復宏漢霖(02696.HK)創新型生物藥HLX07已於中國境內完成1b/2期臨床研究
復宏漢霖(02696.HK)公布,旗下藥物HLX07(重組抗EGFR人源化單克隆抗體注射液)聯合化療已於中國境內(除港澳台地區,下同)完成1b/2期臨床研究,其在一項於晚期實體瘤患者中開展的1b/2期臨床研究中展現了良好的安全性及耐受性。
HLX07為公司自主研發的針對EGFR靶點的創新型生物藥,計劃用於晚期實體瘤治療。HLX07已於中國台灣地區完成1a期臨床試驗,並於中國境內完成1b/2期臨床試驗。漢斯狀(斯魯利單抗注射液)聯合HLX07用於頭頸部鱗狀細胞癌(HNSCC)、鱗狀非小細胞肺癌(sqNSCLC)等多種實體瘤治療的2期臨床試驗於中國境內在開展中。另外,漢斯狀(斯魯利單抗注射液)聯合HLX07以及聯合漢貝泰(貝伐珠單抗注射液)一線治療不可切除或轉移性肝細胞癌(HCC)的2期臨床試驗申請已獲國家藥品監督管理局批准,相關臨床試驗擬於近期在中國境內開展。2022年9月,HLX07用於局部晚期或轉移性皮膚鱗狀細胞癌(CSCC)治療的臨床試驗申請獲美國食品藥品管理局(FDA)批准。
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