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嘉和生物(06998.HK)生物類似藥遞交新藥申請
阿思達克 11-02 18:00
嘉和生物(06998.HK)公布,已就GB242英夫利西單抗生物類似藥向國家藥品監督管理局遞交新藥申請。

新藥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患者的安全性及療效。類克在靶向TNF-α藥物中具有中國批准的最廣泛的適應症,包括類風濕性關節炎(RA)、強直性脊柱炎(AS)、銀屑病關節炎(PsA)、克羅恩病(CD)及潰瘍性結腸炎(UC)。

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