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].

泰利奇拜单抗注射液(GR1802注射液)是一款由公司自主研发的重组全人源抗IL-4Rα单克隆抗体，作用 靶点为IL-4Rα。泰利奇拜单抗注射液能特异性结合细胞表面人IL-4Rα，阻断IL-4、IL-13与IL-4Rα的结 合，抑制下游STAT6磷酸化，抑制CD23上调，从而抑制由IL-4或IL-13介导的Th2型炎症反应。泰利奇拜 单抗注射液(GR1802注射液)的多个适应症处于临床试验阶段，慢性鼻窦炎伴鼻息肉、慢性自发性荨麻 疹、成人以及青少年季节性过敏性鼻炎适应症处于III期临床试验阶段，哮喘适应症处于II期临床试验阶 段，儿童/青少年特应性皮炎适应症处于Ib/IIa期临床试验阶段。 智翔金泰(688443.SH)发布公告，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。 ...