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普萊柯(603566.SH):甲氧普烯獲得新獸藥註冊證書
格隆匯 11-10 17:20

格隆匯 11 月 10日丨普萊柯(603566.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,批准公司及全資子公司洛陽惠中獸藥有限公司、河南新正好生物工程有限公司共同申報的甲氧普烯為新獸藥,農業農村部2020119公示了核發《新獸藥註冊證書》(農業農村部公告第350號)事項。

該產品於201459日獲得河南省畜牧局批准的臨牀試驗審批函,經後續臨牀試驗、新獸藥註冊等階段,農業農村部於2020119日公告核發新獸藥註冊證書。截至目前,該項目與對應制劑產品複方非潑羅尼滴劑已累計投入研發費用442萬元。

體外寄生蟲感染犬貓寵物嚴重影響寵物健康,同時寵物攜帶多種人獸共患病原體,直接威脅寵物主人健康及公共衞生安全。目前,全球範圍內對寵物體外寄生蟲感染主要採用抗寄生蟲藥物進行預防和治療

甲氧普烯昆蟲保幼激素類似物,作為昆蟲生長調節劑應用於寵物體外寄生蟲的預防和治療可抑制跳蚤卵發育並導致死亡。甲氧普烯對跳蚤卵具有極強的接觸毒性,作用機制主要包括:通過直接滲透作用穿過卵壁進入新生跳蚤卵或者通過跳蚤成蟲角質上皮的吸入而進入卵內,同時對跳蚤幼蟲和蛹的發育也有很強的抑制作用甲氧普烯獨特的作用機制,使得其可與殺成蟲劑形成高效協同,全面驅殺不同發育階段的體外寄生蟲。目前甲氧普烯聯合其他殺成蟲劑作為活性成分寵物體外驅蟲製劑產品在全球廣泛上市。

基於較好的驅蟲效果、高度安全性和開發寵物用驅蟲高新制劑的需要,公司開發了甲氧普烯原料藥,用作驅蟲類高新制劑產品的原料。該新獸藥為國家二類新獸藥,填補了國內甲氧普烯的空白,以其為原料開發的高新制劑產品具有廣闊的市場前景。

目前,公司從公開渠道未能查詢到市場上流通的同類產品的銷售情況和市場份額。

按照《獸藥管理條例》、《獸藥產品批准文號管理辦法》等相關規定,該產品在上市之前,還應取得農業農村部核發的獸藥產品批准文號預計13個月公司能夠獲得獸藥產品批准文號。

該新獸藥證書的取得公司持續重視科技創新、加大研發投入的結果,該產填補了我國甲氧普烯原料產品的市場空白,公司寵物用化學藥品實現零突破的重要產品對提升公司市場競爭力、推動公司寵物領域戰略佈局的實施具有積極的促進作用。

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