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健友股份(603707.SH):子公司注射用地西他濱獲批在美上市
格隆匯 07-05 15:37

格隆匯7月5日丨健友股份(603707.SH)公吿,公司子公司香港健友實業有限公司於近日收到美國食品藥品監督管理局簽發的注射用地西他濱,50mg/瓶 ANDA 批准通知(ANDA號:212959)。

注射用地西他濱適用於IPSS(InternationalPrognosticScoringSystem)評分系統中中危-1,中危-2和高危的初治、復治骨髓增生異常綜合徵(MDS)成人患者,包括原發性和繼發性的MDS,按照FAB(French-American-British)分型所有的亞型:難治性貧血,難治性貧血伴環形鐵粒幼細胞增多,難治性貧血伴原始細胞過多,難治性貧血伴有原始細胞增多-轉變型,慢性粒-單核細胞白血病。

新批准產品近期將安排在美國上市銷售,有望對公司今年經營業績產生積極影響。

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