By Fineline Cube 
China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for satricabtagene autoleucel (satri-cel, CT041). This autologous CAR T-cell product targets protein Claudin18.2 and is intended for patients with Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) who have failed at least two prior lines of therapy.
Clinical Trial Results
The NDA is based on the CT041-ST-01 study, a pivotal Phase II clinical trial conducted in China. The trial enrolled HER2-negative, Claudin18.2-high expressing advanced G/GEJA patients who had progressed after at least two lines of standard therapy. Results demonstrated significant improvements in progression-free survival (PFS), objective response rate (ORR), and overall survival (OS). These findings were published in The Lancet and presented at the 2025 ASCO Annual Meeting.
Regulatory Recognition
CT041 has received Priority Review and Breakthrough Therapy Designation from China’s Center for Drug Evaluation (CDE). The U.S. FDA has also granted it Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation.