康哲藥業(00867.HK)創新藥德度司他片中國III期橋接試驗完成首例受試者給藥
1月12日,康哲藥業控股有限公司(00867.HK)創新藥德度司他片中國III期橋接試驗完成首例受試者給藥。這是繼該產品在中國通過技術轉移實現試驗製劑本地化生產、獲得1類新藥臨牀批件、順利完成I期藥代動力學研究後的又一重大進展。
該研究為隨機、雙盲、安慰劑對照、多中心的III期橋接試驗,旨在根據血紅蛋白(Hb)水平相對於基線的變化,評估德度司他片治療非透析慢性腎臟病(CKD)貧血的療效。該研究擬入組150例受試者,由中國醫學科學院北京協和醫院牽頭,將在全國約20家中心進行。中華醫學會腎臟病分會副主任委員、中國腎臟病聯盟副主席李雪梅教授擔任組長單位主要研究者,領銜國內腎臟疾病領域權威專家團隊開展此研究。
德度司他片
德度司他片是一種創新型口服低氧誘導因子脯氨酰羥化酶抑制劑(HIF-PHI),通過增加內源性促紅細胞生成素的生成、改善鐵的利用率和減少鐵調素水平以促進紅細胞生成,以治療CKD引起的貧血。在海外,該產品的兩項III期臨牀試驗已取得積極數據,康哲藥業合作伙伴Zydus基於該積極數據已於2021年11月向印度藥品控制總署(DCGI)遞交新藥上市申請。
中國預估有超過1.2億CKD患者,且貧血是CKD常見併發症之一。國內調研顯示,CKD1-5期患者貧血患病率依次為:22.0%、37.0%、45.4%、85.1%和98.2%,而治療達標率(Hb水平達到靶目標值110~120g/L)對於非透析CKD貧血患者來説僅為8.2%,血液透析CKD貧血患者僅為35.2%。德度司他片作為口服創新HIF-PHI,具備良好的治療順應性,有望滿足這一未被滿足的治療需求。
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