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恆瑞醫藥(600276.SH):脯氨酸恆格列淨片聯合厄貝沙坦治療合併高血壓的2型糖尿病腎病獲批臨牀試驗
格隆匯 08-28 17:04

格隆匯 8 月 28日丨恆瑞醫藥(600276.SH)公佈,公司及子公司上海恆瑞醫藥有限公司近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的《藥物臨牀試驗批准通知書》,並將於近期開展臨牀試驗。

根據《中華人民共和國藥品管理法》及有關規定,經審查,2020526日受理的脯氨酸恆格列淨片(規格10mg)符合藥品註冊的有關要求,同意按照提交的方案開展臨牀試驗。申請的適應症:本品聯合厄貝沙坦治療合併高血壓的2型糖尿病腎病。

脯氨酸恆格列淨片擬適用於治療2型糖尿病,與厄貝沙坦聯合用藥擬適用於治療合併高血壓的2型糖尿病腎病。經查詢,目前已有同類產品獲批上市,如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和默沙東的埃格列淨;另有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僅在日本上市。經查詢PharMarket市場數據庫,上述藥物2019年全球銷售額約為108億美元。

截至目前,該產品累計已投入研發費用約為22845萬元。

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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