永泰生物-B(06978.HK)啟動CAR-T-19注射液產品一期臨牀試驗進程
格隆匯 2 月 26日丨永泰生物-B(06978.HK)發佈公吿,有關集團的其中一個管線產品CAR-T-19注射液產品(“CAR-T-19注射液”)獲國家藥品監督管理局藥品審評中心批准進行新藥臨牀試驗(“IND”)申請。獲得IND批准後,公司已啟動CAR-T-19注射液的一期臨牀試驗進程,並於2021年2月25日在北京召開的啟動會議上介紹了一期臨牀試驗方案及建議時間表。會議獲得逾30位專家及專業人士的踴躍出席,包括中國領先的公立及私立醫院(預計將參與一期臨牀試驗)的科室主任及主管醫生、合約研究機構及服務提供商。公司預計將於2021年5月招募首名患者參與一期臨牀試驗,於2022年第一季度完成目標患者招募,並於2022年公佈初步分析及結果。
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