科倫藥業(002422.SZ)：恩格列淨片獲藥品註冊證書
格隆匯 8 月 14日丨科倫藥業(002422.SZ)公佈，公司於近日獲得國家藥品監督管理局核准簽發的化學藥品“恩格列淨片”的《藥品註冊證書》。
恩格列淨片為勃林格殷格翰和禮來共同開發的鈉-葡萄糖共轉運蛋白2抑制劑(SGLT2i)，2014年在歐盟獲批，後相繼在美國、日本等多個國家獲批上市，2017年在中國批准進口，適用於配合飲食和運動，單藥或聯合二甲雙胍改善2型糖尿病患者的血糖控制。
中國2型糖尿病患者超過1億人，約60%的患者至少有1種併發症，其中心血管和腎臟併發疾病是患者致殘和致死的主要原因。SGLT2i為目前唯一被證實同時具有心血管和腎臟獲益的新機制口服降糖藥，已被美國糖尿病學會《2020糖尿病醫學診療標準》、中華醫學會糖尿病學分會《2020中國成人2型糖尿病患者糖化血紅蛋白控制目標及達標策略專家共識》、歐洲糖尿病研究協會《2019糖尿病，糖尿病前期和心血管疾病》等國內外權威指南或專家共識推薦作為糖尿病合併心血管或腎病患者的優選用藥。
恩格列淨片為目前臨牀最常用的SGLT2i之一，除可有效控制血糖外，還在美國獲批用於降低2型糖尿病患者的心血管風險，且臨牀研究顯示其可降低糖尿病患者新發腎病和腎病惡化的風險，2019年全球銷售額高達49億美元。恩格列淨片為科倫首個獲批進入糖尿病領域的藥物，未來將與公司已申報的卡格列淨片、西格列汀片等及在研的多個新型降糖藥，共同形成糖尿病領域的優勢產品集羣。
2015年國家藥監政策改革，要求新申報的仿製藥必須與原研質量和療效一致。公司本次獲批的恩格列淨片(10mg；25mg)即是按照這一要求研發，並以國產第2家獲批。藥監局公佈的原研產品信息如下：商品名：Jardiance(歐唐靜)，持證商：Boehringer Ingelheim International GmbH。
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