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嘉和生物-B(06998.HK):国家药监局受理GB242英夫利西单抗(类克)生物类似药候选产品新药上市申请
格隆汇 11-03 23:01

格隆汇 11 月 3日丨嘉和生物-B(06998.HK)公告,董事会欣然宣布GB242英夫利西单抗生物类似药的新药上市申请已经正式获中国国家药品监督管理局(NMPA)受理。

集团于2020年10月27日递交新药上市申请,并于2020年11月3日获得中国国家药品监督管理局受理。新药上市申请是基于一项在中国的多中心、随机、双盲、平行对照的三期临床试验,用于评估GB242对比类克(英夫利西单抗类)与甲氨蝶呤组合按3mg/kg剂量水平静脉注射治疗类风湿性关节炎成人患者的安全性及疗效。

GB242是英夫利西单抗的生物类似药候选产品,英夫利西单抗在中国以商品类克出售。与英夫利西单抗类似,GB242能够以低剂量结合肿瘤坏死因子-α(TNF-α),从而抑制人体对TNF-α的自然反应并改善炎症反应及自身免疫性疾病。

该三期研究招募了570名患者,主要研究终点为30周时ACR20的等效疗效。基于研究结果,GB242与类克疗效相当,在免疫原性方面与类克在临床上无显著差别。

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