天壇生物(600161.SH):“注射用重組人凝血因子VIIa”已通過倫理審查、完成臨牀入組前準備等工作
格隆匯8月10日丨天壇生物(600161.SH)公佈,公司所屬成都蓉生藥業有限責任公司研製的“注射用重組人凝血因子VIIa”已通過中國醫學科學院血液病醫院(血液學研究所)醫學倫理委員會臨牀倫理審查、完成臨牀入組前準備等工作,於近日正式開展I期臨牀試驗,現將有關信息披露如下:

上述產品在生產、上市銷售前還需履行的主要程序包括:開展III期臨牀試驗,提交上市許可申請,通過國家藥品監督管理局藥品審評中心審評及國家藥品監督管理局審批後,獲得藥品註冊批件。
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