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恒瑞醫藥(600276.SH):鹽酸伊立替康脂質體注射液(Ⅱ)獲得藥品註冊證書
格隆匯 01-07 15:39

格隆匯1月7日丨恒瑞醫藥(600276.SH)公佈,公司收到國家藥品監督管理局核准簽發的《藥品註冊證書》。鹽酸伊立替康是喜樹鹼的半合成衍生物。喜樹鹼可特異性地與拓撲異構酶I結合,後者誘導可逆性單鏈斷裂,從而使DNA雙鏈結構解旋;鹽酸伊立替康及其活性代謝物SN-38可與拓撲異構酶I-DNA複合物結合,從而阻止斷裂單鏈的再連接。通過臨牀前藥代動力學與藥效學數據表明,伊立替康脂質體具有顯著的腫瘤靶向性。與伊立替康普通製劑相比,伊立替康脂質體低劑量即可達到常規藥物同等暴露量,且持續抑制腫瘤生長、抑瘤作用強3。目前,鹽酸伊立替康脂質體(Ⅱ)聯合5-FU/LV和奧沙利鉑一線治療胰腺癌的Ⅲ期臨牀研究(NCT05751850)也正在開展中,除此之外,本品也在結直腸癌、食管癌等領域進行探索,未來有望惠及更多消化道腫瘤患者。

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