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”)获美国FDA(即美国食品药品监督管理局)批准开展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的Ⅰ期临床试验。复宏汉霖拟于条件具备后于美国开展该药品的相关临床研究。
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。2026年4月，该药品用于转移性结直肠癌治疗的Ⅰ期临床试验申请获中国国家药品监督管理局批准。
根据IQVIA MIDAS™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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