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現代製藥(600420.SH):雙氯芬酸鈉緩釋片通過仿製藥一致性評價
格隆匯 01-17 20:50

格隆匯1月17日丨現代製藥(600420.SH)公佈,近日,公司控股子公司國藥集團致君(深圳)坪山製藥有限公司(以下簡稱“致君坪山”)收到國家藥品監督管理局核准簽發的雙氯芬酸鈉緩釋片(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。

雙氯芬酸鈉緩釋片是一種非甾體消炎鎮痛藥,主要適用於急慢性關節炎、急慢性強直性脊椎炎;肩周炎、滑囊炎、肌腱炎及腱鞘炎;腰背痛、扭傷、勞損及其他軟組織損傷;急性痛風;痛經或附件炎、牙痛和術後疼痛等。該藥品的原研品種為諾華製藥的雙氯芬酸鈉緩釋片(0.1g),商品名為“Voltaren”。

根據PDB藥物綜合數據庫數據顯示,雙氯芬酸2018年在全球銷售額為50.50億美元。2018年致君坪山雙氯芬酸鈉緩釋片(0.1g)銷售收入(不含税)約為人民幣2億元。

CDE網站顯示,目前尚未有其他企業的雙氯芬酸鈉緩釋片(0.1g)通過一致性評價。國內擁有雙氯芬酸鈉緩釋片(0.1g)藥品生產批文的還有德州德藥製藥有限公司、湖南華納大藥廠有限公司和上海上藥信誼藥廠有限公司等。截至目前,致君坪山用於開展雙氯芬酸鈉緩釋片(0.1g)一致性評價累計研發投入約人民幣2,900萬元(未經審計)。

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