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創勝集團(06628.HK)治療癌症藥物獲中韓批准開展III期臨床試驗
阿思達克 07-07 12:27
創勝集團(06628.HK)公布,已獲得中國藥監局藥品審評中心(CDE)和韓國食品藥品安全部(MFDS)批准,在HER2陰性、CLDN18.2表達的一線局部晚期或轉移性胃或胃食管連接部(G/GEJ)腺癌患者中,開展Osemitamab(TST001)聯合納武利尤單抗與化療的TranStar 301全球III期關鍵性臨床試驗。此外,集團正在與歐盟和FDA進行監管互動。 TranStar301是一項全球範圍內進行的隨機、雙盲、安慰劑對照的III期臨床試驗,旨在評估Osemitamab(TST001)聯合納武利尤單抗與化療在HER2陰性、CLDN18.2表達的局部晚期或轉移性胃╱胃食管連接部腺癌患者中的一線治療效果。
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