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先聲藥業(02096.HK):痛風伴高尿酸血癥藥物SIM1909-13獲批臨牀默示許可
格隆匯 11-19 06:10

格隆匯11月19日丨先聲藥業(02096.HK)發佈公告,2020年11月18日,中國國家藥監局藥品審評中心最新公示,公司1類新藥SIM1909-13獲得臨牀默示許可。根據公開資料,這是一種選擇性抑制尿酸轉運蛋白1(“URAT1”)的小分子創新藥,開發用於治療痛風伴高尿酸血癥。該藥物(前稱URC102)是公司於2019年9月從韓國JW Pharmaceutical(“JW”)公司引進,在與JW合作中,公司負責該藥物在中國的開發和商業化。目前該產品正在韓國開展IIb期臨牀試驗,顯示出良好的臨牀療效和安全性。

URAT1選擇性抑制劑是一種新的痛風治療在研藥物,其通過選擇性地抑制URAT1對尿酸的再吸收及增加尿酸的排泄,有效控制血液尿酸水平。目前中國尚無獲批銷售的URAT1高選擇性抑制劑。

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