Zhi Tong Cai Jing·2026-02-10 12:44Core Viewpoint - The company, Jiangsu Hengrui Medicine Co., Ltd., has received acceptance for its drug application for SHR-A1811 (注射用瑞康曲妥珠单抗) from the National Medical Products Administration, which has been included in the priority review process [1] Group 1: Drug Application and Clinical Trials - The drug application is based on a randomized, open-label, positive-controlled, multi-center Phase III clinical trial [1] - The trial aims to evaluate the efficacy and safety of SHR-A1811 compared to standard treatment in HER2-positive advanced colorectal cancer patients who have failed previous treatments with oxaliplatin, fluorouracil, and irinotecan [1] - The study is led by Dr. Li Jin from Shanghai Gaobo Cancer Hospital and Professor Yuan Ying from the Second Affiliated Hospital of Zhejiang University School of Medicine, with participation from 40 centers nationwide [1] Group 2: Study Outcomes - The primary endpoint of the study is progression-free survival (PFS) assessed by an independent imaging review committee (IRC) according to RECIST v1.1 [1] - Results indicate that SHR-A1811 significantly extends PFS in HER2-positive advanced colorectal cancer patients compared to standard treatment, reducing the risk of disease progression or death [1] - Overall survival (OS) data shows a trend of benefit, although it is currently only observed [1]