復星醫藥(02196.HK)控股子公司藥品獲註冊批准
格隆匯 12 月 7日丨復星醫藥(02196.HK)發佈公告,近日,公司控股子公司上海復宏漢霖生物技術股份有限公司及其控股子公司研製的阿達木單抗注射液(即重組抗TNFα全人單克隆抗體注射液,商品名稱:漢達遠®;以下簡稱“該新藥”)用於治療類風濕關節炎、強直性脊柱炎、銀屑病的上市註冊申請獲國家藥品監督管理局批准。
該新藥為集團自主研發的單抗生物類似藥,主要用於類風濕關節炎、強直性脊柱炎、銀屑病的治療。該新藥的生產場地及設施已通過上海市藥品監督管理局的GMP符合性現場檢查。
截至該公告日,於中國大陸境內(不包括港澳台地區,下同)上市的阿達木單抗為艾伯維的修美樂®、浙江海正藥業股份有限公司的安健寧®、百奧泰生物科技(廣州)有限公司的格樂立®。根據IQVIACHPA資料(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,阿達木單抗於中國境內的銷售額約為人民幣0.32億元。截至2020年10月,集團現階段針對該新藥累計研發投入約為人民幣26,410萬元(未經審計)。
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