复星医药(600196.SH):重组抗CD73全人源单抗注射液在美获批临床试验
格隆汇5月31日丨复星医药(600196.SH)宣布,近日,公司控股子公司Hengenix Biotech收到美国FDA关于同意重组抗CD73全人源单克隆抗体注射液(即HLX23)用于晚期实体瘤治疗进行临床试验的函(IND编号:153041)。Hengenix Biotech拟于条件具备后于美国进行该新药的临床试验。
该新药为集团自主研发的抗CD73(胞外-5'-核苷酸酶)创新型全人源IgG2单克隆抗体药物,拟用于晚期实体瘤治疗(包括黑色素瘤、非小细胞肺癌、肝细胞癌等)。截至该公告日,全球范围内尚无靶向CD73的单克隆抗体药品上市。
截至2021年4月,集团现阶段针对该新药累计研发投入约为人民币6293万元(未经审计)。
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