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麗珠集團(000513.SZ):注射用阿立哌唑微球臨牀試驗申請已獲受理
格隆匯 02-17 17:34

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”)收到國家藥品監督管理局(“藥監局”)核准簽發的《受理通知書》,由麗珠微球申報的注射用阿立哌唑微球臨牀試驗申請已獲受理

“注射用阿立哌唑微球”歷經5年研發,臨牀試驗申請已於2020213日獲得受理。

“注射用阿立哌唑微球”是阿立哌唑的長效緩釋製劑,每個月注射一次,降低給藥頻次,從而改善患者用藥的依從性,其主要用於治療成人精神分裂症。

截至公告披露日,“注射用阿立哌唑微球”累計直接投入的研發費用約人民幣1028.84萬元。

根據藥監局官網數據庫顯示目前國內未有產品獲批上市未有廠家獲批臨牀未有其他廠家申報臨牀。

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