億帆醫藥(002019.SZ):完成了05試驗有關免疫原性的中和抗體檢測 結果為陰性
格隆匯 7 月 7日丨億帆醫藥(002019.SZ)披露控股子公司在研產品F-627第二個國際III期關鍵性臨牀試驗結果的進展,根據生物藥新藥註冊申報相關管理辦法,免疫原性抗體檢測是申報BLA(生物藥品新藥註冊申請)的必要條件,公司根據美國FDA法規及最新指導原則進行05試驗有關抗藥抗體的篩選、確證、滴度及中和抗體檢測,截止報告披露日,公司完成了05試驗有關免疫原性的中和抗體檢測,結果為陰性,標誌着無藥物相關的抗體產生。
藥物的免疫原性可能引發對藥物有效性和安全性的擔憂,所以根據FDA的要求對F-627的免疫原性進行了分析。從FDA對Neulasta的生物類似物的審批材料中可以發現,FDA要求申辦單位使用最先進最敏感的經過驗證的方法對藥物的抗藥抗體進行分析,因此每個產品的抗體發生率會因方法的不同而不同,但只要受試者產生的抗體無中和活性,就説明藥物的安全性得到了保證。本研究中F-627治療組197例受試者的抗F-627和抗G-CSF的中和抗體檢測結果均為陰性,證實了F-627作為單一治療藥物的安全性。
此次完成05試驗有關免疫原性的中和抗體檢測,標誌着有關F-62705試驗圓滿達到臨牀試驗預設目標,試驗取得了圓滿成功;同時也標誌着上海健能隆全部完成在研項目F-627國內外開展的I期、II期及III期臨牀試驗,並達到臨牀試驗預設目標。
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