華東醫藥(000963.SZ)：獲得西格列汀二甲雙胍片藥品註冊證書
格隆匯 11 月 30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：2020S00767)。
藥品通用名稱：西格列汀二甲雙胍片(I)；劑型：片劑；規格：每片含磷酸西格列汀50mg(以西格列汀計)和鹽酸二甲雙胍500mg；申請事項：藥品註冊(境內生產)；註冊分類：化學藥品4類；藥品有效期：24個月；上市許可持有人：杭州中美華東製藥有限公司；生產企業：杭州中美華東製藥有限公司；藥品批准文號：國藥準字H20203614；審批結論：根據《中華人民共和國藥品管理法》及有關規定，經審查，本品符合藥品註冊的有關要求，批准註冊，發給藥品註冊證書。
西格列汀屬於強效、高選擇性的二肽基肽酶-4(DPP-4)抑制劑，二甲雙胍為雙胍類口服降血糖藥物，西格列汀二甲雙胍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。該藥物原研廠家為默沙東，於2007年獲得FDA批准，2012年在中國獲批。默沙東年報顯示，其該產品2019年銷售額為20.41億美元。
截至目前，除原研企業外，國內共有2家企業(含公司)取得了西格列汀二甲雙胍片藥品註冊證書。經米內網數據庫查詢，2019年國內公立醫療機構西格列汀二甲雙胍片終端銷售額約為人民幣1.01億元，均為原研銷售數據，較2018年增長超過20%。
截至公告日，公司西格列汀二甲雙胍片累計直接投入的研發費用約為人民幣2400萬元。
西格列汀二甲雙胍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。
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