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通化東寶(600867.SH):恩格列淨片申報生產獲得受理通知
格隆匯 02-09 15:41

格隆匯2月9日丨通化東寶(600867.SH)公佈,公司於近日收到國家藥品監督管理局下發的恩格列淨片申報生產的《受理通知書》,截至本公吿日,公司在該項目中已投入研發費用人民幣約2496.05萬元。根據《中華人民共和國行政許可法》第三十二條的規定,經審查,決定予以受理。

鈉-葡萄糖協同轉運蛋白-2(SGLT2)抑制劑是一類新型的非胰島素依賴型口服降糖藥物,而恩格列淨是一種高選擇性SGLT2抑制劑,擁有獨特的不依賴胰島素的降糖機制,即通過減少腎臟的葡萄糖重吸收,降低腎糖閾,促進葡萄糖從尿液中直接排出。主要用於改善2型糖尿病患者的血糖控制。

恩格列淨片由勃林格殷格翰公司(Boehringer Ingelheim)和禮來(Lilly)聯合開發,最早於2014年5月在歐盟獲批上市,隨後在美國、日本上市,商品名:Jardiance,用於治療2型糖尿病;2017年9月在中國上市,商品名:歐唐靜?。2020年起國產仿製藥陸續獲批並過評,目前國內有1家進口,5家國產上市。公司該產品按照仿製藥質量與療效一致性評價註冊申報,若批准即視同通過一致性評價。

根據米內網數據顯示,原研的恩格列淨片 2020年在中國城市公立醫院、縣級公立醫院、城市社區中心及鄉鎮衞生院(簡稱中國公立醫療機構)終端及中國城市實體藥店終端合計銷售額超過1億元,較2019年增長率達374.64%。

恩格列淨片於2021年被納入了第四批國家集中帶量採購目錄,隨着第四批國採落地執行,各仿製企業在中國公立醫療機構終端迎來銷售放量。而在中國城市實體藥店終端,恩格列淨片的銷售額也在穩步增長。

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