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復星醫藥(600196.SH):復宏漢霖的漢斯狀®聯合卡鉑和依託泊苷適用於廣泛期小細胞肺癌(ES-SCLC)的一線治療的上市註冊申請獲批

格隆匯1月17日丨復星醫藥(600196.SH)公佈,近日,上海復星醫藥(集團)股份有限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(以下合稱“復宏漢霖”)自主研發的漢斯狀®(即斯魯利單抗注射液,簡稱“該藥品”)聯合卡鉑和依託泊苷適用於廣泛期小細胞肺癌(ES-SCLC)的一線治療的上市註冊申請獲國家藥品監督管理局批准。

該藥品為集團(即公司及控股子公司/單位,下同)自主研發的創新型抗PD-1單抗,擬用於多種實體瘤治療。截至2022年12月,集團現階段針對該藥品(單藥及各項聯合化療)的累計研發投入約為人民幣20.3989億元(未經審計)。

該藥品為全球範圍內首個獲批用於一線治療廣泛期小細胞肺癌(ES-SCLC)的靶向PD-1的單抗藥品,此次獲批註冊可以為廣泛期小細胞肺癌(ES-SCLC)患者帶來更多的治療選擇。

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