CARsgen’s CT0596 Received IND Clearance from the NMPA for the Treatment of Patients with Relapsed/Refractory Multiple Myeloma

SHANGHAI, China, August 4, 2026, CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that CT0596, an allogeneic CAR T-cell product targeting BCMA, has achieved Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) for the treatment of patients with relapsed/refractory multiple myeloma (R/R MM). The research results of the investigator-initiated trials of CT0596 have been presented as the poster presentation at the 2026 Annual Congress of the European Hematology Association. About CT0596 CT0596 is an allogeneic BCMA-targeted CAR T-cell therapy developed using CARsgen’s proprietary THANK-u Plus® platform. It is currently being evaluated in investigator-initiated trials for R/R MM or plasma cell leukemia (PCL). CT0596 demonstrated preliminary favorable tolerability and encouraging efficacy signals. Further investigation is planned in additional plasma cell malignancies and autoimmune diseases mediated by autoreactive plasma cells. 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 CAR sgen For more information, please visit https://www.carsgen.com/ Public Relations: [email protected] Investor Relations: [email protected] Previous Next

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