復星醫藥(600196.SH):擬用於治療晚期實體瘤或淋巴瘤的HLX53獲批開展臨牀試驗
格隆匯6月30日丨復星醫藥(600196.SH)公佈,近日,公司控股子公司上海復宏漢霖生物技術股份有限公司(“復宏漢霖”)收到國家藥品監督管理局關於同意其自主研發的HLX53(即抗TIGIT的Fc融合蛋白,“該新藥”)用於晚期實體瘤或淋巴瘤的治療開展臨牀試驗的批准。復宏漢霖擬於條件具備後於中國境內(不包括港澳台地區,下同)開展該新藥針對該適應症的I期臨牀試驗。
該新藥為集團自主研發的創新型抗TIGIT的Fc融合蛋白,由重鏈抗體的可變區(VHH)和野生型IgG1的Fc端組成,擬用於治療晚期實體瘤或淋巴瘤。
截至公吿日,於全球範圍內尚無抗TIGIT的藥物獲批上市。截至2022年5月,集團現階段針對該新藥累計研發投入約人民幣6490萬元(未經審計)。
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