Core Viewpoint - Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. has submitted a new drug application for its Talizumab injection (GR1802) for the treatment of moderate to severe atopic dermatitis, which has achieved its primary endpoint in Phase III clinical trials [1][2]. Group 1: Drug Information - The drug Talizumab injection (GR1802) is a fully humanized monoclonal antibody targeting IL-4Rα, designed to inhibit Th2-type inflammatory responses by blocking the binding of IL-4 and IL-13 to IL-4Rα [2]. - Talizumab injection is currently undergoing clinical trials for multiple indications, including chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and seasonal allergic rhinitis in adults and adolescents, all in Phase III trials, while asthma is in Phase II, and pediatric/adolescent atopic dermatitis is in Phase Ib/IIa [2]. Group 2: Regulatory Status - As of the announcement date, only two other drugs targeting the same pathway have been approved for marketing in China [3]. - The new drug application has been accepted by the National Medical Products Administration (NMPA) and is currently under review [1].

Core Viewpoint - Zhixiang Jintai (688443.SH) announced that its drug Talizhi Baikan (GR1802 injection) has achieved primary endpoint indicators in a Phase III clinical trial for moderate to severe atopic dermatitis in adults, and the company has submitted a new drug application to the National Medical Products Administration (NMPA) which has been accepted [1] Group 1 - Talizhi Baikan (GR1802 injection) is a fully humanized recombinant anti-IL-4Rα monoclonal antibody developed by the company, targeting IL-4Rα [1] - The drug specifically binds to human IL-4Rα on the cell surface, blocking the binding of IL-4 and IL-13 to IL-4Rα, thereby inhibiting downstream STAT6 phosphorylation and CD23 upregulation, which suppresses Th2-type inflammatory responses mediated by IL-4 or IL-13 [1] Group 2 - Multiple indications for Talizhi Baikan are in clinical trial stages, including chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria in Phase III trials, seasonal allergic rhinitis in both adults and adolescents in Phase III trials, asthma in Phase II trials, and atopic dermatitis in children/adolescents in Ib/IIa trials [1]