CARsgen Therapeutics' Satricabtagene Autoleucel Granted Priority Review by China's NMPA for Advanced Gastric Cancer Therapy

Reuters
2025.05.28 04:06
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CARsgen Therapeutics Holdings Ltd. announced that its product, Satricabtagene Autoleucel (Satri-cel), has received priority review from China's National Medical Products Administration (NMPA) for treating Claudin18.2-positive advanced gastric cancer in patients unresponsive to previous therapies. This status aims to expedite the regulatory process, potentially allowing for a quicker market introduction of this innovative CAR T-cell therapy, underscoring CARsgen's dedication to addressing unmet clinical needs.

CARsgen Therapeutics Holdings Ltd. announced that its product, Satricabtagene Autoleucel (Satri-cel), has been granted priority review by China's National Medical Products Administration (NMPA). This decision highlights the potential of Satri-cel in treating Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have not responded to at least two prior lines of therapy. The priority review status aims to expedite the regulatory process, potentially bringing this innovative CAR T-cell therapy to market sooner. The announcement emphasizes CARsgen's commitment to developing advanced cell therapies to meet unmet clinical needs, without indication of any other organizations receiving similar grants or approvals in this announcement.

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