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步長製藥(603858.SH):鹽酸特比萘芬片通過一致性評價
格隆匯 01-04 16:37

格隆匯1月4日丨步長製藥(603858.SH)宣佈,公司於近日獲悉,公司全資子公司保定天浩收到國家藥品監督管理局核准簽發的關於鹽酸特比萘芬片的《藥品補充申請批准通知書》(通知書編號:2020B05299),該藥品通過仿製藥質量和療效一致性評價。

鹽酸特比萘芬片用於治療皮膚真菌感染引起的手足甲真菌病(甲廯)。治療前應通過對患者的指/趾甲標本進行實驗室檢測【氫氧化鉀塗片、真菌培養或者指/趾甲活檢】確診甲廯。

經米內網查詢,2016年至2019年中國(城市公立,城市社區,縣級公立,鄉鎮衞生)樣本醫院年度銷售趨勢顯示,鹽酸特比萘芬片銷售額依次為2.0299億元、2.0014億元、1.8582億元、1.954億元。

截至目前,公司在該藥品一致性評價累計研發投入約為1575萬元人民幣。

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