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韩国MFDS批准抗COVID-19单克隆抗体CT-P59的II / III期关键试验

2020-09-18 Allan MedSci原创

Covid-19CT-P59韩国MFDS
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Celltrion集团今天宣布，韩国食品药品安全部（MFDS）批准了该公司的研究性新药（IND）申请。

Celltrion集团今天宣布，韩国食品药品安全部（MFDS）批准了该公司的研究性新药（IND）申请，允许开展抗COVID-19单克隆抗体CT-P59治疗COVID-19患者的II / III期关键临床试验。这项全球性试验将评估CT-P59在轻度至中度COVID-19患者中的安全性和有效性。Celltrion有望在今年年底之前获得主要结果。

Celltrion已在包括韩国、美国和西班牙在内的6个国家/地区提交了IND，并计划招募来自12个国家/地区的1,000多名患者。该公司希望能够根据关键试验的结果申请紧急使用授权（EUA）。

Celltrion已开始制造CT-P59，并计划提高制造能力，以满足当前全球对抗COVID-19单克隆抗体药物的需求。

Celltrion高级执行副总裁Sang Joon Lee博士说：“鉴于COVID-19对生命的重大威胁，迫切需要找到可以帮助我们应对大流行的治疗方法。CT-P59的全球II / III期关键性临床试验的启动是向前迈出的重要一步”。

 

原始出处：

https://www.firstwordpharma.com/node/1758455?tsid=4

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    2021-06-04 aids221

    #克隆#

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    2020-11-24 juliusluan78

    #III#

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    2020-09-21 14818eb4m67暂无昵称

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    2020-09-20 智智灵药

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