復星醫藥(600196.SH):朝暉藥業奮乃靜片通過仿製藥一致性評價
格隆匯9月30日丨復星醫藥(600196.SH)公佈,近日,公司控股子公司上海朝暉藥業有限公司(以下簡稱“朝暉藥業”)收到國家藥品監督管理局頒發的關於奮乃靜片的《藥品補充申請批准通知書》,該藥品通過仿製藥質量與療效一致性評價。
該藥品主要用於精神分裂症及嚴重的噁心和嘔吐的治療。2019年度,朝暉藥業該藥品於中國境內(不包括港澳台地區,下同)的銷售額約為人民幣1993萬元。
截至本公告日,其他於中國境內已上市的奮乃靜片主要包括山東博山製藥有限公司、江蘇黃河藥業股份有限公司、東北製藥集團瀋陽第一製藥有限公司、南京白敬宇製藥有限責任公司的奮乃靜片。根據IQVIACHPA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;IQVIACHPA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IQVIACHPA數據存在不同程度的差異),2019年度,奮乃靜片於中國境內銷售額約為人民幣2062萬元。
截至2020年9月,朝暉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1060萬元(未經審計)。
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