康諾亞-B(02162.HK):CMG901治療胃癌及胃食管結合部腺癌獲FDA孤兒藥資格認定
格隆匯4月11日丨康諾亞-B(02162.HK)發佈公吿,其在研新藥CMG901(“Claudin 18.2抗體偶聯藥物”)用於治療胃癌及胃食管結合部腺癌已於近日獲美國食品藥品監督管理局(“FDA”)孤兒藥資格認定(Orphan-drug Designation)。此前,集團已於2021年3月就CMG901在美國進行胃癌及胃食管結合部腺癌的臨牀試驗獲得FDA臨牀試驗申請批准。
根據披露,CMG901是靶向Claudin 18.2的抗體偶聯藥物,含Claudin 18.2特異性抗體、可裂解連接子及毒性載荷一甲基澳瑞他汀E(MMAE),其為首個在中國及美國均取得臨牀試驗申請批准的Claudin 18.2抗體偶聯藥物。Claudin 18.2特異性高表達於胃癌、胰腺癌及其他實體瘤中,使其成為癌症治療的理想靶點。集團目前正在實體瘤患者中處於CMG901的劑量遞增階段,以評估CMG901安全性和耐受性。預計2022年第二季度初,集團將在中國啟動的劑量拓展階段。
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