SHANGHAI, China, November 19, 2025, CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that its self-developed Claudin18.2 immunohistochemistry (IHC) assay kit has been officially included in the Priority Evaluation and Approval procedure by the China 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.
According to the “Medical Device Priority Evaluation and Approval Procedure,” a priority evaluation and approval channel is established for eligible domestic and international medical device registration applications, aiming to address clinical needs for medical devices and provide benefits to patients at the earlier opportunity. The priority evaluation and approval designation for CARsgen's Claudin18.2 IHC assay Kit is based on the grounds that it has been recognized as a "clinically urgent medical device for which no product of the same variety has been approved for registration in China." It is expected to become the first Class III in vitro diagnostic reagent targeting Claudin18.2 in China.
In the future, this kit is expected to synergize with innovative therapies targeting Claudin18.2, collectively advancing the progress of precision diagnosis and treatment for solid tumors like gastric cancer, maximizing the clinical value of innovative therapies, and improving patient survival outcomes.
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.
Forward-looking Statements
All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group’s current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group’s control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading “Principal Risks and Uncertainties” in our most recent annual report and interim report and other announcements and reports made available on our corporate website, https://www.carsgen.com. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release.
Contact CARsgen
For more information, please visit https://www.carsgen.com/
Public Relations: PR@carsgen.com
Investor Relations: IR@carsgen.com