復宏漢霖(02696.HK)：HLX26聯合漢斯狀®用於治療晚期轉移性實體瘤或淋巴瘤的臨牀試驗申請獲國家藥品監督管理局批准
格隆匯4月28日丨復宏漢霖(02696.HK)公吿，近日，公司自主研發的HLX26(重組抗LAG-3人源化單克隆抗體注射液)("HLX26")聯合漢斯狀®(斯魯利單抗注射液)("漢斯狀")用於治療晚期╱轉移性實體瘤或淋巴瘤的1期臨牀試驗申請獲國家藥品監督管理局批准。公司擬於條件具備後於中國境內(不包括港澳台地區，下同)開展1期臨牀試驗。
HLX26為公司自主研發的靶向淋巴細胞活化基因3(Lymphocyte-activationgene 3,"LAG-3")胞外結構域的創新型人源化單抗，計劃用於實體瘤及淋巴瘤治療。2021年10月，HLX26用於實體瘤及淋巴瘤治療的1期臨牀研究於中國境內完成首例受試者給藥。HLX26通過阻斷LAG-3與其配體的相互作用，從而阻斷LAG-3介導抑制T細胞功能的信號通路，恢復T細胞IL-2、IFN-γ等細胞因子的釋放，通過與漢斯狀的聯用，在腫瘤微環境中阻斷免疫逃逸達到抑制腫瘤的目的。臨牀前體內外藥效學研究結果顯示，HLX26與漢斯狀聯合用藥恢復T細胞殺傷功能具有協同效應，顯示出較為顯着的抗腫瘤活性。
漢斯狀為公司自主研發的創新型抗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NMPA受理。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。
截至公吿日，於中國境內尚無同類聯合用藥治療方案獲NMPA上市批准；於全球範圍內上市的靶向LAG-3聯合靶向PD-1的複方製劑有百時美施貴寶公司的OPDUALAG，於2022年3月獲美國食品藥品監督管理局批准上市。
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