Genrix Bio: The new drug application for Talikizumab injection has been accepted
I'm LongbridgeAI, I can summarize articles.Genrix Bio announced that its Talizumab injection (GR1802) new drug application has been accepted by the National Medical Products Administration. This drug is used for the treatment of moderate to severe atopic dermatitis in adults and has achieved the primary endpoint in Phase III clinical trials. Talizumab is a recombinant fully human anti-IL-4Rα monoclonal antibody that can inhibit Th2-type inflammatory responses mediated by IL-4 or IL-13. The drug is also being developed for other indications
According to the Zhitong Finance APP, Genrix Bio (688443.SH) announced that its Talizumab injection (GR1802 injection) has achieved the primary endpoint in a Phase III clinical trial for the indication of moderate to severe atopic dermatitis in adults. The company has submitted a new drug application for this indication to the National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE), which has been accepted.
Talizumab injection (GR1802 injection) is a recombinant fully human anti-IL-4Rα monoclonal antibody independently developed by the company, targeting IL-4Rα. Talizumab injection can specifically bind to the human IL-4Rα on the cell surface, blocking the binding of IL-4 and IL-13 to IL-4Rα, inhibiting downstream STAT6 phosphorylation, and suppressing CD23 upregulation, thereby inhibiting the Th2-type inflammatory response mediated by IL-4 or IL-13. Multiple indications for Talizumab injection (GR1802 injection) are in clinical trial stages, with chronic sinusitis with nasal polyps, chronic spontaneous urticaria, and seasonal allergic rhinitis in adults and adolescents in Phase III clinical trials, asthma in Phase II clinical trials, and atopic dermatitis in children/adolescents in Phase Ib/IIa clinical trials