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李氏大藥廠(00950.HK):宮頸癌新藥Socazolimab上市申請獲CDE批准
格隆匯 09-27 23:01

格隆匯9月27日丨李氏大藥廠(00950.HK)宣佈,於2021年9月26日,公司附屬公司中國腫瘤醫療有限公司已獲中國國家藥品監督管理局("國家藥監局")藥品審評中心("藥審中心")批准,就使用抗PD-L1單克隆抗體Socazolimab(前稱ZKAB001)治療複發性或轉移性宮頸癌(已於2021年2月8日獲得突破性療法認定)提交新藥上市申請("新藥申請")。

Socazolimab為針對腫瘤PD-L1蛋白的全人抗PD-L1單克隆抗體,可以釋放由腫瘤細胞引起的免疫系統"剎車"。Socazolimab複發性及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,首先是開放標記3+3劑量遞增階段,然後是關鍵擴展階段研究。合共91名患者參與關鍵研究部分,結果顯示Socazolimab療效良好,腫瘤應答率得到改善,並與患者PD-L1表達水平無關;應答持續時間、無進展生存期及總生存期均得到延長。

Socazolimab為獲Sorrento Therapeutics, Inc("Sorrento")授權於中國大陸、香港、澳門及台灣生產的引進藥品。

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