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佐力藥業(300181.SZ):“重組人源化抗Claudin 18.2單克隆抗體注射液”獲臨牀試驗默示許可
格隆匯 12-04 17:49

格隆匯12月4日丨佐力藥業(300181.SZ)公佈,近日,經浙江佐力藥業股份有限公司在國家藥品監督管理局藥品審評中心網站(http://www.cde.org.cn)查詢,獲悉科濟生物醫藥(上海)有限公司(“科濟生物”)、愷興生命科技(上海)有限公司向國家藥品監督管理局提交的“重組人源化抗Claudin 18.2單克隆抗體注射液”獲得臨牀試驗默示許可。藥品名稱:重組人源化抗 Claudin 18.2 單克隆抗體注射液 ;適應症:Claudin18.2 陽性實體瘤。

Claudin(CLDN)是正常組織緊密連接最重要的一種蛋白質,具有4個跨膜結構域,參與機體生理過程如細胞旁通透性和電導的調節。其家族包含至少24個成員,其中CLDN18有CLDN18.1和CLDN18.2兩種異構體。以往研究表明,正常生理狀態下,CLDN18.2僅在人胃上皮短壽細胞表面表達;但在胃癌、食管癌、胰腺癌、肺癌、卵巢癌、結腸癌等多種腫瘤中高表達,比如在50%-80%的胃癌患者存在該靶點的表達。因此,CLDN18.2有可能成為胃癌、胰腺癌等實體腫瘤免疫治療的有效靶標。

獲得相關藥品臨牀試驗默示許可後,科濟生物將按國家臨牀試驗的要求組織開展臨牀試驗。

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