聖濟堂(600227.SH):阿卡波糖片獲得藥品註冊證書
格隆匯12月24日丨聖濟堂(600227.SH)公佈,2021年12月23日,公司全資子公司貴州聖濟堂製藥有限公司(以下簡稱“聖濟堂製藥”)收到了國家藥監局對公司藥品阿卡波糖片核准簽發的《藥品註冊證書》。
阿卡波糖是1975年德國拜耳公司研製的品種,是美國FDA批准的第一個α-葡萄糖苷酶抑制劑。阿卡波糖能有效延緩澱粉等多糖化合物在體內的水解,控制餐後血糖水平、降低糖基化血紅蛋白的作用,適合膳食結構以澱粉為主的人羣,是我國糖尿病口服降糖藥中銷量最大的品種。1994年進入中國市場,商品名拜唐蘋。收錄於《國家醫保目錄(2020年版)》為甲類藥品,入選2018年版國家基本藥物目錄。
截至目前:聖濟堂製藥在阿卡波糖片研發項目上已累計投入研發費用為人民幣 843.96萬元。阿卡波糖片的獲批,進一步豐富和完善了公司的產品線,目前聖濟堂製藥基本囊括了糖尿病治療藥品口服制劑常用的主要產品,將對公司的生產經營產生積極影響,同時也為公司其他產品申請上市工作開展積累了寶貴的經驗。
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