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東陽光藥(01558.HK):阿立哌唑口崩片獲批准上市
格隆匯 05-24 19:12

格隆匯5月24日丨東陽光藥(01558.HK)公吿,公司自廣東東陽光藥業有限公司("廣東東陽光藥業")收購產品阿立哌唑口崩片(10mg及15mg)("該產品")已獲中國國家藥品監督管理局審批完畢並獲准上市。該產品的上市許可持有人為公司全資子公司東莞市陽康醫藥有限責任公司。

阿立哌唑用於治療精神分裂症,屬於第二代抗精神病藥物。目前認為阿立哌唑的作用機制是通過D2受體和5-HT1A受體的部分激動作用及5-HT2A受體的拮抗作用的介導而產生。與第一代抗精神病藥相比,阿立哌唑副作用較小及服用較簡單,增加了服藥依從性,使得病情更加穩定。

阿立哌唑是《國家基醫療保險、工傷保險和生育保險藥品目錄》2020年版中甲類品種,同時是《國家基藥物目錄》2018年版中品種。根據艾昆緯數據,2020年中國阿立哌唑藥物的銷售額約為9,796.56萬美元,較2019年增長約16.23%,是精神分裂症領域的主要用藥品種之一。

該產品為中國境內獲批准上市的仿製藥,獲批准上市後即為視同通過仿製藥質量和療效一致性評價的產品;該產品具有良好的臨牀應用價值和市場前景,上市後將成為公司在精神疾病治療領域的產品之一,在進一步豐富集團的產品組合的同時,也為廣大患者提供質價雙優的用藥選擇。

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