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通化東寶(600867.SH):URAT1抑制劑(THDBH130片)Ⅱ期臨牀試驗完成首例受試者入組
格隆匯 02-07 16:32

格隆匯2月7日丨通化東寶(600867.SH)公佈,公司全資子公司東寶紫星(杭州)生物醫藥有限公司(簡稱“東寶紫星”)收到國家藥品監督管理局簽發的關於URAT1抑制劑(THDBH130片)的藥物臨牀試驗批准通知書後,已經順利完成I期臨牀試驗,已啟動中國II期臨牀試驗,並於近日成功完成首例受試者入組。

截至公吿日,公司在該項目中研發投入人民幣約4023.52萬元。

URAT1抑制劑(THDBH130片)在獲得國家藥品監督管理局的藥物臨牀試驗批准並完成I期臨牀試驗後,根據國內化學藥品創新藥相關指導原則,申請人已經啟動“一項在成人高尿酸血癥伴或不伴痛風患者中評價THDBH130片的安全性、耐受性,初步臨牀有效性及藥代/藥效動力學特徵的多中心、隨機、雙盲、安慰劑和苯溴馬隆對照IIa期臨牀研究”,主要目的是評估口服THDBH130片安全性、耐受性和初步有效性;次要目的包括評估降尿酸作用、對患者痛風發作的影響及藥代/藥效動力學特徵。試驗目前進展順利,已於近日成功完成首例受試者入組。

目前以URAT1為靶點的排尿酸藥物主要有苯溴馬隆和雷西那德。根據米內網數據,2021年在中國公立醫療機構和城市實體藥店終端,抗痛風製劑銷售額合計約18.78億元,其中苯溴馬隆銷售額約5.50億元。雷西那德未在國內上市。

THDBH130片是一種特異性作用於尿酸排泄通路的高活性、高選擇性、高安全性的尿酸轉運體URAT1抑制劑,I期臨牀試驗結果顯示其具有低系統暴露、高藥理學活性、餐後給藥更優的降尿酸效應特點,具有良好的安全性及耐受性。

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