港股异动 | 复宏汉霖(02696)现涨超4% 帕妥珠单抗生物类似药HLX11的生物制品许可申请获FDA受理

智通财经
04 Feb

智通财经APP获悉,复宏汉霖(02696)现涨超4%,截至发稿,涨4.24%,报17.7港元,成交额365.55万港元。

消息面上,复宏汉霖公告,公司自主研发的Perjeta (帕妥珠单抗)生物类似药候选药HLX11的生物制品许可申请(BLA)获美国食品药品管理局(FDA)受理。据悉,HLX11是公司自主研发的帕妥珠单抗生物类似药,拟用于HER2阳性早期乳腺癌的新辅助/辅助治疗、HER2阳性转移性乳腺癌的治疗及与原研药药品标签相符的其他适应症。

值得注意的是,1月26日,复宏汉霖宣布,公司两项创新药抗PD-1单抗H药汉斯状和创新型抗HER2单抗HLX22的最新研究结果在2025年美国临床肿瘤学会胃肠道肿瘤研讨会(ASCOGI)上以壁报形式发布。据悉,H药汉斯状为复宏汉霖自主研发的重组人源化抗PD-1单抗注射液,也是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗;HLX22为复宏汉霖自AbClon,Inc.许可引进、并后续自主研发的靶向HER2的创新型单克隆抗体。

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