Core Viewpoint - The announcement by Kintor Pharmaceutical regarding the clinical trial results of Shu Rui Ji Ao Lun Sai injection (CT041) for advanced gastric and gastroesophageal junction adenocarcinoma has been accepted for oral presentation at the 2025 American Society of Clinical Oncology (ASCO) annual meeting [1] Group 1: Product Overview - Shu Rui Ji Ao Lun Sai injection is a potential first-in-class autologous CAR-T cell therapy targeting Claudin18.2 protein, primarily for treating Claudin18.2 positive solid tumors, including gastric and gastroesophageal junction adenocarcinoma, as well as pancreatic cancer [2] - The ongoing trials include multiple studies in China, such as a confirmatory Phase II trial for advanced gastric/gastroesophageal junction adenocarcinoma (CT041-ST-01) and a Phase I trial for pancreatic cancer (CT041-ST-05) [2] Group 2: Regulatory Designations - In February 2025, Shu Rui Ji Ao Lun Sai injection received breakthrough therapy designation from the National Medical Products Administration of China for advanced gastric/gastroesophageal junction adenocarcinoma that has failed at least two lines of prior treatment [2] - In January 2022, the product was granted "Regenerative Medicine Advanced Therapy" designation by the FDA for treating advanced gastric/gastroesophageal junction adenocarcinoma [2] - In 2020, it was designated as an "orphan drug" by the FDA for the same indications [2]
科济药业-B(02171)：舒瑞基奥仑赛注射液研究结果的摘要已获2025年ASCO年会接受进行口头报告