澤璟製藥(688266.SH):遞交注射用重組人促甲狀腺激素生物製品上市許可申請
格隆匯6月3日丨澤璟製藥(688266.SH)公佈,公司自主研發的注射用重組人促甲狀腺激素(rhTSH)向國家藥品監督管理局(NMPA)遞交了生物製品上市許可申請(BLA),目前等待正式受理中。本次遞交新藥上市申請的適應症是用於既往接受過甲狀腺切除術的分化型甲狀腺癌患者隨訪時的放射性碘(131I)全身顯像(WBS)檢查和血清甲狀腺球蛋白(Tg)檢測。截至目前,國內尚未有重組人促甲狀腺激素獲批用於該項適應症。
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