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復宏漢霖(02696.HK):帕妥珠單抗生物類似藥HLX11用於HER2陽性且HR陰性的早期或局部晚期乳腺癌新輔助治療的3期臨牀研究於中國境內完成首例患者給藥
格隆匯 04-28 20:43

格隆匯4月28日丨復宏漢霖(02696.HK)公吿,近日,公司自主開發的帕妥珠單抗生物類似藥HLX11(重組抗HER2結構域II人源化單克隆抗體注射液)(HLX11)用於HER2陽性且HR陰性的早期或局部晚期乳腺癌新輔助治療的3期臨牀研究於中國境內(不包括港澳台地區,下同)完成首例患者給藥。

本研究是一項多中心、隨機、雙盲、平行對照的3期臨牀試驗,旨在比較HLX11與原研帕妥珠單抗用於HER2陽性、HR陰性的早期或局部晚期乳腺癌患者新輔助治療的療效和安全性。合格的受試者將按1:1的比例隨機分為兩組,分別接受HLX11或原研帕妥珠單抗聯合曲妥珠單抗和多西他賽的治療,每三週一次,共四個週期。研究的主要終點為由獨立評審委員會(IRC)評估的總體病理完全緩解率(tpCR)。次要終點包括由研究者評估的tpCR、乳腺病理完全緩解率(bpCR)、客觀緩解率(ORR)、無事件生存期(EFS)、無病生存期(DFS)、安全性、藥代動力學和免疫原性。

截至本公吿日,於中國境內上市的帕妥珠單抗注射液僅有上海羅氏製藥有限公司的帕捷特。根據IQVIACHPA提供的資料,2021年,帕妥珠單抗注射液於中國境內的銷售額約為人民幣26.13億元。

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