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歌禮制藥-B(01672.HK):FXR激動劑ASC42獲批在中國開展慢性乙型肝炎臨牀試驗
格隆匯 06-07 08:11

格隆匯6月7日丨歌禮制藥-B(01672.HK)公佈,中國國家藥品監督管理局(NMPA)已批准其候選藥物ASC42開展用於治療慢性乙型肝炎(CHB)的臨牀試驗申請。

ASC42是一款由公司完全自主研發的新型高效選擇性非甾類法尼醇X受體(FXR)激動劑。ASC42口服片劑由公司專有製劑技術開發,具有室温下穩定的特點。

體外人原代肝細胞(PHH)研究和小鼠腺相關病毒介導的乙肝病毒(AAV-HBV)感染研究均顯示,ASC42對HBV pgRNA和HBsAg具有顯著的抑制作用,表明ASC42有望實現慢性乙型肝炎功能性治癒。

在抗病毒機制方面,核苷(酸)類似物(直接抗病毒藥物)只能抑制HBV RNA逆轉錄為HBV DNA這一過程,無法抑制HBV cccDNA轉錄為HBV RNA,因此對HBsAg沒有抑制作用。作為FXR激動劑,ASC42對HBV具有獨特的作用機制:ASC42可抑制HBV cccDNA轉錄為HBV RNA,進而抑制HBV RNA翻譯為HBsAg。同時,ASC42可能會降低HBV cccDNA的穩定性。

ASC42是公司第二款用於慢性乙型肝炎功能性治癒的在研新藥。另一款用於慢性乙型肝炎功能性治癒的在研新藥是程序性細胞死亡配體1抗體(PD-L1抗體)ASC22目前正在進行Phase IIb期研究,該款藥物在Phase IIa期研究中表現出良好的安全性,並初步顯示具有降低HBsAg的療效。

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