CARsgen® U.S. Clinical Holds Lifted by FDA

SHANGHAI,Nov. 1,2024 -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK),a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors,announces that the U.S. Food and Drug Administration ("FDA") lifted the clinical holds on clinical trials of zevorcabtagene autoleucel (zevor-cel,CT053,an autologous CAR-T product against BCMA),satricabtagene autoleucel (satri-cel,CT041,an autologous CAR-T product against Claudin18.2),and CT071 (an autologous CAR-T product against GPRC5D) in the United States.

About CARsgen Therapeutics Holdings Limited

CARsgen is a biopharmaceutical company with operations in China and the U.S.,focusing on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. CARsgen has established a comprehensive CAR T-cell research and development platform that covers target discovery,innovative CAR T-cell development,clinical trials,and commercial-scale production. Internally,CARsgen has developed novel technologies and a product pipeline with global rights to address significant challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile,enhancing the efficacy in treating solid tumors,and reducing treatment costs. CARsgen's mission is to become a global biopharmaceutical leader that provides innovative and differentiated cell therapies for cancer patients worldwide and makes cancer 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.

For more information,please visit https://www.carsgen.com/