景峯醫藥(000908.SZ):子公司鹽酸伊立替康注射液通過一致性評價
格隆匯7月19日丨景峯醫藥(000908.SZ)公佈,近日,公司子公司海南錦瑞製藥收到國家藥監局核准簽發的關於鹽酸伊立替康注射液(2ml:40mg;5ml:100m)的《藥品補充申請批准通知書》,子公司鹽酸伊立替康注射液通過仿製藥質量和療效一致性評價。
伊立替康是喜樹鹼的衍生物,特異性地作用於拓撲異構酶I。拓撲異構酶I通過可逆地斷裂DNA單鏈使DNA雙鏈解旋。伊立替康及其活性代謝產物SN-38結合到拓撲異構酶I-DNA複合物上,阻止斷裂的單鏈再連接。目前研究顯示伊立替康的細胞毒性作用是由於DNA雙鏈的破壞,而DNA雙鏈的破壞是由於在DNA合成中複製酶與由拓撲異構酶I、DNA、和伊立替康或SN-38構成的三元複合物發生相互作用所致。哺乳動物細胞不能有效地修復這種雙鏈的破壞。
鹽酸伊立替康注射液適用於晚期大腸癌患者的治療,可與5-氟尿嘧啶和亞葉酸聯合治療既往未接受化療的晚期大腸癌患者;也可以作為單一用藥,治療經含5-氟尿嘧啶化療方案治療失敗的患者。
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