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海正藥業(600267.SH):注射用鹽酸伊達比星通過仿製藥一致性評價
格隆匯 06-26 17:45

格隆匯6月26日丨海正藥業(600267.SH)公佈,公司全資子公司瀚暉製藥有限公司(簡稱“瀚暉製藥”)收到國家藥品監督管理局核准簽發的注射用鹽酸伊達比星《藥品補充申請批准通知書》,瀚暉製藥藥品注射用鹽酸伊達比星已通過仿製藥質量和療效一致性評價。

注射用鹽酸伊達比星適用於成人未經治療的急性非淋巴細胞性白血病(ANLL)的誘導緩解和成人復發和難治性ANLL的誘導緩解,以及用於成人和兒童急性淋巴細胞性白血病(ALL)的二線治療,原研是輝瑞公司。目前,注射用鹽酸伊達比星國內主要生產廠商有南京正大天晴製藥有限公司、輝瑞製藥(無錫)有限公司、瀚暉製藥等。

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