Core Viewpoint - The company Kogei Pharmaceutical-B (02171.HK) announced that its CAR-T cell therapy candidate, Shurijiaolun Sai Injection (CT041), has been prioritized for review by the National Medical Products Administration for treating Claudin18.2 positive advanced gastric/esophagogastric junction adenocarcinoma patients who have failed at least two lines of treatment [1][2]. Group 1 - Shurijiaolun Sai Injection is a potentially first-in-class CAR-T cell therapy targeting Claudin18.2 protein, primarily for advanced gastric/esophagogastric junction adenocarcinoma and pancreatic cancer [2]. - Ongoing clinical trials include a researcher-initiated trial in China (CT041-CG4006, NCT03874897), a confirmatory Phase II trial for advanced gastric/esophagogastric junction adenocarcinoma (CT041-ST-01, NCT04581473), a Phase Ib trial for pancreatic cancer (CT041-ST-05, NCT05911217), and a post-operative consolidation therapy trial (CT041-CG4010, NCT06857786) [2]. - In March 2025, the injection received breakthrough therapy designation from the National Medical Products Administration in China for treating Claudin18.2 positive advanced gastric/esophagogastric junction adenocarcinoma after at least two lines of treatment failure [2]. Group 2 - In January 2022, the injection was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA in the United States for treating Claudin18.2 positive advanced gastric/esophagogastric junction adenocarcinoma [2]. - In September 2020, the injection received Orphan Drug designation from the FDA for treating gastric/esophagogastric junction adenocarcinoma [2].
科济药业-B(02171.HK)：舒瑞基奥仑赛注射液获国家药品监督管理局纳入优先审评