嘉和生物-B(06998.HK):國家藥監局受理GB242英夫利西單抗(類克)生物類似藥候選產品新藥上市申請
格隆匯 11 月 3日丨嘉和生物-B(06998.HK)公告,董事會欣然宣佈GB242英夫利西單抗生物類似藥的新藥上市申請已經正式獲中國國家藥品監督管理局(NMPA)受理。
集團於2020年10月27日遞交新藥上市申請,並於2020年11月3日獲得中國國家藥品監督管理局受理。新藥上市申請是基於一項在中國的多中心、隨機、雙盲、平行對照的三期臨牀試驗,用於評估GB242對比類克(英夫利西單抗類)與甲氨蝶呤組合按3mg/kg劑量水平靜脈注射治療類風濕性關節炎成人患者的安全性及療效。
GB242是英夫利西單抗的生物類似藥候選產品,英夫利西單抗在中國以商品類克出售。與英夫利西單抗類似,GB242能夠以低劑量結合腫瘤壞死因子-α(TNF-α),從而抑制人體對TNF-α的自然反應並改善炎症反應及自身免疫性疾病。
該三期研究招募了570名患者,主要研究終點為30周時ACR20的等效療效。基於研究結果,GB242與類克療效相當,在免疫原性方面與類克在臨牀上無顯著差別。
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