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生物股份(600201.SH)子公司獲得獸藥產品批准文號批件
格隆匯 10-22 15:35

格隆匯10月22日丨生物股份(600201.SH)公佈,在前期獲得農業農村部核發相應疫苗新獸藥註冊證書的基礎上,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,准予公司控股子公司遼寧益康生物股份有限公司(“遼寧益康”)生產雞新城疫、傳染性支氣管炎二聯耐熱保護劑活疫苗(LaSota株+H120株)。

通用名稱:雞新城疫、傳染性支氣管炎二聯耐熱保護劑活疫苗(LaSota株+H120株);商品名稱:新支立康;含量規格:500羽份/瓶;1000羽份/瓶;2000羽份/瓶;批文有效期:2019-09-30至2024-09-29。

上述新獸藥產品於2012年獲得臨牀批准,遼寧益康獨立自主研發並完成了臨牀試驗,隨後開展新獸藥證書的註冊申報工作。遼寧益康於2019年8月23日獲得上述產品的新獸藥註冊證書,並積極開展新獸藥產品批准文號的申報工作。截至目前該產品發生的研發費用為334萬元。

公司通過公開渠道未能獲得國內市場雞新城疫、傳染性支氣管炎二聯耐熱保護劑活疫苗(LaSota株+H120株)的具體銷售數據。

遼寧益康取得上述獸藥產品批准文號,是公司持續重視研發創新的結果,將進一步豐富公司獸用疫苗產品結構,對持續提升公司經營業績和市場競爭力具有積極的促進作用。

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