China NMPA Grants Priority Review to CARsgen’s Satri-cel for G/GEJA

China NMPA Grants Priority Review to CARsgen’s Satri-cel for G/GEJA

By, Admin 30 May 2025

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.

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