普萊柯(603566.SH)：“替米沙坦內服溶液”獲得新獸藥註冊證書
格隆匯12月29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，批准公司全資子公司洛陽惠中獸藥有限公司與其他單位共同申報的替米沙坦內服溶液為新獸藥，農業農村部於2020年12月28日公示了核發《新獸藥註冊證書》(農業農村部公吿第374號)事項。
新獸藥名稱：替米沙坦內服溶液；註冊分類：五類；主要成分：替米沙坦；作用與用途：用於治療貓慢性腎病引起的蛋白尿；用法與用量：以替米沙坦計，內服：每1kg體重，貓1mg(相當於本品0.25ml)，一日1次。
該產品於2017年12月26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2020年12月28日公吿核發新獸藥註冊證書。截至目前，該項目累計投入研發費用82.82萬元。
貓慢性腎病是一種不可逆的、進行性發展的慢性代謝疾病，是導致貓死亡的主要慢性病之一。貓患病後生活質量下降、壽命縮短。目前，通過阻斷或降低腎素-血管緊張素-醛固酮系統降低貓慢性腎病引起的蛋白尿水平是臨牀治療的重要手段。
替米沙坦是一種口服非肽類血管緊張素Ⅱ受體拮抗劑，通過選擇性與血管緊張素受體1結合阻滯血管緊張素Ⅱ，發揮抗高血壓和腎臟、心臟保護作用。公司開發的替米沙坦內服溶液具有以下優勢：(1)療效快速，替米沙坦在貓體內藥物動力學特徵良好，口服給藥後血漿藥物濃度在20-30分鐘達到峯值，可快速、穩定地降低尿液中蛋白質水平；(2)安全性高，替米沙坦具有高度靶向性的藥理作用方式，特異性與血管緊張素受體1結合，降低副反應發生率；(3)腎臟負擔低，口服給藥經肝腸循環後在肝臟代謝，而後經膽汁排泄到糞便中，代謝與排泄過程幾乎與腎臟無關，不受腎臟功能影響。
該新獸藥證書的取得是公司持續重視科技創新、加大研發投入的結果，該產品填補了我國替米沙坦內服溶液產品的市場空白，是公司寵物用化學藥品的重要產品，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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