創勝集團-B(06628.HK)治療胃癌藥物獲美國批准開展全球III期關鍵性試驗
創勝集團-B(06628.HK)公布,美國食品和藥品管理局(FDA)已批准公司開展Osemitamab (TST001)聯合納武利尤單抗及化療作為HER2陰性、CLDN18.2表達局部晚期或轉移性胃癌或胃食管結合部腺癌(G/GEJ)患者一線治療的TranStar 301全球III期關鍵性試驗。
Osemitamab(TST001)是第二代靶向CLDN18.2的人源化抗體,具有改善的CLDN18.2結合親和力和增強的抗體依賴性細胞毒性(「ADCC」)。其在具有廣泛CLDN18.2表達的臨床前腫瘤模型中顯示出抗腫瘤活性。
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