: 06 Feb,2026 Source: Haiou Health Views: 112

On June 24, 2024, the National Medical Products Administration (NMPA) conditionally approved the marketing of Golidocitinib Capsules (trade name: Gaoruizhe), a Class 1 innovative drug developed by Dizal (Jiangsu) Pharmaceutical Co., Ltd., through the priority review and approval procedure. This drug is indicated as monotherapy for adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) who have received at least one prior line of systemic therapy.

Golidocitinib is a Janus kinase 1 (JAK1) inhibitor. It exerts an anti-tumor effect by blocking the JAK/STAT (Janus Kinase/Signal Transducer and Activator of Transcription) pathway, which in turn inhibits STAT3 phosphorylation and the corresponding signal transduction in tumor cells, thereby suppressing tumor cell proliferation. The marketing of this drug provides a new treatment option for adult patients with peripheral T-cell lymphoma.

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