海辰藥業(300584.SZ):伏格列波糖片通過仿製藥一致性評價
格隆匯10月28日丨海辰藥業(300584.SZ)公佈,公司於近日收到國家藥品監督管理局核准簽發的《藥品補充申請批准通知書》,伏格列波糖片通過仿製藥質量和療效一致性評價。
伏格列波糖片為口服類降糖藥,屬於α-葡萄糖苷酶抑制劑,在腸道內抑制將雙糖分解成單糖的α-葡萄糖苷酶,從而延遲糖分的消化和吸收,改善餐後高血糖。該產品主要用於改善糖尿病患者餐後高血糖(適用於患者接受飲食療法、運動療法沒有得到明顯效果時,或者患者除飲食療法、運動療法外還用口服降血糖藥物或胰島素製劑而沒有得到明顯效果時)。伏格列波糖片最早由武田製藥開發,有0.2mg和0.3mg兩種規格,1994年在日本上市,商品名為BASEN,1998年在中國上市,商品名為倍欣。伏格列波糖片現已在多個國家上市銷售,經查詢國家藥監局網站,除公司外,目前有天津武田、江蘇晨牌、辰欣藥業、北京雙鷺、浙江京新等多家公司獲批。該產品與阿卡波糖療效相當,適用範圍更廣,胃腸道副作用較小,臨牀應用價值較高。
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