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麗珠集團(000513.SZ):申報註冊的注射用醋酸奧曲肽微球已獲受理
格隆匯 02-17 17:36

格隆匯2月17日丨麗珠集團(000513.SZ)公佈,近日,公司全資附屬公司珠海市麗珠微球科技有限公司(“麗珠微球”)及麗珠集團麗珠製藥廠(“麗珠製藥廠”)收到國家藥品監督管理局(“藥監局”)核准簽發的《受理通知書》,由麗珠微球珠製藥廠申報註冊的注射用醋酸奧曲肽微球已獲受理

注射用醋酸奧曲肽微球歷經5年研發,該註冊申請已於2020120日獲得受理。

注射用醋酸奧曲肽微球長效緩釋製劑,每個月注射一次,用於

1下列肢端肥大症患者的治療:

皮下注射醋酸奧曲肽注射液已充分控制病情。

不適合外科手術、放療或治療無效的患者,或在放療充分發揮療效前,處於潛在反應階段的患者。

2伴有功能性胃腸胰內分泌腫瘤相關症狀的患者,已經用皮下注射醋酸奧曲肽注射液治療得到充分控制。

伴有類癌綜合徵特徵的類癌。

血管活性腸肽瘤。

胰高糖素瘤。

胃泌素瘤/卓-艾綜合徵。

胰島素瘤(用於術前低血糖的控制和維持治療)。

生長激素釋放因子腺瘤。

截至公告披露日,注射用醋酸奧曲肽微球累計直接投入的研發費用約人民幣1959.60萬元

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