格隆汇2月26日丨智翔金泰(688443.SH)公布，近日，重庆智翔金泰生物制药股份有限公司的泰利奇拜单 抗注射液(GR1802 注射液)用于成人季节性过敏性鼻炎适应症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。 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)的成人中、重度特应性皮炎适应症的新药上市申请已于2025年9月 获受理，另有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、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。 截至本公告披露日 ...

泰利奇拜单抗注射液(GR1802 注射液)的成人中、重度特应性皮炎适应症的新药上市申请已于2025年9月 获受理，另有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、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。 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。 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。 格隆汇2月26日丨智翔金泰(688443.SH)公布，近日，重庆智翔金泰生物制药股份有限公司的泰利奇拜单 抗注射液(GR1802 注射液)用于成人季节性过敏性鼻炎适应症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 ...

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]