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復星醫藥(02196.HK)乳腺癌治療新藥HLX11獲臨牀試驗申請受理
格隆匯 10-31 17:21

格隆匯10月31日丨復星醫藥(02196.HK)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及上海復宏漢霖生物製藥有限公司收到《受理通知書》,其研製的HLX11(生物類似藥,即重組抗HER2結構域II人源化單克隆抗體注射液)用於轉移性乳腺癌、早期乳腺癌治療獲國家藥品監督管理局臨牀試驗註冊審評受理。

該新藥為該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。截至本公告日,於中國境內(不包括港澳台地區,下同)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,2018年度,重組抗HER2人源化單克隆抗體產品於中國境內銷售額為人民幣約27.3億元。截至2019年9月,該集團現階段針對該新藥累計研發投入為人民幣約4,297萬元(未經審計)。

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