上海醫藥(02607.HK)藥品通過仿製藥一致性評價
上海醫藥(02607.HK)(601607.SH)公布,全資子公司上藥信誼及控股子公司山東信誼分別收到國家藥監局頒發的關於鹽酸二甲雙胍片(0.25g)及硝酸甘油片的《藥品補充申請批准通知書》,上述藥品通過仿製藥一致性評價。
鹽酸二甲雙胍片主要用於治療成人中的單純飲食控制及體育鍛煉治療無效的2型糖尿病,尤其是肥胖的2型糖尿病,由日本新藥株式會社研發,最早於1961年在日本上市。2019年12月,上藥信誼就鹽酸二甲雙胍片(0.25g)仿製藥一致性評價向國家藥監局提出申請並獲受理。
截至本公告日,公司針對鹽酸二甲雙胍片(0.25g)的一致性評價已投入研發費用約881.4萬元人民幣。
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