恒瑞医药(01276.HK):子公司“注射用SHR-1826”纳入突破性治疗品种名单
Ge Long Hui·2026-01-12 14:55

Group 1 - Core viewpoint: Jiangsu Hengrui Medicine Co., Ltd.'s subsidiary, Suzhou Hengrui Medicine Co., Ltd., has had its injectable SHR-1826 included in the list of breakthrough therapeutic varieties by the National Medical Products Administration [1] - Drug name: Injectable SHR-1826, with acceptance number CXSL2300466, classified as a Class 1 therapeutic biological product [1] - Proposed indication: Monotherapy for locally advanced or metastatic non-squamous non-small cell lung cancer with c-Met overexpression (2-3+, ≥50%) in patients who have failed at least one line of systemic treatment [1] Group 2 - Application date: December 1, 2025, for the registration of SHR-1826 [1] - Reason for inclusion: The application meets the requirements of the "Drug Registration Management Measures" and the announcement regarding the "Breakthrough Therapeutic Drug Review Procedures" [1]