復星醫藥(600196.SH)：漢斯狀®聯合卡鉑和依託泊苷一線治療既往未經治療的廣泛期小細胞肺癌獲藥品註冊申請受理
格隆匯4月11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，商品名：漢斯狀®；“該新藥”)聯合卡鉑和依託泊苷一線治療既往未經治療的廣泛期小細胞肺癌(ES-SCLC)獲國家藥品監督管理局(“國家藥監局”)藥品註冊申請受理。
該新藥為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卡鉑和依託泊苷一線治療既往未經治療的廣泛期小細胞肺癌(ES-SCLC)的上市註冊申請均已獲國家藥監局受理。
截至公吿日，除復宏漢霖的漢斯狀®外，於中國境內(不包括港澳台，下同)上市的重組抗PD-1人源化單克隆抗體注射液包括蘇州盛迪亞生物醫藥有限公司的艾瑞卡®、信達生物製藥(蘇州)有限公司的達伯舒®、默沙東製藥有限公司的可瑞達®等。根據IQVIA CHPA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IQVIA CHPA數據存在不同程度的差異)，2021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人民幣47.65億元。
截至2022年2月，集團現階段針對此次獲受理聯合療法的累計研發投入約人民幣30999萬元(未經審計)。
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