復宏漢霖(02696.HK):HLX10聯合HLX07用於HNSCC治療的2期臨牀研究於中國大陸完成首例患者給藥
格隆匯 7 月 29日丨復宏漢霖-B(02696.HK)發佈公告,今日,公司重組抗PD-1人源化單克隆抗體注射液(“HLX10”)聯合重組抗EGFR人源化單克隆抗體注射液(“HLX07”)用於復發或轉移性頭頸部鱗狀細胞癌(HNSCC)治療的2期臨牀研究於中國大陸完成首例患者給藥。
該研究為一項評價HLX10聯合HLX07治療晚期複發性或轉移性頭頸部腫瘤患者的臨牀療效及安全性的開放性、2期臨牀試驗。試驗主要目的是評價 HLX10和HLX07聯合治療晚期頭頸部鱗狀細胞癌的第16周客觀緩解率及安全性。其次旨在評價其他療效終點、免疫原性與藥代動力學特徵。探索性目的包括監別治療反應和╱或耐藥性的生物標誌物。
HLX10為公司自主研發的創新型生物藥,擬用於實體瘤治療,目前正進一步探索用於慢性B型肝炎(即慢性乙型肝炎)治療的可能性。HLX07為公司自主研發的針對EGFR靶點的改良型創新生物藥,有望用於結直腸癌、鼻咽癌等多種實體瘤適應症治療。截至該公告日,於中國大陸尚無同類聯合療法獲國家藥品監督管理局上市批准。
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