康恩貝(600572.SH):鹽酸吡格列酮片通過仿製藥質量和療效一致性評價
格隆匯10月20日丨康恩貝(600572.SH)公佈,近日,公司全資子公司杭州康恩貝製藥有限公司(“杭州康恩貝”)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》,杭州康恩貝生產的鹽酸吡格列酮片(“該藥品”)通過仿製藥質量和療效一致性評價。
鹽酸吡格列酮片主要用於治療2型糖尿病。2型糖尿病又稱非胰島素依賴型糖尿病或成人發病型糖尿病,是一種慢性代謝疾病,多在35~40歲之後發病,佔糖尿病患者90%以上。患者特徵為高血糖、相對缺乏胰島素、胰島素抵抗等,高血糖帶來的長期併發症包括心臟病、中風、糖尿病視網膜病變,可能導致失明、腎臟衰竭、甚至四肢血流不暢而需要截肢,少見併發糖尿病酮症酸中毒。該藥品可單獨服用,也可視情況與胰島素分泌促進劑或胰島素合併用藥。
截止公吿披露日,通過一致性評價的鹽酸吡格列酮片廠家有公司全資子公司杭州康恩貝等三家企業。
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