SHANGHAI, China, Oct 13, 2025, CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that the Premarket Approval Application (PMA) for its proprietary Claudin18.2 immunohistochemistry (IHC) assay kit has been accepted by China’s National Medical Products Administration (NMPA). The companion diagnostic kit is designed to identify gastric or gastroesophageal junction adenocarcinoma (G/GEJA) patients eligible for satricabtagene autoleucel (“satri-cel”, CT041) – an autologous CAR T-cell product candidate against protein Claudin18.2. Characterized by high sensitivity and specificity, the assay kit serves as a critical companion diagnostic tool within CARsgen’s Claudin18.2-targeted portfolio.
Over 3000 gastrointestinal tumor samples tested using this kit revealed an approximate 84% Claudin18.2 expression rate in G/GEJA samples, with a positivity rate (2+/3+, ≥40%) of about 67%, while pancreatic cancer samples showed a Claudin18.2 expression rate of approximately 73% and a positivity rate (2+/3+, ≥40%) of around 53%.
The regulatory acceptance of PMA of the assay kit follows the NMPA’s acceptance of satri-cel’s New Drug Application (NDA) in June 2025, demonstrating synchronized co-development and concurrent submissions of an innovative therapy with its companion diagnostic, which is expected to accelerate the delivery of an integrated precision diagnosis and treatment solution to more patients.
About CARsgen Therapeutics Holdings Limited
CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production. CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen’s mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases curable.
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