景峯醫藥(000908.SZ):注射用鹽酸吉西他濱通過仿製藥一致性評價
格隆匯6月15日丨景峯醫藥(000908.SZ)公佈,近日,公司子公司海南錦瑞製藥有限公司收到國家藥品監督管理局(“國家藥監局”)核准簽發的注射用鹽酸吉西他濱的《藥品補充申請批准通知書》,子公司注射用鹽酸吉西他濱通過仿製藥質量和療效一致性評價。
吉西他濱為嘧啶類抗代謝物,在細胞內經核苷激酶的作用被代謝為具有活性的二磷酸及三磷酸核苷,二磷酸和三磷酸核苷通過兩種作用機制抑制DNA合成,從而實現吉西他濱的細胞毒作用。
注射用鹽酸吉西他濱主要適用於治療局部晚期或已轉移的非小細胞肺癌或胰腺癌,也可以與紫杉醇聯合,用於治療經輔助/新輔助化療後復發,不能切除的、局部復發或轉移性乳腺癌。原研產品由禮來公司研發,現為國家醫保目錄乙類品種。目前,國內主要生產廠商有南京正大天晴製藥有限公司、齊魯製藥有限公司等。
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