CARsgen U.S. Clinical Holds Lifted by FDA
CARsgen U.S. Clinical Holds Lifted by FDA
SHANGHAI, Oct. 31, 2024 /PRNewswire/ -- 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.
上海，2024年10月31日 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited（股票代码：2171.HK）是一家专注于创新CAR T细胞治疗，用于治疗血液恶性肿瘤和实体瘤的公司，宣布美国食品和药物管理局（"FDA"）解除对zevorcabtagene autoleucel（zevor-cel，CT053，一个针对BCMA的自体CAR-T产品）、satricabtagene autoleucel（satri-cel，CT041，一个针对Claudin18.2的自体CAR-T产品）和CT071（一个针对GPRC5D的自体CAR-T产品）在美国临床试验的临床暂停。
About CARsgen Therapeutics Holdings Limited
关于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.
CARsgen是一家在中国和美国运营的生物制药公司，专注于创新CAR T细胞治疗，用于治疗血液恶性肿瘤和实体瘤。CARsgen建立了一个全面的CAR T细胞研发平台，涵盖靶点发现、创新CAR T细胞开发、临床试验和商业规模生产。在内部，CARsgen开发了新技术和全球权利的产品管道，旨在解决现有CAR T细胞治疗面临的重大挑战。努力的方向包括改善安全性特征、提高治疗实体瘤的有效性和降低治疗成本。CARsgen的使命是成为全球生物制药领导者，为全球癌症患者提供创新和差异化的细胞治疗，使癌症可治愈。
Forward-looking Statements
前瞻性声明
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, . 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.
本新闻稿中所有非历史事实的声明或与当前事实或现状无关的声明均为前瞻性声明。该前瞻性声明表达了集团截止本新闻稿日期对未来事件的当前看法、预测、信念和期望。这些前瞻性声明基于一系列超出集团控制的假设和因素。因此，它们面临重大风险和不确定性，实际事件或结果可能与这些前瞻性声明及本新闻稿中讨论的前瞻性事件有实质性差异。这些风险和不确定性包括但不限于我们最近年度报告和中期报告以及其他公告和报告中详细说明的标题“主要风险和不确定性”下的信息。对于本新闻稿中包含的任何预测、目标、估计或预测的实现或合理性不做任何陈述或保证，且不应依赖于这些内容。
For more information, please visit
欲获取更多信息，请访问。
SOURCE CARsgen Therapeutics
来源 CARsgen Therapeutics