喜讯连连!科济生物再获CD19靶向的CAR-T细胞的临床试验许可

2019-03-02 不详 美通社

CAR-T细胞免疫疗法研发企业科济生物医药(上海)有限公司(CARsgen Therapeutics)今日宣布:公司在研产品— CT032 人源化CD19自体CAR T细胞注射液用于治疗复发/难治非霍奇金淋巴瘤的临床试验申请已通过了国家药品监督管理局药品审评中心的默示许可。CT032 CAR-CD19 T是由科济生物自主研发的创新药物,采用人源化靶向CD19的嵌合抗原受体(CAR)修饰的T细胞,主

CAR-T细胞免疫疗法研发企业科济生物医药(上海)有限公司(CARsgen Therapeutics)今日宣布:公司在研产品— CT032 人源化CD19自体CAR T细胞注射液用于治疗复发/难治非霍奇金淋巴瘤临床试验申请已通过了国家药品监督管理局药品审评中心的默示许可。


CT032 CAR-CD19 T是由科济生物自主研发的创新药物,采用人源化靶向CD19的嵌合抗原受体(CAR)修饰的T细胞,主要目标适应症为复发/难治非霍奇金B细胞淋巴瘤。此次临床试验获批,是继2019年1月24日针对GPC3靶点的CAR T用于治疗实体瘤的新药临床试验申请获得批准,以及2月27日针对BCMA靶点的CAR T用于治疗多发性骨髓瘤临床试验获得批准之后,科济公司获得的第三个新药临床试验批准的品种。

科济生物董事长、首席执行官兼首席科学官李宗海博士表示:“恶性淋巴瘤是血液系统较常见的恶性肿瘤,GLOBOCAN报告显示[1],2018年全球有超过50万例新增非霍奇金淋巴瘤(NHL)患者,有近25万人死亡。我们希望自主研发的人源化CD19 CAR-T细胞能够为复发/难治的NHL患者带来长期治愈的机会,造福患者。我们将不遗余力地继续开发新颖、安全和有效的细胞免疫疗法,早日实现‘治愈肿瘤’的愿望。”

参考文献:

[1] GLOBOCAN 2018: Estimated Cancer Incidence Mortality and Prevalence Worldwide in 2018. http://gco.iarc.fr/today/fact-sheets-populations  

关于科济生物

科济生物医药(上海)有限公司,是一家致力于开发创新型CAR-T 细胞等药物,以为肿瘤患者提供治疗甚至治愈手段为使命的医药企业。公司已经开发了多个CAR-T细胞候选药物,曾和中国著名医院及医生合作了多项CAR-T细胞治疗肝癌、癌、胰腺癌、多发性骨髓瘤、淋巴瘤、白血病肺癌等的探索性临床研究。

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    2019-08-31 仁心济世
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    2019-03-04 dingxiaobo
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    2019-03-04 smartxiuxiu

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北京时间2018年12月4日上午,科济生物在美国圣地亚哥举行的第60届美国血液学会年会(ASH)公布了编号为CT053的CAR-BCMA-T细胞治疗复发/难治多发性骨髓瘤的安全性和有效性临床研究初步结果。北京时间2018年12月4日上午,科济生物在美国圣地亚哥举行的第60届美国血液学会年会(ASH)公布了编号为CT053的CAR-BCMA-T细胞治疗复发/难治多发性骨髓瘤的安全性和有效性临床研究初