康緣藥業(600557.SH)收到藥物臨牀試驗批准通知書
格隆匯8月25日丨康緣藥業(600557.SH)公佈,近日,公司申報的WXSH0493片收到國家藥品監督管理局簽發的《藥物臨牀試驗批准通知書》,同意該藥品進行臨牀試驗。藥品名稱:WXSH0493片;適應症:痛風
痛風和高尿酸血癥已經逐漸成為一類嚴重的代謝類疾病,發作率呈逐年上升態勢,並與一系列併發症密切相關,目前的一線用藥存在療效差、副作用大等缺陷,同時在患者中都具有一定的使用限制。lesinurad作為上市的第一個尿酸轉運體(URAT1)抑制劑藥物,在多個Ⅲ期臨牀實驗中只展現了中等藥效,並展現了較多的臨牀毒副作用。
WXSH0493是根據lesinurad在臨牀應用中暴露出的問題而針對性設計的,重點解決了如何提高藥效、如何降低OAT4抑制、如何避免高活性代謝中間體等幾個關鍵問題,並取得了積極的成果。WXSH0493將在痛風和高尿酸血癥患者的臨牀治療中提供一個新的用藥選擇,成藥後有望解決這些患者尚未滿足的臨牀需求,具有顯著的臨牀價值。截至本公告披露日,公司對WXSH0493片累計研發投入2258.58萬元。
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