復星醫藥(02196.HK)控股子公司獲藥品註冊申請受理
格隆匯9月16日丨復星醫藥(02196.HK)發佈公吿,近日,公司控股子公司復宏漢霖及其控股子公司研製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監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。
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