CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that its chimeric antigen receptor (CAR) T-cell therapy, Satricabtagene autoleucel (CT041), has been awarded Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The targeted indication is Claudin18.2-positive advanced gastric / gastroesophageal junction cancer (G / GEJ) in patients who have failed at least two prior lines of therapy.
Drug Profile
Satri-cel, an autologous CAR T-cell product candidate targeting the protein Claudin18.2, has initiated clinical studies in gastric cancer (GC) / gastroesophageal junction cancer (GEJC) and pancreatic cancer in the US and China. Previously, the drug was granted Regenerative Medicine Advanced Therapy (RMAT) status for use in Claudin18.2 + advanced GC / GEJC by the US FDA in January 2022, after receiving Orphan Drug Designation (ODD) for the treatment of GC / GEJC in September 2020. The therapy is planned for market filing in China during the first half of 2025.-Fineline Info & Tech
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