復宏漢霖(02696.HK):注射用HLX42(靶向EGFR抗體-新型DNA拓撲異構酶I抑制劑偶聯藥物)治療晚期/轉移性實體瘤的臨牀試驗申請獲國家藥品監督管理局批准
格隆匯10月27日丨復宏漢霖(02696.HK)公吿,近日,注射用HLX42(靶向EGFR抗體-新型DNA拓撲異構酶I抑制劑偶聯藥物)("HLX42")用於治療晚期/轉移性實體瘤的1期臨牀試驗申請獲國家藥品監督管理局批准。
HLX42是由公司利用於2022年11月自蘇州宜聯生物醫藥有限公司許可引進的新型DNA拓撲異構酶I抑制劑小分子毒素-肽鏈連接子與公司自主研發的靶向EGFR的抗體進行偶聯開發的靶向EGFR的抗體偶聯藥物,擬用於晚期/轉移性實體瘤的治療。HLX42可與人EGFR抗原靶點特異性結合,在腫瘤中釋放攜帶的小分子毒素,從而發揮腫瘤殺傷作用。非臨牀藥理學研究、藥代動力學研究及安全性評價表明,HLX42能夠抑制腫瘤生長,且具有良好的安全性。
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