創勝集團-B(06628.HK)附屬通過歐盟質量受權人審計
創勝集團-B(06628.HK)公佈,公司全資附屬奕安濟世已於今年4月13日順利通過歐盟質量受權人審計,QP認證聲明已於今日(21日)簽發。
集團指,TST001爲全球正在開發的針對Claudin18.2的最先進的抗體療法之一,該審計是TST001一個包括歐盟地區在內的全球三期臨牀試驗申請準備工作中重要的一部份,以及未來TST001的全球商業化。
TST001是一種高親和力人源化抗Claudin18.2的單克隆抗體,具有增強的抗體依賴性細胞毒性及補體依賴性細胞毒性活性,並於腫瘤異種移植模型中顯示出強大的抗腫瘤活性。TST001是全球範圍內開發的第二款Claudin18.2靶向抗體治療候選藥物。
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