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復宏漢霖(02696.HK)HLX02注射用曲妥珠單抗上市註冊申請獲批准 同類品種2019年於中國銷售額達45.72億
格隆匯 08-14 19:47

格隆匯8月14日丨復宏漢霖(02696.HK)公佈,近日,公司自主開發的HLX02注射用曲妥珠單抗(中國境內商品名:漢曲優)的上市註冊申請(NDA)獲國家藥品監督管理局批准,用於治療:1)HER2陽性的早期乳腺癌;2)HER2陽性的轉移性乳腺癌;3)HER2陽性的轉移性胃腺癌或胃食管交界處腺癌,即原研曲妥珠單抗在中國已獲批的所有適應症。

HLX02注射用曲妥珠單抗(中國境內商品名:漢曲優)是公司按照中國及歐盟生物類似藥指導原則自主開發的單抗生物類似藥,用於HER2陽性的早期乳腺癌、HER2陽性的轉移性乳腺癌及未經治療的HER2陽性的轉移性胃腺癌或胃╱食管交界處腺癌適應症治療。

此次HLX02注射用曲妥珠單抗獲NMPA上市註冊申請(NDA)批准主要基於對其一系列研究數據的審查,包括質量對比研究、臨牀前研究及臨牀1期和國際多中心臨牀3期研究相關數據。這些數據證明了HLX02注射用曲妥珠單抗(中國境內商品名:漢曲優)與原研曲妥珠單抗高度相似,在產品質量、藥理學、藥代動力學、藥效動力學、毒理學、免疫原性、安全性和有效性等方面與原研曲妥珠單抗沒有臨牀意義上的差異。

截至本公告日,於中國境內(不包括港澳台地區,下同)上市的曲妥珠單抗為羅氏的赫賽汀。根據IQVIACHAP資料,2019年曲妥珠單抗於中國境內的銷售金額約為45.72億人民幣。

公司表示,HLX02注射用曲妥珠單抗是首個於中國境內獲批上市的國產曲妥珠單抗,也是繼漢利康(利妥昔單抗注射液)後,公司第二個於中國境內獲批上市的單克隆抗體生物類似藥產品。HLX02注射用曲妥珠單抗(中國境內商品名:漢曲優)的此次獲批上市有利於進一步豐富公司於中國境內實現商業化的產品線,併為國內HER2陽性的乳腺癌及胃癌患者帶來更多的治療選擇。

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