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永泰生物-B(06978.HK)启动CAR-T-19注射液产品一期临床试验进程
格隆汇 02-26 06:16

格隆汇 2 月 26日丨永泰生物-B(06978.HK)发布公告,有关集团的其中一个管线产品CAR-T-19注射液产品(“CAR-T-19注射液”)获国家药品监督管理局药品审评中心批准进行新药临床试验(“IND”)申请。获得IND批准后,公司已启动CAR-T-19注射液的一期临床试验进程,并于2021年2月25日在北京召开的启动会议上介绍了一期临床试验方案及建议时间表。会议获得逾30位专家及专业人士的踊跃出席,包括中国领先的公立及私立医院(预计将参与一期临床试验)的科室主任及主管医生、合约研究机构及服务提供商。公司预计将于2021年5月招募首名患者参与一期临床试验,于2022年第一季度完成目标患者招募,并于2022年公布初步分析及结果。

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