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邁威生物(688062.SH):阿達木單抗注射液增加適應症補充申請獲得受理

格隆匯8月17日丨邁威生物(688062.SH)公佈,近日,邁威(上海)生物科技股份有限公司與上海君實生物醫藥科技股份有限公司(簡稱“君實生物”)合作開發的阿達木單抗注射液(邁威生物項目代碼:9MW0113,君實生物項目代碼:UBP1211,商品名:君邁康®)增加用於治療克羅恩病、葡萄膜炎、多關節型幼年特發性關節炎、兒童斑塊狀銀屑病、兒童克羅恩病適應症的補充申請獲得受理。

腫瘤壞死因子(TNF-α)由巨噬細胞、肥大細胞和被激活的Th細胞分泌,為炎症反應的強效誘導劑和先天免疫的關鍵調節器,在多種炎症的發生和發展中處於核心地位。TNF-α和TNF-α受體結合可誘導炎症反應,現已證明,類風濕關節炎、銀屑病、克羅恩病、強直性脊柱炎等多種自身免疫性疾病與TNF-α密切相關。抗TNF-α單克隆抗體可結合TNF-α受體,降低TNF-α激活的免疫應答,從而阻止炎症的發生。抗TNF-α單克隆抗體是一種治療免疫介導的炎症性疾病的新一代療法,具備療效高、安全性高且給藥方便的特點。君邁康®曾獲得“十二五”國家“重大新藥創制”科技重大專項支持。此前,君邁康?已獲國家藥監局批准的適應症包括類風濕關節炎、強直性脊柱炎及銀屑病。

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