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康恩貝:鹽酸坦索羅辛緩釋膠囊獲仿製藥一致性評價
格隆匯 02-10 15:40

格隆匯2月10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(以下簡稱“杭州康恩貝”)收到國家藥品監督管理局頒發的關於鹽酸坦索羅辛緩釋膠囊的《藥品補充申請批件》,該藥品通過仿製藥一致性評價。

鹽酸坦索羅辛緩釋膠囊,屬治療良性前列腺增生症用藥,為選擇性α1腎上腺素受體阻斷劑,用於治療前列腺增生症引起的排尿障礙。其主要作用機理是選擇性地阻斷前列腺中的α1A腎上腺素受體,鬆弛前列腺平滑肌,從而改善良性前列腺增生所致的排尿困難等症狀。

截至本公告日,通過國家藥監局一致性評價的鹽酸坦索羅辛緩釋膠囊廠家有公司全資子公司杭州康恩貝和江蘇恆瑞醫藥股份有限公司、浙江海力生製藥有限公司三家企業。根據中康資訊數據顯示:2018年相應終端市場鹽酸坦索羅辛緩釋膠囊銷售額約為16億元,杭州康恩貝該藥品的銷售額為2.4億元,佔比15%。截至目前,杭州康恩貝針對該藥品一致性評價已投入研發費用約人民幣1582萬元。

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