復星醫藥(600196.SH):鹽酸阿米替林片通過仿製藥一致性評價
格隆匯8月16日丨復星醫藥(600196.SH)公佈,近日,公司控股子公司湖南洞庭藥業股份有限公司(“洞庭藥業”)收到國家藥品監督管理局頒發的關於鹽酸阿米替林片的《藥品補充申請批准通知書》(通知書編號:2020B04328),該藥品通過仿製藥質量與療效一致性評價。
該藥品屬於三環類抗抑鬱藥,主要用於治療焦慮性或激動性抑鬱症。2019年度,洞庭藥業該藥品於中國境內(不包括港澳台地區,下同)的銷售額約人民幣2233萬元。
截至公告日,於中國境內已上市的鹽酸阿米替林片包括洞庭藥業、常州四藥製藥有限公司、江蘇恩華藥業股份有限公司的鹽酸阿米替林片。根據IQVIA CHPA最新數據(由IQVIA提供,IQVIA是全球領先的醫藥健康產業專業信息和戰略諮詢服務提供商;IQVIA CHPA數據代表中國境內100張牀位以上的醫院藥品銷售市場,不同的藥品因其各自銷售渠道佈局的不同,實際銷售情況可能與IQVIA CHPA數據存在不同程度的差異),2019年度,鹽酸阿米替林片於中國境內銷售額約為人民幣795萬元。
截至2020年7月,洞庭藥業現階段針對該藥品一致性評價累計研發投入約為人民幣983萬元(未經審計)。
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