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邁博藥業-B(02181.HK):核心產品CMAB009的上市註冊申請獲國家藥監局受理,用於治療轉移性結直腸癌
格隆匯 03-14 23:01

格隆匯3月14日丨邁博藥業-B(02181.HK)宣佈,近日,公司核心產品之一,CMAB009的上市註冊申請("NDA")獲中國國家藥品監督管理局("國家藥監局")受理,用於治療轉移性結直腸癌。

CMAB009為一種重組抗表皮生長因子受體("EGFR")嵌合單克隆抗體,是我們基於西妥昔單抗的全新候選藥物,與FOLFIRI聯合用於轉移性結直腸癌("mCRC")的一線治療。CMAB009是首個向國家藥監局申請NDA的用於結直腸癌治療的中國國產抗EGFR單克隆抗體藥物。CMAB009利用中國倉鼠卵巢細胞("CHO")表達系統,該系統不同於已上市的西妥昔單抗產品所使用的小鼠骨髓瘤細胞SP2/0表達系統。CMAB009的安全性及療效由兩項已完成臨牀試驗的結果所證實。根據我們的臨牀試驗結果與現時已上市的西妥昔單抗產品已公佈臨牀試驗結果的比較,CMAB009較現時已上市用於治療mCRC的西妥昔單抗藥物同樣有效且顯着降低免疫原性並減少嚴重超敏反應等不良反應的發生。CMAB009未來預計適應症有望拓展到頭頸部鱗癌等癌種。

CMAB009上市後將有望為超過100萬名中國腫瘤患者提供療效更佳的可負擔的生物特效治療藥物。

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