智通财经APP讯，复宏汉霖(02696)公布，近日，HLX22(重组人源化抗HER2单克隆抗体注射液)(HLX22)联合曲妥珠单抗和化疗(XELOX)对比曲妥珠单抗和化疗 (XELOX)联合或不联合帕博利珠单抗一线治疗HER2阳性局部晚期或转移性胃食管交界部和胃癌的国际多中心3期临床试验申请于德国获批。公司拟于条件具备后于德国及其他欧盟国家开展临床试验。
据悉，HLX22为公司许可引进并后续自主研发的新型靶向HER2的单克隆抗体，潜在适应症包括胃癌和乳腺癌等实体瘤。2025年3月，HLX22用于治疗胃癌(GC)获美国食品药品监督管理局(FDA)孤儿药资格认定(Orphan-drug Designation)。
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