On June 22, the NMPA announced the approval of CARsgen’s Satricabtagene autoleucel for the treatment of CLDN18.2-positive, HER2-negative advanced gastric/gastroesophageal junction adenocarcinoma in patients who have failed at least two prior lines of therapy.
This approval marks a significant breakthrough, as it is the world’s first approved CAR-T therapy for solid tumors. Previously approved CAR-T therapies have all been for hematologic malignancies.
Satricabtagene autoleucel (development code: CT041) is a first-in-class autologous humanized CAR-T cell product targeting Claudin18.2. Claudin18.2 is a tumor-associated antigen that is highly expressed in a variety of solid tumors but has limited expression in normal tissues, making it an ideal therapeutic target.
The approval is supported by the CT041-ST-01 Phase II study, the first randomized controlled trial for a CAR-T therapy in solid tumors. The study demonstrated a significant progression-free survival (PFS) benefit with satri-cel compared to standard treatment (median PFS: 3.25 vs. 1.77 months; HR=0.37, p<0.0001), with a median overall survival (OS) of 7.92 months.
With this approval, CAR-T becomes the second drug class to succeed with the CLDN18.2 target, following monoclonal antibodies. The drug, branded as Kailimei, has been priced at RMB 990,000 per patient.
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