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李氏大藥廠(00950.HK)旗下新藥獲突破性療法認定 用於治療複發性或轉移性宮頸癌
格隆匯 02-09 22:35

格隆匯 2 月 9日丨李氏大藥廠(00950.HK)宣佈,於2021年2月5日,集團附屬公司中國腫瘤醫療有限公司("COF")用於治療複發性或轉移性宮頸癌的抗PD-L1單克隆抗體Socazolimab(前稱ZKAB001)獲得中國國家藥品監督管理局突破性療法認定。

國家藥監局的上級機構國家市場監督管理總局發佈新修訂藥品註冊管理辦法,由2020年7月1日起生效。新修訂辦法授權多個監管途徑:優先審評審批(包括突破性治療藥物)、附條件批准及特別審批程序。新修訂辦法將優先審評範圍擴大至用於防治嚴重影響生存質量或者嚴重危及生命的疾病,且尚無有效防治手段或者與現有治療手段相比有足夠證據表明具有明顯臨牀優勢的突破性治療藥物。獲得國家藥監局突破性療法認定的藥品於提交新藥申請時可被視為獲得附條件批准及優先審評。

Socazolimab複發性或轉移性宮頸癌單藥療法的臨牀研究由吳令英主任醫師出任牽頭研究者,分兩個階段進行,首先是傳統的開放標記3+3劑量遞增階段,然後是擴展階段。監於臨牀進展至今進度理想,預期將於該年度第二季向國家藥監局提出附條件批准的新藥申請。

Socazolimab為獲Sorrento Therapeutics, Inc("Sorrento")授權於中華人民共和國、香港、澳門及台灣生產的引進藥品。

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