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復星醫藥(02196.HK)附屬早期乳腺癌治療藥物獲藥品臨牀試驗通知書
格隆匯 01-21 17:01

格隆匯1月21日丨復星醫藥(02196.HK)發佈公告,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(以下簡稱“復宏漢霖”)及上海復宏漢霖生物製藥有限公司(以下簡稱“漢霖製藥”)收到國家藥監局關於同意其研製的重組抗HER2結構域II人源化單克隆抗體注射液(即HLX11;以下簡稱“該新藥”)用於轉移性乳腺癌、早期乳腺癌治療開展臨牀試驗的通知書。復宏漢霖及漢霖製藥擬於近期條件具備後於中國大陸境內(不包括港澳台地區,下同)開展該新藥的臨牀I期試驗。

該新藥為集團自主研發的帕妥珠單抗生物類似藥,主要用於轉移性乳腺癌、早期乳腺癌治療。

截至該公告日,於中國境內上市的重組抗HER2人源化單克隆抗體包括赫賽汀(注射用曲妥珠單抗)和帕捷特(帕妥珠單抗注射液)。根據IQVIACHPA最新數據(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年度及2019年1-9月,重組抗HER2人源化單克隆抗體產品於中國境內的銷售額分別約為人民幣27.3億元、34.4億元。

截至2019年12月,集團現階段針對該新藥累計研發投入為人民幣約5,156萬元(未經審計)。

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