復宏漢霖(02696.HK):漢斯狀聯合化療一線治療既往未經治療的廣泛期小細胞肺癌(ES-SCLC)新適應症的上市註冊申請獲國家藥監局受理
格隆匯4月11日丨復宏漢霖(02696.HK)公吿，近日，公司自主開發的漢斯狀（斯魯利單抗注射液）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)新適應症的上市註冊申請(NDA)獲國家藥品監督管理局藥品審評中心受理，該適應症為漢斯狀（斯魯利單抗注射液）於中國境內（不包括港澳台地區，下同）第三項申報上市的適應症。
本次漢斯狀（斯魯利單抗注射液）新適應症的上市註冊申請(NDA)主要基於一項比較漢斯狀（斯魯利單抗注射液）聯合化療（卡鉑 － 依託泊苷）及安慰劑聯合化療（卡鉑 － 依託泊苷）在既往未接受過治療的廣泛期小細胞肺癌(ES-SCLC)患者中的隨機、雙盲、國際多中心3期臨牀研究。
研究結果顯示，漢斯狀（斯魯利單抗注射液）聯合化療對比化療顯示出明顯的總生存期(OS)改善，達到預設的優效性標準，且安全性良好，未發現新的安全性信號。
據悉，漢斯狀（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。2022年3月，NMPA已批准漢斯狀（斯魯利單抗注射液）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（MSI-H）實體瘤。2021年9月，漢斯狀（斯魯利單抗注射液）聯合化療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受理。2022年4月，漢斯狀（斯魯利單抗注射液）用於治療小細胞肺癌(SCLC)獲美國食品藥品監督管理局孤兒藥資格認定(Orphan-drugDesignation)。除已獲批上市的MSI-H實體瘤適應症外，公司亦同步就以漢斯狀（斯魯利單抗注射液）為核心的9項聯合療法在全球多個國家和地區同步開展臨牀試驗。
截至本公吿日，除公司的漢斯狀（斯魯利單抗注射液）外，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、再生元製藥(Regeneron Pharmaceuticals,Inc.)╱賽諾菲的Libtayo 等。於全球範圍內尚無PD-1產品獲批用於廣泛期小細胞肺癌(ES-SCLC)治療。於全球範圍內獲批用於廣泛期小細胞肺癌(ES-SCLC)治療的PD-L1產品有阿斯利康製藥有限公司的英飛凡和羅氏製藥的泰聖奇。根據IQVIA MIDASTM提供的資料，2021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280.8億美元。
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