步長製藥(603858.SH):“重組抗腫瘤壞死因子-α(TNF-α)全人源單克隆抗體注射液”正式開展III期臨牀試驗
格隆匯 8 月 5日丨步長製藥(603858.SH)公佈,近日,公司全資子公司山東丹紅製藥有限公司研製的“重組抗腫瘤壞死因子-α(TNF-α)全人源單克隆抗體注射液”通過中山大學附屬第三醫院醫學倫理委員會臨牀試驗倫理審批,獲得倫理審查批件,正式開展III期臨牀試驗。
原研藥阿達木單抗注射液,商品名修美樂®(Humira®)是艾伯維公司研發的抗TNF-α全人源單克隆抗體藥物,主要用於類風濕關節炎、強直性脊柱炎等自身免疫性疾病的治療。該藥於2002年獲美國FDA批准上市,並於2010年2月在中國批准上市。根據科睿唯安數據庫顯示,Humira® 2019年全球銷售額約196億美元。
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