CARsgen Therapeutics Holdings Ltd., a company specializing in innovative CAR T-cell therapies, has announced significant regulatory advancements for its product satricabtagene autoleucel, known as "satri-cel." The Center for Drug Evaluation $(CDE)$ of China's National Medical Products Administration (NMPA) has granted satri-cel Breakthrough Therapy Designation and Priority Review for treating Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma in patients who have failed at least two previous lines of therapy. CARsgen is set to submit a New Drug Application (NDA) to the NMPA this month, with anticipation of approval as the first commercially available CAR-T product for solid tumors globally. This development marks a major milestone in the field, offering new hope for patients with limited treatment options.
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