普萊柯(603566.SH)：獲得1項新獸藥註冊證書
格隆匯7月28日丨普萊柯(603566.SH)公佈，根據《獸藥管理條例》和《獸藥註冊辦法》規定，經農業農村部審查，批准普萊柯生物工程股份有限公司與全資子公司洛陽惠中生物技術有限公司共同申報的“雞新城疫、傳染性支氣管炎、禽流感(H9亞型)、傳染性法氏囊病四聯滅活疫苗(N7a株+M41株+SZ株+rVP2蛋白)”為新獸藥，農業農村部於2021年7月27日公示了核發《新獸藥註冊證書》(農業農村部公吿第450號)事項。
該產品於2016年11月28日向農業農村部首次提交臨牀試驗申請，經後續臨牀試驗、新獸藥註冊等階段，農業農村部於2021年7月27日公吿核發新獸藥註冊證書。截至目前，該產品開發累計投入研發費用121.67萬元。
據悉，公司開發的雞新城疫、傳染性支氣管炎、禽流感(H9亞型)、傳染性法氏囊病四聯滅活疫苗(N7a株+M41株+SZ株+rVP2蛋白)產品具有以下優勢：
(1)利用反向遺傳學技術對雞新城疫病毒基因Ⅶ型強毒株進行致弱，獲得的生物安全性高的弱毒株N7a株，且保留了良好的免疫原性，製備的疫苗可顯著降低免疫雞隻強毒感染後的排毒率和載毒量；雞傳染性支氣管炎採用經典毒株M41株，免疫原性良好；通過交叉攻毒保護試驗篩選的禽流感疫苗株SZ株，抗原譜廣且對流行毒株交叉保護性好；採用重組大腸桿菌表達雞傳染性法氏囊病超強毒株VP2蛋白，疫苗對雞傳染性法氏囊病超強毒株的攻擊可提供90%以上的保護；
(2)重組菌蛋白表達量高，結合高密度發酵技術，發酵液中可溶性VP2蛋白的瓊脂擴散試驗(AGP)效價可達1∶128以上，建立的蛋白純化工藝在保證蛋白收率的同時，可有效去除98%以上的內毒素，疫苗對各日齡雞安全性良好；
(3)採用抗原濃縮與新型佐劑技術，疫苗免疫保護期長達4～6個月；
(4)一針四防，可有效減少臨牀免疫次數和雞羣應激反應。
該新獸藥證書的取得是公司持續重視科技創新、加大研發投入的結果，進一步體現了公司的創新實力以及公司在禽用基因工程多聯疫苗方面的領先地位，在有效提升公司整體競爭力的同時，推動了動保行業禽用疫苗產品的升級換代，也將為公司經營帶來新的業績增長點。
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