瑞普生物(300119.SZ):狂犬病滅活疫苗變更註冊獲批
格隆匯2月14日丨瑞普生物(300119.SZ)公佈,公司控股子公司廣州市華南農大生物藥品有限公司(“華南生物”)提交的狂犬病滅活疫苗(dG株)獸藥產品變更註冊申請,近日獲得農業農村部批准。
狂犬病是由狂犬病毒所致的急性傳染病,人獸共患,多見於犬、貓等動物,主要在動物間傳播,人多因被病獸咬傷而感染,目前已成為危害我國人口健康與公共衞生安全的重大傳染病。通過預防犬、貓等動物的狂犬病,從源頭上控制狂犬病對人的傳播,是防治人類感染狂犬病的重要措施之一。狂犬病滅活疫苗(dG株)是國內外首創的狂犬病基因工程滅活疫苗,以反向遺傳操作技術獲得的攜帶雙G基因的重組狂犬病毒dG株為疫苗毒株,該毒株具有免疫原性好、細胞滴度高、致病性低等特點。通過在狂犬病毒基因組中增加免疫原基因,大幅提高病毒增殖效率,提升免疫原性,疫苗在生產工藝上無需濃縮、純化,從而大幅降低成本。疫苗注射副反應小,一次免疫,保護期長達12個月,免疫保護效果顯著。
狂犬病滅活疫苗(dG株)的有效期從12個月變更為24個月,表明產品的生產工藝已經達到國內領先水平,疫苗有效期的延長,將有利於滿足政府招標採購指標的需求,為人畜共患狂犬病的防控提供產品支持;有利於擴大市場份額,為狂犬病疫苗成為國內一流產品提供技術保障;有利於寵物醫院和普通用户的儲存使用;有利於車間生產線進一步擴大產能,提高生產效率,為社會提供更多更好的產品。
狂犬病滅活疫苗(dG株)是公司在寵物醫藥領域取得的首個寵物用疫苗,與公司已有的寵物藥品、生物製劑初步形成全面的寵物醫藥產品體系。另外,瑞派寵物醫院管理股份有限公司快速發展,中高端寵物醫院數量迅速增加,已經成為國內寵物連鎖診療領域一線品牌。公司作為瑞派寵物的股東之一,未來將充分結合瑞派寵物的市場渠道優勢,發揮協同效應,大力拓展寵物業務。
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