中國生物製藥(01177.HK)"TQB2101 (ROR1 ADC)"臨牀試驗申請獲NMPA批准
格隆匯4月3日丨中國生物製藥(01177.HK)公吿,集團自主研發的"TQB2101(ROR1 ADC)"已獲得中國國家藥品監督管理局(NMPA)的臨牀試驗默示許可,擬用於治療晚期惡性腫瘤。
受體酪氨酸激酶樣孤兒受體1(ROR1)是Ⅰ型受體酪氨酸激酶家族中的一類跨膜蛋白,在成人正常組織中表達水平低,但在血液系統惡性腫瘤、肺癌、胰腺癌、乳腺癌、結腸癌、卵巢癌等多種惡性腫瘤中都有較高的表達。研究顯示,腫瘤細胞的惡性程度及侵襲行為與ROR1的表達水平密切相關。
臨牀前研究數據顯示,TQB2101在多種ROR1陽性腫瘤模型中展現出抗腫瘤活性,且具有良好的安全性特徵。此次獲批的I期臨牀試驗將重點評估其在人體內的安全性、耐受性、藥代動力學特性及初步療效。
包含TQB2101在內,集團共有四款抗體偶聯藥物(ADC)處於臨牀階段,其中,TQB2102(HER2雙抗ADC)位於臨牀III期,TQB2103(Claudin18.2 ADC)位於臨牀I期、TQB6411(EGFR/c-Met雙抗ADC)位於臨牀申請階段。集團將加速推進臨牀開發進程,並依託自主搭建的ADC技術平台,全力開發更多創新藥,以健康科技,温暖更多生命。
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