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海正藥業(600267.SH):注射用鹽酸表柔比星通過仿製藥一致性評價
格隆匯 03-23 16:49

格隆匯3月23日丨海正藥業(600267.SH)公佈,近日,公司收到國家藥監局核准簽發的注射用鹽酸表柔比星的《藥品補充申請批准通知書》,公司的注射用鹽酸表柔比星已通過仿製藥質量和療效一致性評價。

注射用鹽酸表柔比星主要適用於治療惡性淋巴瘤、乳腺癌、肺癌、軟組織肉瘤、食道癌、胃癌、肝癌、胰腺癌、黑色素瘤、結腸直腸癌、卵巢癌、多發性骨髓瘤、白血病。注射用鹽酸表柔比星原研產品由意大利法瑪西亞研發,1998年在中國上市,目前為國家醫保目錄乙類品種。目前,國內主要生產廠商有山東新時代藥業有限公司、北京協和藥廠等。截至目前,公司針對該藥品仿製藥質量和療效一致性評價已投入約2369.66萬元人民幣。

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