現代製藥(600420.SH):子公司頭孢地尼分散片(0.1g)通過一致性評價
格隆匯2月5日丨現代製藥(600420.SH)公佈,近日,公司控股子公司國藥致君收到國家藥品監督管理局核准簽發的頭孢地尼分散片(0.1g)《藥品補充申請批件》,批准該藥品通過仿製藥質量和療效一致性評價。
頭孢地尼主要適用於葡萄球菌屬、鏈球菌屬、肺炎球菌、流感嗜血桿菌等菌株所引起的下列感染:咽喉炎、扁桃體炎、急性支氣管炎、肺炎;中耳炎、鼻竇炎;宮內感染、前庭大腺炎;乳腺炎、外傷或手術傷口的繼發感染;毛囊炎、慢性膿皮症;眼瞼炎、麥粒腫、瞼板腺炎等。該藥品的原研品種為AstellasPharmaInc.的頭孢地尼膠囊,商品名為“Cefzon”。
根據PDB藥物綜合數據庫數據顯示,頭孢地尼2018年全球銷售額為3.94億美元。2018年國藥致君頭孢地尼分散片(0.1g)銷售收入(不含税)約為人民幣1.5億元。
CDE網站顯示,目前尚無其他公司的頭孢地尼分散片(0.1g)通過一致性評價。國內擁有頭孢地尼分散片(0.1g)藥品生產批文的還有天津市中央藥業有限公司、海南日中天製藥有限公司、江蘇亞邦強生藥業有限公司等。截至目前,國藥致君用於開展頭孢地尼分散片(0.1g)一致性評價累計研發投入約人民幣1700萬元(未經審計)。
公司表示,子公司國藥致君頭孢地尼分散片(0.1g)通過一致性評價將有利於該產品未來的市場銷售和市場競爭。
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