復星醫藥(02196.HK)子公司獲藥品註冊申請受理
格隆匯4月11日丨復星醫藥(02196.HK)公吿,近日,上海復星醫藥(集團)股份有限公司(以下簡稱“公司”)控股子公司復宏漢霖生物技術股份有限公司(以下簡稱“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;以下簡稱“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(以下簡稱“國家藥監局”)藥品註冊申請受理。
該新藥為集團(即公司及控股子公司/單位,下同)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。
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