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恆瑞醫藥(600276.SH):"脯氨酸恆格列淨片"獲批臨牀
格隆匯 11-12 15:35

格隆匯11月12日丨恆瑞醫藥(600276.SH)公佈,近日收到國家藥品監督管理局(以下簡稱“國家藥監局”)核准簽發的關於脯氨酸恆格列淨片的《藥物臨牀試驗批准通知書》,並將於近期開展臨牀試驗。

脯氨酸恆格列淨片是一種SGLT2抑制劑,擬用於治療射血分數降低的慢性心力衰竭。經查詢,SGLT2抑制劑上市產品包括阿斯利康的達格列淨、強生的坎格列淨、勃林格殷格翰的恩格列淨、默沙東的埃格列淨,以及安斯泰來製藥的伊格列淨、中外製藥的託格列淨和大正製藥的魯格列淨;其中,阿斯利康的達格列淨已獲批用於治療射血分數下降型心力衰竭。經查詢PharMarket市場數據庫,SGLT2抑制劑2019年全球銷售額為52.59億美元。

截至目前,該產品累計已投入研發費用約為24,012萬元。

根據我國藥品註冊相關的法律法規要求,藥物在獲得藥物臨牀試驗批准通知書後,尚需開展臨牀試驗並經國家藥監局審評、審批通過後方可生產上市。

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