Chongqing Genrix Biopharmaceutical Co.,Ltd. (688443.SH): New Drug Application for Taleqibamab Injection Accepted for Review

Stock News09-11

Chongqing Genrix Biopharmaceutical Co.,Ltd. (688443.SH) announced that its Taleqibamab injection (GR1802 injection) for moderate to severe atopic dermatitis in adults has recently achieved its primary endpoint in Phase III clinical trials. The company has submitted a new drug application for this indication to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) and has received acceptance for review.

Taleqibamab injection (GR1802 injection) is a proprietary recombinant fully human anti-IL-4Rα monoclonal antibody developed by the company, with IL-4Rα as its target. The injection specifically binds to human IL-4Rα on cell surfaces, blocking the binding of IL-4 and IL-13 to IL-4Rα, inhibiting downstream STAT6 phosphorylation, and suppressing CD23 upregulation, thereby inhibiting Th2-type inflammatory responses mediated by IL-4 or IL-13.

Multiple indications for Taleqibamab injection (GR1802 injection) are currently in clinical trial stages. Chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and seasonal allergic rhinitis in adults and adolescents are in Phase III clinical trials. The asthma indication is in Phase II clinical trials, while the pediatric/adolescent atopic dermatitis indication is in Phase Ib/IIa clinical trials.

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