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通化東寶(600867.SH):西格列汀二甲雙胍片(Ⅱ)獲得藥品註冊批件
格隆匯 10-20 18:05

格隆匯10月20日丨通化東寶(600867.SH)公佈,公司近日收到國家藥品監督管理局核准簽發的西格列汀二甲雙胍片(Ⅱ)《藥品註冊證書》。

截至2021年9月30日,公司在該研發項目中已累計投入1260.44萬元。

磷酸西格列汀是一種口服的高度選擇性DPP-4類小分子抑制劑,DPP-4抑制劑其降糖機制完全不同於其他降糖藥,它不直接刺激胰島,而是通過促進腸道內腸促胰素的分泌,實現對胰島素分泌的靈活控制,被稱為“智能”降糖藥;二甲雙胍是目前糖尿病用藥指南推薦的一線用藥。研究表明,將磷酸西格列汀與傳統降糖藥二甲雙胍聯合使用,能夠更有效平穩的控制血糖。據此公司開發了西格列汀二甲雙胍片複方製劑,將兩藥合併在1片中使用,複方製劑方便患者服藥,提高了患者依從性,可用於經二甲雙胍單藥治療血糖仍控制不佳或正在接受兩者聯合治療的2型糖尿病患者。

近年來國內DPP-4抑制劑市場規模呈明顯上升趨勢,根據默沙東財報,2020年默沙東的西格列汀二甲雙胍片全球銷售額為19.71億美元。同樣隨着西格列汀二甲雙胍片進入國家醫保,其在國內的銷售額也不斷增長。根據醫藥魔方數據顯示,中國城市公立醫院、縣級公立醫院西格列汀二甲雙胍片(Ⅱ)(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850mg)(商品名:“捷諾達”)2020年銷售金額為1.56億元人民幣,2016年至2020年年複合增長率為66.13%。

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