生物股份(600201.SH)子公司取得新獸藥註冊證書 涉小鵝瘟病毒滅活疫苗(TZ10株)
格隆匯3月4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揚州優邦生物藥品有限公司(“揚州優邦”)自主研發的小鵝瘟病毒滅活疫苗(TZ10株)為新獸藥，並核發了《新獸藥註冊證書》。
新獸藥名稱：小鵝瘟病毒滅活疫苗(TZ10株)；主要成分：含滅活的小鵝瘟病毒TZ10株作用與用途：用於預防小鵝瘟。通過免疫種鵝，使雛鵝獲得被動保護，免疫期為5個月。用法與用量：胸部肌肉注射。種鵝開產前5周首免，每隻1.0ml，3周後以相同劑量加強免疫一次。貯藏與有效期:2～8℃保存，有效期為12個月。
小鵝瘟病毒滅活疫苗(TZ10株)由揚州優邦獨立自主研發，於2015年獲得新獸藥臨牀試驗批文。經臨牀試驗後，揚州優邦開展後續新獸藥證書的註冊申報相關工作。截至目前，揚州優邦為該疫苗累計投入研發經費約590萬元。小鵝瘟是由鵝細小病毒引起的雛鵝急性或亞急性敗血性傳染病，是3-20日齡雛鵝主要致死性傳染病之一，嚴重威脅養鵝業的發展。
小鵝瘟病毒滅活疫苗(TZ10株)使用的毒株是2010年分離的流行毒株，具有更好的免疫原性，可有效刺激機體產生較高水平中和抗體，免疫保護長達5個月；該產品相比弱毒活疫苗具備更高的安全性，可有效避免養殖場造成二次污染；種鵝接種該產品，可使雛鵝獲得母原抗體，實現被動保護的效果，從而極大降低養殖場防疫成本。
在上述新獸藥產品上市銷售前，揚州優邦將按照《獸藥管理條例》、《獸藥產品批准文號管理辦法》的要求，開展產品批准文號申請及報審相關工作。在取得獸藥產品批准文號後，該新獸藥產品方具備上市銷售的條件，預計2020年第二季度可獲得獸藥產品批准文號。
上述新獸藥證書的獲批是公司重視產品自主研發創新能力的結果，新產品將進一步豐富公司水禽類疫苗產品線，鞏固公司在動物疫苗行業的領先地位，對持續提升公司自主研發能力、市場競爭力和可持續發展等方面具有積極的促進作用。
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