普萊柯(603566.SH):參股公司獲獸藥產品批准文號 涉豬口蹄疫O型、A型二價滅活疫苗(OHM/02株+AKT-Ⅲ株)
格隆匯3月16日丨普萊柯(603566.SH)公佈,根據《獸藥管理條例》和《獸藥產品批准文號管理辦法》等有關規定,經農業農村部審查,准予公司參股公司中普生物製藥有限公司(“中普生物”)生產豬口蹄疫O型、A型二價滅活疫苗(OHM/02株+AKT-Ⅲ株)。
獸藥產品批准文號:獸藥生字250047544;)通用名稱:豬口蹄疫O型、A型二價滅活疫苗(OHM/02株+AKT-
Ⅲ株);含量規格:20ml/瓶;50ml/瓶;100ml/瓶;批文有效期:2020-03-04至2020-11-30。
中普生物與天康生物股份有限公司、新疆畜牧科學院獸醫研究所(新疆畜牧科學院動物臨牀醫學研究中心)、楊凌金海生物技術有限公司聯合開展該產品的新獸藥註冊申報相關工作,並獲得三類新獸藥註冊證書。截至目前中普生物用於開發該產品的研發費用為3200萬元。
目前,中普生物已按照《獸藥管理條例》、《獸藥產品批准文號管理辦法》的要求,開展產品文號申請及報審相關工作,並取得獸藥產品批准文號,新獸藥產品具備上市銷售條件。
該產品能夠同時預防豬的O型和A型口蹄疫,是預防豬口蹄疫的重要疫苗產品,符合口蹄疫疫病防控形勢和防疫需求。此次獲得該獸藥產品批准文號將進一步豐富中普生物的產品序列,對提升市場競爭力產生積極影響。
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