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君實生物(01877.HK):JS103注射液獲得藥物臨牀試驗批准通知書
格隆匯 05-12 17:45

格隆匯5月12日丨君實生物(01877.HK)發佈公吿,公司收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》,JS103注射液(項目代號“JS103”)的臨牀試驗申請獲得批准。

公吿表示,JS103是公司自主研發的聚乙二醇化尿酸酶衍生物,主要用於高尿酸血癥伴或不伴有痛風的治療,其可催化尿酸氧化成溶解度顯著高於尿酸的尿囊素,從而達到降低血尿酸的作用。高尿酸血癥是由於嘌呤代謝紊亂產生過量尿酸或尿酸排泄受阻,引起血液中尿酸超過臨界值而形成的代謝異常綜合徵。痛風是單鈉尿酸鹽沉積所致的晶體相關性關節病,與高尿酸血癥直接相關。

根據《中國高尿酸血癥與痛風診療指南(2019)》顯示,中國高尿酸血癥總體患病率為13.3%,痛風為1.1%,由高尿酸血癥導致的痛風及相關疾病是中國高發的慢性病之一,因此JS103的開發有望為患者帶來更多的治療選擇。

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