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].

人民财讯9月11日电，智翔金泰(688443)9月11日晚间公告，近日，公司的泰利奇拜单抗注射液(GR1802 注射液)用于成人中、重度特应性皮炎适应症III期临床试验达到了主要终点指标，公司向国家药品监督 管理局(NMPA)药品审评中心(CDE)提交了该适应症的新药上市申请并获得受理。截至本公告披露日， 泰利奇拜单抗注射液(GR1802注射液)同靶点药物仅有两款在国内获批上市。 ...