復星醫藥(02196.HK)控股子公司獲藥品註冊補充申請受理
格隆匯 1 月 18日丨復星醫藥(02196.HK)發佈公吿,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上海復宏漢霖生物製藥有限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:漢達遠®,以下簡稱“該新藥”)新增葡萄膜炎適應症獲國家藥品監督管理局藥品註冊補充申請審評受理。
該新藥為集團自主研發的單克隆抗體生物類似藥,2020年12月已獲批於中國大陸境內(不包括港澳台地區,下同)上市,獲批上市的適應症為銀屑病、類風濕關節炎、強直性脊柱炎。本次向國家藥監局提出相關補充申請,主要為該新藥新增葡萄膜炎適應症。
截至本公吿日,於中國大陸境內上市的其他阿達木單抗注射液主要包括艾伯維的修美樂®、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®等。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數據代表中國大陸境內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,阿達木單抗注射液於中國大陸境內的銷售額約為人民幣0.32億元。截至2020年12月,本、集團現階段針對該新藥(包括已獲批上市適應症及葡萄膜炎適應症)累計研發投入約為人民幣26,615萬元(未經審計)。
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