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基石藥業-B(02616.HK):潛在全球同類最佳靶向ROR1抗體偶聯藥物(ADC)獲FDA批准開展臨牀研究
格隆匯 01-03 08:07

格隆匯1月3日丨基石藥業-B(02616.HK)發佈公吿,基石藥業CS5001的臨牀試驗申請(“IND”)已獲得美國食品藥品監督管理局(“FDA”)的試驗可以進行(“SMP”)的通知信函。這是一款潛在全球同類最佳抗體偶聯藥物(“ADC”),靶向受體酪氨酸激酶樣孤兒受體1(receptor tyrosine kinase-like orphan receptor 1, “ROR1”)。CS5001將作為全球研發進展最快的ROR1ADC之一進入臨牀,標誌着基石藥業管線2.0戰略實現又一重要里程碑。

根據披露,ROR1是一種典型的腫瘤胚胎蛋白,在成體組織中低表達或者不表達,而在多種腫瘤中都有高表達,包括各類白血病、非霍奇金淋巴瘤、乳腺癌、肺癌及卵巢癌,因而是一種極具潛力的ADC靶點。CS5001是一種靶向ROR1的ADC,具有許多差異化特徵,包括專有的位元點特異性偶聯、腫瘤選擇性可切割連接子和前藥技術。臨牀前研究數據表明:CS5001在多種表達ROR1腫瘤細胞系展現出了較強的選擇性細胞毒性,並在血液和實體腫瘤異種移植小鼠模型中均顯示出顯著的體內抗腫瘤活性。

基石藥業首席科學官謝毅釗博士表示:“我們非常高興地看到CS5001的IND申請已於2021年獲得FDA的SMP信函。此前CS5001在臨牀前藥理學和藥效學方面的數據令人鼓舞,展示了其在多種血液疾病和惡性實體腫瘤領域的治療潛力。即將啟動的首次人體階段I試驗,旨在評估CS5001在晚期B細胞淋巴瘤和實體瘤中的安全性、耐受性、藥代動力學和初步抗腫瘤活性。我們將全力推進CS5001的這項臨牀試驗,於此同時,我們已遞交了澳大利亞的臨牀試驗申請(CTN),並計劃在近期遞交中國的IND。”

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