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安科生物(300009.SZ):控股子公司“重組抗HER2人源化HuA21單克隆抗體注射液”獲得藥物臨牀試驗默示許可
格隆匯 11-25 16:19

格隆匯 11 月 25日丨安科生物(300009.SZ)公佈,2020年11月24日,安徽安科生物工程(集團)股份有限公司控股子公司合肥瀚科邁博生物技術有限公司(“瀚科邁博”)從國家藥品監督管理局藥品審評中心網站(http://www.cde.org.cn/)獲悉,瀚科邁博申報的“重組抗HER2人源化HuA21單克隆抗體注射液”已獲臨牀試驗默示許可,受理號為:CXSL20****0國。

藥品名稱:重組抗HER2人源化HuA21單克隆抗體注射液;適應症:HER2過表達實體瘤;註冊分類:Ⅰ類生物製品。

表皮生長因子受體2(human epidermal growth factor receptor-2,簡稱HER2)是表皮生長因子受體家族蛋白的一員,通常在胎兒時期高表達,成年以後只在極少數組織內低水平表達。然而研究發現,HER2在包括乳腺癌、胃癌等多種類型的腫瘤中均存在基因擴增或過度表達,這類腫瘤惡性程度高,易轉移,且對傳統放療和化療不敏感。抗HER2腫瘤靶向單克隆抗體藥物是目前國際上公認的治療HER2過表達腫瘤有效的方案之一。

瀚科邁博研發的人源化HuA21抗體是自主開發的一款創新型HER2單克隆抗體。前期研究表明:HuA21具有與曲妥珠單抗及帕妥珠單抗均不同的蛋白序列和分子靶點。臨牀前研究表明HuA21與曲妥珠單抗或化療藥物聯用的抗腫瘤生長效果良好,食蟹猴毒理試驗中也顯示了良好的安全性,並且體外試驗中HuA21還具有較強的抑制腫瘤轉移作用。

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