复星医药(600196.SH):抗S1全人源单克隆中和抗体HLX70用于治疗新冠病毒肺炎和新冠病毒引起的急性呼吸窘迫综合征或多重器官衰竭获美国FDA药品临床试验批准
格隆汇 10 月 8日丨复星医药(600196.SH)公布,近日,公司控股子公司Hengenix Biotech, Inc.(即控股子公司上海复宏汉霖生物技术股份有限公司之全资子公司;“Hengenix”)收到美国FDA(即美国食品药品监督管理局,下同)关于同意抗S1全人源单克隆中和抗体HLX70用于治疗新型冠状病毒肺炎和新型冠状病毒引起的急性呼吸窘迫综合征或多重器官衰竭进行临床试验的函。Hengenix拟于近期条件具备后于美国开展该新药的I期临床试验。
该新药基于复宏汉霖于2020年5月与三优生物医药(上海)有限公司、上海之江生物科技股份有限公司就全人源抗体药物用于单药或联用治疗新型冠状病毒肺炎所达成的《合作开发协议》进行研发。
该新药为靶向SARS-CoV-2病毒表面Spike蛋白受体结合区区域的全人源单克隆抗体,拟用于新型冠状病毒肺炎、新型冠状病毒引起的急性呼吸窘迫综合征或多重器官衰竭的治疗。
截至公告日,于全球范围内尚无用于治疗新型冠状病毒肺炎的全人源抗体药物获得上市批准。
截至2020年8月,集团现阶段针对该新药累计研发投入约人民币1520万元(未经审计)。
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