華東醫藥(000963.SZ):二甲雙胍恩格列淨片(I)獲批上市
格隆匯6月7日丨華東醫藥(000963.SZ)公佈,近日,公司全資子公司杭州中美華東製藥有限公司(“中美華東”)收到國家藥品監督管理局核准簽發的《藥品註冊證書》(證書編號:2021S00577),藥品通用名稱為二甲雙胍恩格列淨片(I)。
恩格列淨屬於鈉-葡萄糖共轉運體2 (SGLT-2)抑制劑,通過減少腎臟的葡萄糖重吸收,降低腎糖閾,促進葡萄糖從尿液排出。鹽酸二甲雙胍可減少肝糖生產,抑制葡萄糖的腸道吸收,並增加外周組織對葡萄糖的攝取和利用,可通過增加外周糖的攝取和利用而提高胰島素的敏感性。二甲雙胍為雙胍類口服降血糖藥物。二甲雙胍恩格列淨片是兩種作用機制互補的降血糖藥物複方,配合飲食和運動治療,用於經二甲雙胍單藥治療血糖仍控制不佳或正在接受二者聯合治療的2型糖尿病患者。該藥物原研廠家為勃林格殷格翰,於2015年獲得FDA批准,2019年在中國獲批。
截至目前,除原研企業外,國內僅有中美華東1家企業取得了二甲雙胍恩格列淨片藥品註冊證書。經IQVIA數據庫查詢,該產品2020年全球銷售額為5.05億美元,較2019年增長超過30%。
截至公吿日,公司二甲雙胍恩格列淨片累計直接的研發投入約人民幣1855萬元。
二甲雙胍恩格列淨片獲批上市將進一步豐富公司糖尿病產品管線,與公司現有糖尿病領域上市品種形成協同效應,有利於強化提升公司在糖尿病用藥領域的市場競爭力,鞏固公司在國內糖尿病治療領域的市場領先地位。
多年來,公司一直將糖尿病領域作為公司核心戰略領域之一,堅持以患者需求為核心,高度關注糖尿病患者尚未滿足的臨牀需求。未來,公司將繼續加強糖尿病產品佈局,持續加大對該領域的研發投入,不斷開發創新產品,為糖尿病患者帶來更先進的治療方案。
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