復星醫藥:注射用曲妥珠單抗用於轉移性乳腺癌適應症治療的III期臨牀研究已達到預設的主要終點
格隆匯10月31日丨復星醫藥(600196.SH)公佈,近日,公司控股子公司上海復宏漢霖生物技術股份有限公司(“復宏漢霖”)研製的注射用曲妥珠單抗(生物類似藥,即注射用重組抗HER2人源化單克隆抗體;以下簡稱“該新藥”)用於轉移性乳腺癌適應症治療的III期臨牀研究已達到預設的主要終點。
該新藥為集團自主研發的單克隆抗體生物類似藥,主要用於轉移性乳腺癌適應症及轉移性胃癌適應症等。截至公告日,該產品用於乳腺癌適應症治療分別於中國境內(不包括港澳台地區,下同)及烏克蘭、波蘭、菲律賓等國處於III期臨牀試驗中。
該新藥的全球III期臨牀試驗是在復發或既往未經治療的HER2陽性轉移性乳腺癌患者中開展的隨機、雙盲、國際多中心試驗,其目的是比較該新藥與於歐洲上市的原研藥曲妥珠單抗(赫賽汀®;以下簡稱“原研藥”)治療轉移性乳腺癌的療效、安全性、藥代動力學及免疫原性,是證明該新藥和原研藥生物相似性最重要的試驗之一。此次分析結果顯示,該新藥在治療復發或既往未經治療的HER2陽性轉移性乳腺癌的療效與原研藥等效,其治療一年的安全性、免疫原性結果與原研藥相似。
截至公告日,於中國境內上市的曲妥珠單抗為羅氏的赫賽汀®。根據IQVIA CHPA資料(由IQVIA提供,IQVIA是全球領先的醫藥健康產業專業信息和戰略諮詢服務提供商),2018年度,赫賽汀®於中國境內的銷售額約為人民幣27.3億元。
截至2019年9月,集團現階段針對該新藥(包括轉移性乳腺癌適應症及轉移性胃癌適應症)累計投入人民幣約6.403億元(未經審計)。
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