智通财经APP讯，复星医药(600196.SH)发布公告，近日，公司控股子公司上海复宏汉霖生物技术股份有限公司及其控股子公司(以下合称“复宏汉霖”)收到国家药品监督管理局关于同意HLX05-N(即重组抗EGFR人鼠嵌合单克隆抗体注射液)用于转移性结直肠癌治疗开展Ⅰ期临床试验的批准。复宏汉霖拟于条件具备后就该药品开展相关临床研究。
HLX05-N系集团(即公司及控股子公司/单位，下同)自主研发的西妥昔单抗注射液生物类似药，拟用于转移性结直肠癌及头颈部鳞状细胞癌治疗。截至2026年3月，集团现阶段针对HLX05-N的累计研发投入约为人民币0.54亿元（未经审计）。
根据IQVIA MIDASTM最新数据，2025年，西妥昔单抗注射液于全球范围的销售额约为16.58亿美元。
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