智通财经APP讯，百利天恒(688506.SH)发布公告，公司自主研发的创新生物药注射用BL-B01D1用于既往经含铂化疗及抗PD-1/PD-L1单抗治疗失败的复发性小细胞肺癌患者已被国家药品监督管理局药品审评中心(简称“药审中心”)纳入突破性治疗品种名单，近日已完成公示。
BL-B01D1是公司自主研发的全球首创也是唯一进入临床阶段的靶向EGFR×HER3的双抗ADC。BL-B01D1正在中国和美国进行超过20项针对多种肿瘤类型的临床试验。包括(i)评估BL-B01D1单药用于癌症后线治疗的7个III期临床试验，包括2个非小细胞肺癌适应症、1个小细胞肺癌适应症、2个乳腺癌适应症、1个食管鳞癌适应症、1个鼻咽癌适应症，(ii)评估其与PD-(L)1疗法联用于一线治疗9种癌症适应症(小细胞肺癌、非小细胞肺癌、鼻咽癌、头颈鳞癌、食管癌、胃癌、结直肠癌、乳腺癌及尿路上皮癌)的8个II期临床试验，(iii)评估其与TKI联用用于肺癌一线治疗的2个II期试验。
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