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.
2024年10月31日上海訊 / 全球新聞發佈/ CARsgen Therapeutics Holdings Limited（股票代碼：2171.HK）公司專注於創新CAR T細胞療法，用於治療血液惡性腫瘤和實體瘤，宣佈美國食品和藥物管理局（"FDA"）解除了對採爾卡特BoNTA基因自體淋巴細胞（採爾卡細胞，CT053，自體BCMA CAR T產品），薩替卡特BoNTA基因自體淋巴細胞（薩替細胞，CT041，自體Claudin18.2 CAR T產品），以及CT071（自體GPRC5D CAR T產品）在美國臨床試驗的臨床暫停。
About CARsgen Therapeutics Holdings Limited
關於CARsgen Therapeutics Holdings Limited CARsgen是一家在中國和美國擁有業務的生物製藥公司，專注於治療血液惡性腫瘤和實體瘤的創新CAR T細胞療法。CARsgen建立了一個全面的CAR T細胞研發平台，包括靶點發現、創新CAR T細胞研發、臨床試驗和商業化大規模生產。CARsgen擁有自主開發的新技術和產品線，具備解決CAR T細胞療法的主要挑戰，如提高安全性、增強治療固體腫瘤的療效和降低治療成本的全球權利。CARsgen的使命是成爲一個全球性的生物製藥領導者，爲全球癌症患者帶來創新和差異化的細胞治療，使癌症變得可治癒。
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是一家在中國和美國開展業務的生物製藥公司，專注於創新的CAR T細胞療法用於治療血液腫瘤和實體腫瘤。CARsgen建立了一個全面的CAR T細胞研發平台，涵蓋目標發現、創新CAR T細胞研發、臨床試驗和商業規模生產。CARsgen內部開發了新技術和產品管線，並擁有全球權利，以應對現有CAR T細胞療法面臨的重大挑戰。努力包括改善安全性、增強治療實體腫瘤的療效和降低治療成本。CARsgen的使命是成爲全球領先的生物製藥公司，爲全球癌症患者提供創新和差異化的細胞療法，並使癌症可治癒。
Forward-looking Statements
前瞻性聲明
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.
本新聞稿中所有非歷史性事實或與目前事實或現狀無關的陳述均爲前瞻性陳述。此類前瞻性陳述表達了集團截至本新聞稿發佈日期對未來事件的當前觀點、預測、信念和期望。此類前瞻性陳述基於集團無法控制的一系列假設和因素。因此，它們面臨重大風險和不確定性，並且實際事件或結果可能與這些前瞻性陳述和本新聞稿中討論的前瞻性事件有重大差異。此類風險和不確定性包括但不限於咱們最近的年度報告和中期報告以及其他公佈在咱們公司網站上的公告和報告訪問。不提供關於本新聞稿中包含的任何預測、目標、估計或預測的實現或合理性，並且不應在這些預測、目標、估計或預測中放置任何依賴。
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SOURCE CARsgen Therapeutics
CARsgen Therapeutics。
