生物股份(600201.SH):布魯氏菌基因缺失活疫苗(M5–90△26株)取得新獸藥註冊證書
格隆匯2月23日丨生物股份(600201.SH)公佈,根據國家《獸藥管理條例》和《獸藥註冊辦法》規定,經農業農村部審查,批准公司全資子公司金宇保靈與中國農業科學院哈爾濱獸醫研究所、中國農業科學院蘭州獸醫研究所、哈爾濱維科生物技術有限公司、中牧實業股份有限公司、中農威特生物科技股份有限公司聯合開發的布魯氏菌基因缺失活疫苗(M5–90△26株)為新獸藥,並核發了《新獸藥註冊證書》。
作用與用途:用於預防羊布魯氏菌病。免疫期為12個月。本疫苗免疫後15~180日,用布魯氏菌bp26–iELISA法可區分本疫苗免疫與野毒感染。
布魯氏菌基因缺失活疫苗(M5–90△26株)於2016年9月獲得新獸藥臨牀試驗批文。經臨牀試驗後,金宇保靈與其他聯合開發單位開展後續新獸藥證書的註冊申報相關工作。截至目前,該疫苗累計投入研發費用約348萬元。
布魯氏菌病是由布魯氏菌引起的世界範圍分佈的人畜共患慢性傳染病。目前,我國布魯氏菌病流行的主要菌種為羊種布魯氏菌,陽性羊為布魯菌病主要傳染源,通過疫苗免疫是控制羊布魯氏菌病的有效方式。布魯氏菌基因缺失活疫苗(M5–90△26株)利用我國自行培育並得到廣泛應用的羊種布魯氏菌疫苗M5-90株,採用同源重組技術構建bp26基因缺失的M5-90△26株。同時建立了以bp26蛋白為包被抗原的bp26-iELISA檢測方法,對野生菌株和本基因缺失活疫苗感染的血清進行區分,從而達到鑑別診斷目的。M5-90△26株具有更好的安全性,不發生水平傳播,不會對其他接觸動物及周圍環境造成污染。上述疫苗具有較高的免疫保護性,羊羣接種後可極大降低布魯氏菌的感染率,為羊布魯氏菌病防控與淨化提供了重要手段。
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