麗珠醫藥(01513.HK)注射用醋酸奧曲肽微球獲得藥品受理通知書
格隆匯2月17日丨麗珠醫藥(01513.HK)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及麗珠集團麗珠製藥廠收到國家藥品監督管理局核准簽發的《受理通知書》,由麗珠微球及麗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2020年1月20日獲得受理。“注射用醋酸奧曲肽微球”為長效緩釋製劑,每個月注射一次,其可用於下列肢端肥大症患者的治療及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。截至本公告披露日,“注射用醋酸奧曲肽微球”累計直接投入的研發費用約為人民幣1,959.60萬元。
根據藥監局官網數據庫顯示,目前該產品國內有1家企業獲批上市。根據IQVIA抽樣統計估測數據,“注射用醋酸奧曲肽微球”2018年國內終端銷售金額約為人民幣1.09億元,2019年前三季度國內終端銷售金額約為人民幣1.16億元。另有1家企業已獲批臨牀,未有其他廠家申報。
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