On June 25, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported 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 (Press release, Carsgen Therapeutics, JUN 25, 2025, View Source [SID1234654116]). The NDA submission is mainly based on the results of an open-label, multicenter, randomized controlled confirmatory Phase II clinical trial (CT041-ST-01, NCT04581473) conducted in China. The data have been presented in The Lancet and at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
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In addition, the company is actively 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.
Professor Lin Shen from Beijing Cancer Hospital, the principal investigator of the CT041-ST-01 clinical trial, said, "Gastric cancer is a malignancy with a substantial global disease burden and significant treatment challenges. For patients with advanced gastric cancer, in particular, existing therapeutic options and their efficacy remain severely limited, resulting in extremely poor survival outcomes. Within the current treatment landscape for gastric cancer, a growing number of patients have experienced failure with immunotherapy and anti-angiogenic therapies. Treatment choices and potential benefits become even more constrained in the third-line setting and beyond. Consequently, there exists a significant unmet clinical need for advanced gastric cancer patients after second-line treatment failure. The confirmatory randomized controlled clinical trial of satri-cel has clearly demonstrated that, compared with existing standard therapies, satri-cel offers significant advantages and clinical value in extending both progression-free survival (PFS) and overall survival (OS). The trial results have garnered widespread international attention and recognition, providing a solid evidentiary foundation for satri-cel’s New Drug Application (NDA) submission. We look forward to the approval and market launch of satri-cel, which will offer a new treatment option for the broader population of gastric cancer patients."
Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "We are delighted to announce that the NDA for our self-developed Claudin18.2-targeted CAR T-cell product satri-cel has been accepted for review by China’s NMPA. This marks the world’s first CAR T-cell therapy product for solid tumors to reach the NDA stage—a major milestone for the CAR-T field. I extend my sincere gratitude to all clinical investigators, trial coordinators, and patients involved in this program. We are hopeful for its timely approval to provide gastric cancer patients with a new treatment option."
About Satri-cel
Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. Satri-cel targets the treatment of Claudin18.2-positive solid tumors with a primary focus on G/GEJA and pancreatic cancer (PC). Initiated trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced G/GEJA in China (CT041-ST-01, NCT04581473), a Phase Ib registrational trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), an investigator-initiated trial for satri-cel be used as consolidation treatment following adjuvant therapy in patients with resected G/GEJA (CT041-CG4010, NCT06857786), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595).
Satri-cel has been granted Priority Review by the Center for Drug Evaluation (CDE) of China’s NMPA for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in May 2025. Satri-cel has been granted Breakthrough Therapy Designation by the CDE of China’s NMPA for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in March 2025. Satri-cel was granted Regenerative Medicine Advanced Therapy designation by U.S. FDA for the treatment of advanced G/GEJA with Claudin18.2-positive tumors in January 2022. Satri-cel received Orphan Drug designation from the U.S. FDA for the treatment of G/GEJA in September 2020.