復星醫藥(600196.SH):子公司斯魯利單抗注射液聯合化療等獲藥品註冊申請受理
格隆匯9月16日丨復星醫藥(600196.SH)公佈,近日,公司控股子公司復宏漢霖生物技術股份有限公司(“復宏漢霖”)及其控股子公司自主研發的斯魯利單抗注射液(即重組抗PD-1人源化單克隆抗體注射液,以下簡稱“該新藥”)聯合卡鉑和白蛋白紫杉醇一線治療局部晚期或轉移性鱗狀非小細胞肺癌獲國家藥品監督管理局藥品註冊申請審評受理。
繼2021年4月該新藥第一個適應症(即用於經標準治療失敗的、不可切除或轉移性高度微衞星不穩定型(Microsatellite Instability-High,MSI-H)實體瘤治療)的註冊申請獲國家藥監局藥品審評中心受理並納入優先審評審批程序,此次為該新藥第二個適應症(即聯合卡鉑和白蛋白紫杉醇一線治療局部晚期或轉移性鱗狀非小細胞肺癌)獲註冊申請受理。
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;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IQVIACHPA數據存在不同程度的差異),2020年度,重組抗PD-1人源化單克隆抗體注射液於中國境內銷售額約為人民幣21.91億元。
該新藥為集團自主研發的創新型治療用生物製品。截至2021年8月,集團現階段針對斯魯利單抗注射液單藥及聯合化療的累計研發投入約為人民幣11.748億元(未經審計)。
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