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復宏漢霖(02696.HK)治療乳腺癌注射液臨床試驗申請獲國家藥監局批准
阿思達克 01-21 17:38

復宏漢霖(02696.HK)公布,公司研製的用於轉移性乳腺癌、早期乳腺癌治療的重組抗HER2結構域II人源化單克隆抗體注射液的臨床試驗申請已於近日獲國家藥品監督管理局批准。

公司指,HLX11是其自主研發的帕妥珠單抗(Pertuzumab,商品名:Perjeta/帕捷特)的生物類似藥,主要適用於轉移性乳腺癌,聯合曲妥珠單抗和多西他賽,用於治療既往未接受過抗HER2治療或化療的HER2陽性、轉移性或不可切除的局部復發性乳腺癌患者,及早期乳腺癌,與曲妥珠單抗和化療聯合,作為早期乳腺癌整体治療方案的一部分,用於HER2陽性、局部晚期、炎性或早期乳腺癌患者的新輔助治療;用於具有高復發風險的HER2陽性早期乳腺癌患者的輔助治療。去年10月31日,用於轉移性乳腺癌、早期乳腺癌治療的HLX11的臨床試驗申請獲國家藥品監督管理局受理。

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