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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 07-07 20:45

格隆匯 7 月 7日丨億帆醫藥(002019.SZ)披露控股公司在研產品F-627二個國際III關鍵性試驗結果進展,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必要條件,公司根據美國FDA法規新指導原則進行05試驗有關抗藥抗體的篩選、滴度及中和抗體檢測截止報告披露日,公司完成了05試驗有關免疫原性中和抗體檢測,結果為陰性標誌着藥物相關抗體

藥物免疫原性可能引發藥物有效性安全性擔憂,所以根據FDAF-627免疫原性進行分析。FDANeulasta生物類似審批材料可以發現,FDA要求申辦單位使用先進敏感經過驗證方法藥物抗藥抗體進行分析,因此每個產品抗體發生率方法不同不同,只要受試產生抗體中和活性,説明藥物安全性得到保證本研究F-627197受試者F-627G-CSF中和抗體檢測結果均為陰性證實F-627作為單一治療藥物安全性。

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部完成在研項目F-627國內開展I期、II期及III期臨試驗,並達到臨牀試驗預設目標

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