復宏漢霖(02696.HK)斯魯利單抗注射液通過GMP符合性現場檢查
格隆匯10月11日丨復宏漢霖(02696.HK)公吿,近日,公司全資子公司上海復宏漢霖生物製藥有限公司收到上海市藥品監督管理局頒發的《藥品生產現場檢查結果吿知書》,公司位於上海市徐彙區的生物藥生產基地順利通過上海市藥品監督管理局針對斯魯利單抗注射液(重組抗PD-1人源化單克隆抗體注射液)的原液(DS)生產南線及製劑(DP)生產二線、製劑(DP)生產一線包裝區域的GMP符合性現場檢查。
斯魯利單抗注射液為公司自主開發的創新型抗PD-1單抗,計劃用於多種實體瘤治療,目前就1項單藥及以其為核心的8項聯合療法在全球多個國家和地區同步開展臨牀試驗。2021年4月,斯魯利單抗注射液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實體瘤治療的上市註冊申請(NDA)獲國家藥品監督管理局(NMPA)藥品審評中心受理並正式納入優先審評審批程序。2021年9月,斯魯利單抗注射液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(sqNSCLC)的上市註冊申請(NDA)獲NMPA藥品審評中心受理。
截至本公吿日,於全球範圍內上市的靶向PD-1的單克隆抗體藥品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、蘇州盛迪亞生物醫藥有限公司(江蘇恆瑞醫藥股份有限公司的全資子公司)的艾瑞卡等。根據IQVIAMIDASTM提供的資料,2020年度,靶向PD-1的單克隆抗體藥品於全球範圍內的銷售金額約為230.75億美元。
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