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先聲藥業(02096.HK):國家藥品監督管理局簽發SIM0272藥物臨牀試驗批准通知書
格隆匯 03-22 20:06

格隆匯3月22日丨先聲藥業(02096.HK)公吿,於2022年3月21日,集團自主研發的抗腫瘤口服蛋白精氨酸甲基轉移酶5(PRMT5)抑制劑SIM0272(產品代號:SCR-6920)已獲得國家藥品監督管理局簽發的藥物臨牀試驗批准通知書,擬用於開展治療晚期惡性腫瘤的臨牀試驗。

SIM0272是集團自主研發針對"合成致死"機制的口服蛋白精氨酸甲基轉移酶5(PRMT5)抑制劑。PRMT5在肺癌、乳腺癌、胃癌、結直腸癌、卵巢癌、白血病和淋巴瘤等多種癌症中過度表達,並與多數的癌症進展和預後差相關,在腫瘤的形成發展中起重要作用。

臨牀前研究顯示SIM0272對PRMT5具有強抑制活性和高選擇性,在體外展現出對多種血液瘤和實體瘤細胞的增殖抑制活性,且單藥能顯著抑制多個小鼠CDX模型中的腫瘤生長,同時具有良好跨種屬藥代動力學性質,安全性較好,治療窗大。

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