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瑞普生物(300119.SZ):重組犬α-干擾素(凍幹型)取得獸藥產品批准文號
格隆匯 03-18 19:07

格隆匯3月18日丨瑞普生物(300119.SZ)公佈,天津瑞普生物技術股份有限公司空港經濟區分公司近日獲得由農業農村部核發的獸藥產品批准文號。商品名稱:權幹素,通用名稱:重組犬α-干擾素(凍幹型)。

干擾素(interferon,IFN)是一種細胞因子,它是機體感染病毒時,由宿主細胞通過抗病毒應答反應而產生的一組結構類似、功能相近的低分子糖蛋白。其中α-干擾素主要通過抑制病毒複製以發揮其直接抗病毒活性,並激活和調節機體天然免疫與適應性免疫系統的細胞免疫功能。因此,病毒感染早期應用干擾素能發揮其抗病毒活性、中後期應用可發揮其免疫調節功能。

重組犬α-干擾素(凍幹型)系研究人員採用基因重組工程技術將犬α干擾素基因插入重組質粒中,構建重組的大腸桿菌菌種,經高密度蛋白表達、蛋白提取和純化、真空冷凍乾燥研製而成,是公司應用前沿生物工程技術製備的擁有自主知識產權的產品。

重組犬α-干擾素(凍幹型)項目從立項研製至獲取批文,歷經十餘年,是我國首個重組大腸桿菌表達的獸用干擾素製品。作為一種重組生化藥物,其與傳統提取類藥物相比,具有有效成分純度高、安全性好、生產性能穩定等特點。通過農業轉基因生物安全評價、多區域臨牀試驗等驗證,證明本製品對犬安全、高效,可用於早期治療犬細小病毒性腸炎等病毒感染性疾病,為寵物臨牀醫師提供了一種新的用藥選擇。重組犬α-干擾素(凍幹型)將成為公司寵物產品系列中的重要產品,對於提升寵物產品銷量有重要意義。

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