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通化東寶(600867.SH):三靶點抑制劑產品(THDBH101)中國I期臨牀試驗完成首例受試者入組
格隆匯 02-28 15:36

格隆匯2月28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”)研發的SGLT1/SGLT2/DPP4三靶點抑制劑產品THDBH101膠囊(曾用名:WXSHC071膠囊)在獲得國家藥品監督管理局的藥物臨牀試驗批准後,已經啟動中國I期臨牀試驗,並於近日成功完成首例受試者入組。

THDBH101膠囊在獲得國家藥品監督管理局的藥物臨牀試驗批准後,已經啟動中國I期臨牀試驗。根據國內化學藥品創新藥相關指導原則,公司將開展一項隨機、雙盲、安慰劑對照、單次和多次給藥、劑量遞增及食物影響的I期臨牀試驗,主要目的是考察THDBH101膠囊在中國成人健康受試者中的安全性和耐受性;次要目的包括評估THDBH101膠囊在中國成人健康受試者中的藥代動力學特徵以及代謝和排泄情況,並探索THDBH101膠囊在中國成人健康受試者體內的藥效學指標。該藥物的I期臨牀試驗目前進展順利,已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3671萬元。

THDBH101膠囊是全球首個進入臨牀試驗階段的創新小分子口服SGLT1/SGLT2/DPP4三靶點抑制劑。

該藥物在SGLT2經典、成熟作用機制的基礎上,通過SGLT1和DPP4的協同作用,藉助SGLT1在腸道調節葡萄糖吸收的作用進一步加強降糖效應,同時引入對體內DPP4的抑制作用發揮更穩定、持久的降糖效應,起到多種作用機制發揮疊加效果的作用。在2型糖尿病患者的血糖控制中預期可獲得更為有利的有效性和安全性結果,同時有望建立除降糖以外的臨牀獲益基礎,發揮心血管、腎臟、肝臟等方面的保護作用。該藥物目前在全球尚無同類品種上市,亦無同類產品銷售數據。

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