復星醫藥(600196.SH):斯魯利單抗注射液獲美國FDA孤兒藥資格認定
格隆匯4月7日丨復星醫藥(600196.SH)公佈,近日,公司控股子公司Hengenix Biotech,Inc.(繫上海復宏漢霖生物技術股份有限公司的控股子公司)收到美國FDA關於斯魯利單抗注射液(即重組抗PD-1人源化單克隆抗體注射液,中國境內商品名:漢斯狀®)用於小細胞肺癌(SCLC)治療獲得孤兒藥資格認定的函。
該新藥為本集團自主研發的創新型治療用生物製品,擬用於多種實體瘤治療。2022年3月,該新藥用於治療經標準治療失敗的、不可切除或轉移性微衞星高度不穩定型(MSI-H)實體瘤的上市註冊申請獲國家藥品監督管理局附條件批准。
除前述已獲批上市用於MSI-H實體瘤適應症外,截至本公吿日,以該新藥為核心的9項聯合療法正在全球多個國家和地區開展臨牀試驗,其中:該新藥聯合化療一線治療局部晚期或轉移性鱗狀非小細胞肺癌、以及該新藥聯合化療治療既往未接受過治療的廣泛期小細胞肺癌(ES-SCLC)均處於國際多中心III期臨牀試驗中。
截至本公吿日,除本集團的漢斯狀®外,於全球範圍內上市的靶向PD-1的單克隆抗體藥品主要包括默沙東製藥有限公司的可瑞達®、美國百時美施貴寶公司的歐狄沃®、再生元製藥公司(Regeneron Pharmaceuticals,Inc.)/賽諾菲的Libtayo®等。根據IQVIAMIDASTM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),2021年度,靶向PD-1的單克隆抗體藥品於全球範圍內的銷售額約為280.80億美元。
截至2022年2月,本集團現階段針對該新藥聯合化療(用於小細胞肺癌(SCLC)治療)的累計研發投入約為人民幣3.1億元(未經審計)。
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