SHANGHAI, July 13, 2025 /PRNewswire/ — CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces a favorable outcome in opposition proceedings before the European Patent Office (EPO) concerning its European patent EP3445407, which covers its GPC3-targeted CAR-T cell therapy.
On July 3, 2025, a U.S.-based biotechnology — the sole appellant among the original two opponents — formally withdrew its appeal against the EPO Opposition Division’s earlier decision to maintain the patent. This withdrawal renders the EPO’s decision final and binding for the opponents, effectively concluding their part in the opposition process.
The patent was granted by the EPO in 2022 and opposed by two parties in 2023. Following oral proceedings, the EPO Opposition Division issued a decision to maintain the patent in amended form, upholding key claims related to the use of GPC3 CAR-T cell therapy following cyclophosphamide and fludarabine lymphodepletion pretreatment, in the treatment of liver cancer, lung cancer, ovarian cancer, breast cancer, gastric cancer, and thyroid cancer. Following the decision, only one opponent filed an appeal within the allowable period. That appeal has now been withdrawn.
Under EPO procedures, the opponents or any other third party can no longer challenge the patent at the EPO. This development further reinforces CARsgen’s intellectual property position in the field of GPC3-targeted CAR-T therapies, a promising and innovative approach for the treatment of solid tumors.
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.
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