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) announced that its drug Talichibai Injection (GR1802) has met the primary endpoint in a Phase III clinical trial for moderate to severe atopic dermatitis in adults, and the new drug application has been accepted by the National Medical Products Administration (NMPA) [1] Group 1 - The Phase III clinical trial for Talichibai Injection (GR1802) achieved its primary endpoint [1] - The company has submitted a new drug application for the indication to the NMPA, which has been accepted [1] - As of the announcement date, only two other drugs targeting the same indication have been approved for marketing in China [1]