CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a China-based company involved in developing innovative CAR T-cell therapies, announced on Wednesday that the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for satricabtagene autoleucel (satri-cel, CT041), an autologous CAR T-cell product candidate against protein Claudin18.2, for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy.

The NDA submission is mainly based on the results of an open-label, multicentre, randomised controlled confirmatory Phase II clinical trial conducted in China. The data have been presented in The Lancet and at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

CARsgen is also expanding satri-cel application in early-line treatment and perioperative treatment of cancer, including an ongoing Phase Ib registrational trial for pancreatic cancer adjuvant treatment and an ongoing investigator-initiated trial for consolidation treatment following adjuvant therapy in patients with resected G/GEJA.

Satri-cel has the potential to be the first-in-class globally. It was granted Regenerative Medicine Advanced Therapy designation by the US FDA for the treatment of advanced G/GEJA with Claudin18.2-positive tumours in January 2022. Satri-cel received Orphan Drug designation from the US FDA for the treatment of G/GEJA in September 2020.