康緣藥業(600557.SH):收到KYS2301凝膠臨牀試驗批準通知書
格隆匯7月3日丨康緣藥業(600557.SH)公佈,公司近日收到國家藥品監督管理局簽發的1類化學新藥KYS2301凝膠(三種規格)的《藥物臨牀試驗批準通知書》。
KYS2301是公司自主研發的一種新型的趨化因子受體8(CCR8)特異性抑制劑,是具有全新氨基酸序列的多肽分子,爲全球首個針對CCR8靶點的多肽抑制劑,製劑規格爲1%、3%和5%,適應症定位於特應性皮炎。臨牀前研究顯示,KYS2301對CCR8靶點具有高親和力,局部皮膚塗抹KYS2301凝膠對治療特應性皮炎具有良好的藥效作用,毒理學和藥代動力學研究證明KYS2301凝膠安全性高,系統暴露量低,且反覆塗抹耐受性良好。
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