智翔金泰(688443.SH)：泰利奇拜单抗注射液成人季节性过敏性鼻炎适应症上市申请获得受理

Core Viewpoint - The company, Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd., has achieved the primary endpoint in the Phase III clinical trial for its drug, Talizhi monoclonal antibody injection (GR1802), for the treatment of adult seasonal allergic rhinitis, and has submitted a new drug application to the National Medical Products Administration (NMPA) which has been accepted [1][2]. Group 1 - Talizhi monoclonal antibody injection (GR1802) is a fully human recombinant anti-IL-4Rα monoclonal antibody that specifically binds to human IL-4Rα on cell surfaces, blocking the binding of IL-4 and IL-13, thereby inhibiting the Th2 inflammatory response mediated by these cytokines [1]. - The drug has also received acceptance for a new drug application for the indication of moderate to severe atopic dermatitis in adults, which was submitted in September 2025 [1]. - Multiple other indications are in various stages of clinical trials, including chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria in Phase III, asthma in Phase II, and pediatric/adolescent atopic dermatitis in Phase Ib/IIa [1]. Group 2 - As of the announcement date, there are only two other drugs targeting the same mechanism that have been approved for marketing in China [2].