申聯生物(688098.SH)：品豬口蹄疫O型合成肽疫苗等產品獲得獸藥產品批准文號批件
格隆匯9月7日丨申聯生物(688098.SH)公佈，公司產品豬口蹄疫O型合成肽疫苗(多肽2600+2700+2800)及豬口蹄疫O型、A型二價合成肽疫苗(多肽2700+2800+MM13)於近日獲得中華人民共和國農業農村部核發的獸藥產品批准文號批件。
合成肽疫苗屬於新型疫苗，具有安全、穩定、精準的特點，是研製預防和控制傳染性疾病和惡性腫瘤的新型疫苗的主要方向之一，應用前景廣闊。多年來，公司專注於口蹄疫合成肽疫苗的研發及生產，利用口蹄疫合成肽疫苗技術平台優勢，實現了產品及技術的升級換代，從單組份升級為雙組份、三組份，從O型單價發展為O型、A型二價，不斷滿足用户的需求。其中，豬口蹄疫O型合成肽疫苗(多肽2600+2700+2800)於2014年獲得新獸藥註冊證書，該產品能同時預防三種O型口蹄疫流行毒株；豬口蹄疫O型、A型二價合成肽疫苗(多肽2700+2800+MM13)於2018年獲得新獸藥註冊證書，是國內首個豬口蹄疫O型、A型二價合成肽疫苗產品，能同時預防O型、A型兩種血清型的口蹄疫疫病。
豬口蹄疫O型合成肽疫苗(多肽2600+2700+2800)、豬口蹄疫O型、A型二價合成肽疫苗(多肽2700+2800+MM13)均為我國豬口蹄疫合成肽疫苗市場中的主要產品。公司分別自2016年、2019年開始生產銷售，目前僅公司銷售上述兩種產品。公司未能從公開渠道獲得其他公司類似產品的具體銷售數量及金額。
此次取得上述產品批准文號批件，標誌着上述產品具備上市銷售條件。產品銷售之前，除履行產品批簽發程序外，無需履行其他審批程序。公司作為國內口蹄疫合成肽疫苗領域的領軍者，是國內最早研究合成肽疫苗的企業之一，在全球範圍內率先實現口蹄疫合成肽疫苗產業化，在國內口蹄疫疫苗用户中有良好的信譽和廣泛的市場。目前豬口蹄疫O型合成肽疫苗(多肽2600+2700+2800)、豬口蹄疫O型、A型二價合成肽疫苗(多肽2700+2800+MM13)已獲得獸藥產品批准文號，產品上市後將有利於鞏固公司的在口蹄疫合成肽疫苗領域的行業地位和競爭優勢，有利於公司的穩健運營及長遠發展。
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