百利天恆(688506.SH):BL-B01D1(EGFR×HER3雙抗ADC)用於在局部晚期或轉移性尿路上皮癌III期臨牀試驗完成首例受試者入組
格隆匯4月8日丨百利天恆(688506.SH)公佈,自主研發的創新生物藥注射用BL-B01D1(EGFR×HER3雙抗ADC)用於既往經含鉑化療及PD-1/PD-L1抑制劑治療失敗的不可手術切除的局部晚期或轉移性尿路上皮癌患者的III期臨牀試驗已於近日完成首例受試者入組,這是該產品第9項進入III期階段的註冊臨牀研究。
BL-B01D1是全球首創(First-in-class)、新概念(Newconcept)且唯一進入III期臨牀階段的EGFR×HER3雙抗ADC。近日,BL-B01D1用於既往經含鉑化療及PD-1/PD-L1抑制劑治療失敗的不可手術切除的局部晚期或轉移性尿路上皮癌的臨牀研究已進入III期臨牀試驗階段並完成首例受試者入組。截至目前,BL-B01D1正在中國和美國進行30餘項針對多種腫瘤類型的臨牀試驗,除本次新入組的臨牀試驗外,BL-B01D1在非小細胞肺癌、小細胞肺癌、乳腺癌、鼻咽癌、食管鱗癌等8項國內III期註冊臨牀試驗也處於受試者入組的階段。
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