邁博藥業-B(02181.HK):已向國家藥監局提交類風濕性關節炎新藥上市申請
格隆匯12月30日丨邁博藥業-B(02181.HK)宣佈,公司已向國家藥監局提交CMAB008,是基於英夫利昔單抗的一種重組抗TNF-alpha嵌合單克隆抗體,的新藥上市申請。
CMAB008(英夫利昔單抗)是公司基於英夫利昔單抗的全新候選藥物,用於治療中重度活動期類風濕性關節炎。其為首個獲國家藥監局批准由一家中國本土公司在中國進行臨牀試驗的嵌合抗TNF-alpha抗體。CMAB008基於目前已上市的英夫利昔單抗藥物採用了CHO表述系統。公司認為,較目前已上市的英夫利昔單抗藥物所使用的小鼠骨瘤細胞SP2/0更安全且免疫原性更低。CMAB008使用CHO表達系統,免疫原性大幅降低。
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