澤璟製藥(688266.SH)擬啟動rhTSHⅢ期臨牀試驗
格隆匯3月1日丨澤璟製藥(688266.SH)公佈,公司根據注射用重組人促甲狀腺激素(以下簡稱“rhTSH”)的Ⅰ/Ⅱ期臨牀試驗研究結果,向國家藥品監督管理局藥品審評中心遞交了兩項Ⅲ期臨牀研究方案“重組人促甲狀腺激素(rhTSH)用於分化型甲狀腺癌患者術後輔助放射性碘清甲治療的有效性和安全性的隨機、開放、多中心、平行對照的Ⅲ期臨牀研究”方案(方案號:ZGTSH003)以及“重組人促甲狀腺激素(rhTSH)用於分化型甲狀腺癌患者術後輔助診斷的有效性和安全性的Ⅲ期臨牀研究”方案(方案號:ZGTSH004)並獲得同意,公司將於近日啟動rhTSH的Ⅲ期臨牀試驗。
本次啟動rhTSH用於分化型甲狀腺癌術後輔助放射性碘清甲治療及術後輔助診斷的兩項Ⅲ期臨牀試驗事項對公司近期業績不會產生重大影響。
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