港股異動 | 基石藥業-B高開3.5% 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1月4日丨基石藥業-B(2616.HK)高開3.61%,報8.62港元,總市值102億港元。基石藥業-B1月3日發佈公吿,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。另外,1月4日,公司發佈公吿,洛拉替尼(lorlatinib,曾用名:勞拉替尼)針對c-ros oncogene1(“ROS1”)陽性晚期非小細胞肺癌(“NSCLC”)的臨牀試驗申請(“IND”)已獲中國國家藥品監督管理局(“NMPA”)批准。這是全球首個洛拉替尼用於治療ROS1陽性NSCLC的關鍵性研究。

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