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恒瑞醫藥(600276.SH):恒格列淨二甲雙胍緩釋片(Ⅰ)、(Ⅱ)獲得藥品註冊證書
格隆匯 01-07 15:41

格隆匯1月7日丨恒瑞醫藥(600276.SH)公佈,公司子公司山東盛迪醫藥有限公司收到國家藥品監督管理局核准簽發的《藥品註冊證書》。恒格列淨二甲雙胍緩釋片(Ⅰ)、(Ⅱ)是公司自主研發的鈉-葡萄糖協同轉運體2(SGLT2)抑制劑恒格列淨與二甲雙胍的固定劑量複方緩釋製劑。此次恒格列淨二甲雙胍緩釋片(Ⅰ)、(Ⅱ)的獲批主要依據恒格列淨與二甲雙胍聯合治療的Ⅲ期臨牀研究(已上市)和兩項Ⅰ期臨牀研究(即生物等效性研究HR20031-101和食物影響研究HR20031-102),本產品通過機制互補覆蓋多重病理生理機制和多個靶點,兼具降糖和心腎保護,安全性良好,且與二者單藥自由聯合相比,複方製劑可通過減少服用藥片數量簡化降糖方案,有利於提高患者的治療依從性。

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