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邁博藥業-B(02181.HK):祕魯衞生部批准核心產品CMAB008(注射用英夫利西單抗)的上市註冊申請
格隆匯 07-02 18:14

格隆匯7月2日丨邁博藥業-B(02181.HK)公吿,近日,公司核心產品之一,自主開發的重組抗腫瘤壞死因子α(TNFα)人鼠嵌合單克隆抗體CMAB008類停(注射用英夫利西單抗)的上市註冊申請獲祕魯衞生部批准,用於治療:(i)成人潰瘍性結腸炎;(ii)強直性脊柱炎;(iii)類風濕關節炎;(iv)成人及6歲以上兒童克羅恩病;(v)瘻管性克羅恩病;及(vi)銀屑病。

CMAB008類停為首個獲准上市的中國生產的英夫利西單抗,是公司自主開發的單克隆抗體生物類似藥,亦是公司核心產品之一。CMAB008類停使用中國倉鼠卵巢細胞表達系統,是一種以TNFα為靶點的單克隆抗體,能夠特異性地結合TNFα並阻斷其引起的炎症級聯反應;主要用於成人潰瘍性結腸炎、強直性脊柱炎、成人及6歲以上兒童克羅恩病、瘻管性克羅恩病、類風濕關節炎及銀屑病的治療。

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