復星醫藥(02196.HK):控股子公司獲美國FDA藥品臨牀試驗批準
格隆匯8月7日丨復星醫藥(02196.HK)公告,近日,上海復星醫藥(集團)股份有限公司(以下簡稱“本公司”)控股子公司上海復宏漢霖生物技術股份有限公司及其控股子公司(以下合稱“復宏漢霖”)獲美國FDA(即美國食品藥品監督管理局)批準開展注射用HLX43(即靶向PD-L1抗體偶聯藥物,以下簡稱“該新藥”)用於治療胸腺癌(TC)的I期臨牀試驗。復宏漢霖擬於條件具備後於澳大利亞、日本、美國等地開展該適應症的全球多中心臨牀研究。
該新藥爲復宏漢霖將許可引進的新型DNA拓撲異構酶I抑制劑小分子毒素-肽鏈連接子與復宏漢霖自主研發的靶向PD-L1的抗體進行偶聯開發的靶向PD-L1的抗體偶聯藥物(ADC),擬用於晚期/轉移性實體瘤的治療。
截至2025年6月,集團(即公司及控股子公司/單位)現階段針對該新藥的累計研發投入約爲人民幣1.82億元(未經審計,單藥)。截至本公告日期,全球範圍內尚無靶向PD-L1的抗體偶聯藥物獲批上市。
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