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海思科(002653.SZ):HSK38008口服制劑獲批開展用於治療“前列腺癌”的臨牀試驗
格隆匯 04-05 22:44

格隆匯4月5日丨海思科(002653.SZ)公佈,公司於近日獲得國家藥品監督管理局藥品審評中心下發的《藥物臨牀試驗批准通知書》,藥品名稱為HSK38008。

根據《中華人民共和國藥品管理法》及有關規定,經審查,HSK38008口服制劑符合藥品註冊的有關要求,同意本品開展用於治療“前列腺癌”的臨牀試驗。

HSK38008是公司自主研發的全球首家口服AR-V7降解劑,擬用於前列腺癌的治療。按我國新化學藥品註冊分類規定,其藥品註冊分類為化藥1類。

HSK38008能夠通過蛋白酶體降解途徑,有效達到對AR-V7蛋白的降解作用,並且能夠有效抑制AR突變體(包括AR-V7)介導的轉錄激活作用。細胞增殖結果顯示,HSK38008能夠顯著抑制AR-V7陽性細胞系(如22RV1)中的細胞增殖,並且在與恩雜魯胺聯合使用時表現出對VCAP的抗增殖具有協同作用。體內藥效方面,在AR-V7突變的22RV1去勢小鼠移植瘤模型中,HSK38008劑量依賴性地抑制了腫瘤生長,藥效顯著優於ARV-110和恩雜魯胺。

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