復星醫藥(600196.SH):阿達木單抗注射液獲批新增葡萄膜炎適應症
格隆匯4月12日丨復星醫藥(600196.SH)宣佈,近日,公司控股子公司復宏漢霖-B(02696.HK)及其控股子公司收到國家藥品監督管理局頒發的關於阿達木單抗注射液(即重組抗TNFα全人單克隆抗體注射液,商品名稱:漢達遠®)的《藥品補充申請批准通知書》(通知書編號:2021B00854),該藥品新增獲批葡萄膜炎適應症。
該藥品為集團自主研發的單克隆抗體藥物,2020年12月於中國內地獲批上市,首次獲批適應症為類風濕關節炎、強直性脊柱炎、銀屑病。
截至該公吿日,於中國內地獲批上市的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®、百奧泰生物製藥股份有限公司的格樂立®。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數據代表中國內地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),2020年度,阿達木單抗注射液於中國內地的銷售額約為人民幣1.90億元。
截至2021年3月,集團現階段針對該藥品(包括首次獲批適應症及葡萄膜炎適應症)累計研發投入約為人民幣2.67億元(未經審計)。
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