CARsgen Therapeutics Holdings Limited, a biopharmaceutical company developing innovative CAR T-cell therapies, announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Priority Review to satricabtagene autoleucel (satri-cel, CT041).
The Priority Review designation applies to satri-cel 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.
About Satri-cel (CT041)
Satri-cel is an autologous CAR T-cell product candidate targeting the Claudin18.2 protein, with the potential to become the first-in-class CAR T therapy for Claudin18.2-positive solid tumors.
Indications and Focus Areas
Satri-cel is being developed for:
- Claudin18.2-positive gastric/gastroesophageal junction adenocarcinoma (G/GEJA)
- Pancreatic cancer (PC)
Ongoing Clinical Trials
CARsgen has initiated multiple trials for satri-cel, including:
- CT041-CG4006 (NCT03874897): Investigator-initiated trial
- CT041-ST-01 (NCT04581473): Confirmatory phase II trial for advanced G/GEJA in China
- CT041-ST-05 (NCT05911217): Phase Ib trial for PC adjuvant therapy in China
- CT041-CG4010 (NCT06857786): Investigator-initiated trial using satri-cel as consolidation therapy after adjuvant treatment for resected G/GEJA
- CT041-ST-02 (NCT04404595): Phase 1b/2 trial for advanced gastric or pancreatic adenocarcinoma in North America
Regulatory Milestones
Satri-cel has received multiple regulatory designations, reflecting its potential and urgency:
- Breakthrough Therapy Designation by China’s NMPA in March 2025
- Regenerative Medicine Advanced Therapy (RMAT) Designation by the US FDA in January 2022
- Orphan Drug Designation by the US FDA for G/GEJA in September 2020
About CARsgen Therapeutics
CARsgen Therapeutics is a biopharmaceutical company dedicated to the development of innovative CAR T-cell therapies. Its pipeline addresses unmet clinical needs in areas including:
- Hematologic malignancies
- Solid tumors
- Autoimmune diseases
CARsgen is committed to advancing cutting-edge treatments to improve outcomes for patients with serious and underserved conditions.
