君实生物(01877.HK):新冠双抗体疗法获得FDA紧急使用授权
君实生物(01877.HK)公布,礼来制药(LLY.US)在研抗体药物Etesevimab 1,400 mg及Bamlanivimab 700 mg双抗体疗法,已获得美国食品药品监督管理局(FDA)授予紧急使用授权。
该疗法被授予用於治疗伴有进展为重度COVID-19及/或住院风险的12岁及以上轻中度COVID-19患者,患者在确诊及出现症状後10天内应尽快通过单次静脉注射进行该双抗体治疗。
此外,FDA已批准将Bamlanivimab单药,以及Etesevimab及Bamlanivimab双抗体疗法的输注时间分别缩短至16分钟或21分钟,与早前批准的60分钟时间减少。
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