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复宏汉霖-B(02696.HK):ACE2-Fc受体融合蛋白HLX71的临床试验申请获美国FDA批准
格隆汇 11-06 17:12

格隆汇 11 月 6日丨复宏汉霖-B(02696.HK)宣布,近日,公司控股子公司Hengenixbiotech, Inc.收到美国食品药品管理局(FDA)关于同意ACE2-Fc受体融合蛋白HLX71("HLX71")用于治疗新型冠状病毒肺炎(COVID-19)进行临床试验的函。

HLX71是公司自主研发的、C末端带有IgG1 Fc的重组人血管紧张素转换酶2(human Angiotensin converting enzyme 2,hACE2)融合蛋白,拟用于治疗新型冠状病毒肺炎(COVID-19)。其作用机理为HLX71可以竞争性地与SARSCoV-2表面的Spike蛋白结合,从而抑制病毒与宿主细胞表面的血管紧张素转换酶2(Angiotensin converting enzyme 2,ACE2)结合,最终达到抑制病毒感染的效果。临床前药理学研究、药代动力学研究及安全性评价证明,HLX71能够显着抑制SARS-CoV-2病毒感染,具有良好的安全性,可以用于开展后续的人体临床试验。

截至公告日,于全球范围内尚无同类针对新型冠状病毒肺炎的受体融合蛋白药物获批上市。

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