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基石藥業(02616.HK)抗體偶聯藥物獲美國藥監局批准開展臨床研究
阿思達克 01-03 09:40
基石藥業(02616.HK)公布,其CS5001的臨床試驗申請已獲得美國食品藥監局(FDA)的試驗可以進行(SMP)之通知信函。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(酉每)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ROR1 ADC之一進入臨床。 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。
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