邁博藥業-B(02181.HK):巴基斯坦藥品監管局批准核心產品CMAB008(注射用英夫利西單抗)的註冊
格隆匯1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)的註冊獲巴基斯坦藥品監管局批准,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。
公司已經完成的研究表明,CMAB008類停(注射用英夫利西單抗)與已經上市的其他抗TNFα藥物相比,擁有更強的TNFα親和力和糖基化特徵,起效迅速、療效持久、給藥間隔長且無超敏反應。公司完成的CMAB008類停?臨牀試驗、非臨牀比對研究、藥學比對等研究結果表明,CMAB008類停與原研英夫利西單抗在療效、安全性、藥學特徵及質量上完全一致。
英夫利西單抗已列入中國基本醫療保險藥品目錄,依照中國醫保有關規定,公司的CMAB008類停適用於英夫利西單抗醫保使用範圍,從而為患者提供一種新的更經濟實惠的選擇。
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