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申聯生物(688098.SH):牛口蹄疫O型、A型二價合成肽疫苗成功獲批
格隆匯 03-23 17:58

格隆匯3月23日丨申聯生物(688098.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,批准公司與其他單位聯合申報的牛口蹄疫O型、A型二價合成肽疫苗(多肽0506+0708)為新獸藥,並核發《新獸藥註冊證書》。註冊分類:三類;作用與用途:用於預防牛O型、A型口蹄疫。

該產品系公司與中牧實業股份有限公司等單位聯合研發申報的產品。產品自2014年開始設計研發,針對國內主要牛口蹄疫O型、A型毒株的B細胞抗原表位多肽抗原庫,與牛特異性Th表位結合,可同時誘導細胞免疫和體液免疫,免疫針對性強,對國內不同品種的牛具有高效、廣譜、免疫副反應小、安全性高等特點。公司在該獸藥產品的研發投入2020萬元。

公司表示,該產品的成功獲批,將進一步豐富公司的口蹄疫疫苗產品種類,對公司經營發展具有一定的積極作用。公司自2007年開始生產、銷售豬口蹄疫合成肽疫苗,擁有成熟的口蹄疫合成肽疫苗生產、銷售及管理經驗。該產品不需要新建生產線,可與豬口蹄疫合成肽疫苗共用生產線,能夠提升合成肽疫苗生產線的產能利用率。該產品上市銷售前尚需取得產品批准文號,由於何時取得產品批准文號存在不確定性,預計不會對2021年度經營業績產生較大影響。

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