Hong Kong–listed CARsgen Therapeutics (CARsgen) has received National Medical Products Administration (NMPA) approval for its autologous humanized Claudin18.2 chimeric antigen receptor T-cell (CAR T) therapy, satricabtagene autoleucel (satri-cel). The green light covers treatment of Claudin18.2-positive, HER2-negative, advanced gastric or gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior systemic regimens.
Satri-cel is the first CAR T therapy globally to be authorised for any solid tumour. The product uses a humanised Claudin18.2-specific single-chain fragment (hu8E5-2I) linked to CD8α, CD28 and CD3ζ signaling domains. To enhance tumour infiltration and anti-tumour activity in solid cancers, CARsgen developed a patent-protected lymphodepletion protocol that adds low-dose nab-paclitaxel to cyclophosphamide and fludarabine.
Regulatory approval is based on data from the open-label, multi-centre, randomised Phase II study CT041-ST-01 (NCT04581473) conducted in China. Results, previously presented at the 2025 ASCO Annual Meeting and published in The Lancet, showed “encouraging efficacy” and a “favourable safety profile,” according to the announcement. Specific outcome metrics were not disclosed in the filing.
China recorded an estimated 358,700 new gastric cancer cases in 2022 and incidence is projected to climb to 607,000 by 2050, underscoring a significant addressable patient base for satri-cel.
Pipeline expansion continues: satri-cel is being evaluated in Phase I for pancreatic cancer adjuvant therapy (NCT05911217) and in investigator-initiated trials (IITs) for both perioperative consolidation after resection (NCT06857786) and sequential therapy following first-line treatment for G/GEJA (NCT07179484).
CARsgen retains global patents covering target, indication, dosage and preparative regimen for satri-cel and maintains end-to-end CAR T capabilities, from target discovery through commercial-scale production. A cautionary statement in the announcement notes that successful development or commercialisation is not guaranteed.
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