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翰宇藥業(300199.SZ):利那洛肽膠囊獲得藥物臨牀試驗批准
格隆匯 05-15 18:01

格隆匯5月15日丨翰宇藥業(300199.SZ)公佈,2023年5月11日,公司收到國家藥品監督管理局下發的利那洛肽膠囊臨牀試驗批准通知書(通知書編號:2023LP00875),公司“利那洛肽膠囊”獲得藥物臨牀試驗批准。

利那洛肽是全球首個鳥苷酸環化酶-C(GC-C)激動劑,由美國Ironwood公司研發,於2012年8月經FDA批准上市,商品名為Linzess,適應症為成人慢性特發性便祕(CIC)和IBS-C。於2019年1月15日經國家藥品監督管理局(NMPA)批准利在中國上市,商品名為令澤舒。目前該藥品國內市場由AstraZeneca(阿斯利康)一家獨佔,尚無仿製上市。

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