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康辰藥業(603590.SH):開展犬用注射用尖吻蝮蛇血凝酶臨牀試驗
格隆匯 02-07 16:31

格隆匯2月7日丨康辰藥業(603590.SH)公佈,近日,公司收到農業農村部簽發的《關於注射用尖吻蝮蛇血凝酶轉寵物用臨牀試驗樣品生產有關意見的函》,經農業農村部研究,原則同意公司用目前注射用尖吻蝮蛇血凝酶製劑生產車間生產的產品,開展申請獸藥註冊的臨牀試驗。截至目前,公司已完成犬用注射用尖吻蝮蛇血凝酶研製的臨牀備案工作,後續公司將根據相關進展情況及時進行披露。

尖吻蝮蛇血凝酶是從尖吻蝮蛇發現的一種類凝血酶,其作用靶點明確,通過水解纖維蛋白原形成纖維蛋白聚合體發揮促凝止血的作用,不含凝血酶原激活物,不激活凝血XⅢ因子,從機制上避免了可能出現血液高凝狀態和正常血管內壁血栓形成的潛在隱患,有望成為療效好、安全性高的犬用止血藥。

尖吻蝮蛇血凝酶是完成了全部氨基酸、基因測序的單組分血凝酶,採用分段直線混合洗脱離子交換層析方法,提高了單組分尖吻蝮蛇血凝酶的收率,並且最終純化產品具有高純度、高比活、高均一性的特點。

截至目前,公司未能從公開渠道獲得其他同類產品的銷售數據。

截至本公吿披露日,公司為該產品投入研究費用303.88萬元(未經審計)。

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