四環醫藥(00460.HK):惠升生物研發的達格列淨片獲國家藥監局上市批準
格隆匯4月23日丨四環醫藥(00460.HK)公告,集團旗下非全資附屬公司惠升生物製藥股份有限公司研發的達格列淨片已獲中國國家藥品監督管理局頒發的藥品註冊批件,用於2型糖尿病成人患者,視同通過仿製藥品質和療效一致性評價。
達格列淨片爲全球首款獲批上市的SGLT-2(鈉-葡萄糖協同轉運蛋白-2)抑制劑。SGLT-2抑制劑是目前國際上極受推薦的治療2型糖尿病的一種新型口服降糖藥物,其通過選擇性抑制腎臟近曲小管的SGLT-2受體,減少葡萄糖的重吸收而促進尿糖排泄,進而降低血糖濃度。SGLT-2抑制劑不僅具有良好的降糖作用,同時具有心血管、腎臟保護等多重獲益,獲國內外多領域指南推薦。該產品爲國家醫保產品,國家基本藥物。
達格列淨片是惠升生物繼脯氨酸加格列淨片(1類創新藥)、恩格列淨片後獲得上市批準的第三個SGLT-2抑制劑類藥物。達格列淨片的獲批,不僅進一步完善了集團及惠升生物在糖尿病治療領域的產品佈局,並可爲糖尿病患者提供更優的治療選擇,幫助更多患者實現更好的血糖管理,降低併發症風險,從而全面提升患者的生活品質和長期預後,切實造福廣大糖尿病患者羣體。
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