同源康医药-B(02410)：甲磺酸艾多替尼片（TY-9591片）的新药上市申请获国家药品监督管理局受理

智通财经02-06 17:02

智通财经APP讯，同源康医药-B(02410)发布公告，本公司在研1类新药甲磺酸艾多替尼片(TY-9591片)的新药上市申请(NDA)被国家药品监督管理局(NMPA)药品审评中心(CDE)受理。

甲磺酸艾多替尼片(TY-9591片)为奥希替尼的氘代物，生物利用度高，入脑效果好，本次NDA注册申报适应症为具有EGFR外显子19缺失(19DEL)或外显子21(L858R)置换突变，并伴有CNS转移的局部晚期或转移性NSCLC成人患者的一线治疗。I期(TYKM1601101)和II期临床研究(TYKM1601201)数据已初步显示出其对NSCLC脑转移患者非常优异的颅内及全身应答率，临床获益明显，可解决未满足的临床需求，而关键II期临床研究(TYKM1601202)数据更进一步证实其优异疗效，并显示出其优于奥希替尼的颅内应答率和临床获益，甲磺酸艾多替尼片(TY-9591片)对治疗EGFR突变肺癌脑转移患者具有重大的临床价值。

甲磺酸艾多替尼片(TY-9591片)作为奥希替尼的氘代化合物，无论是从化学结构、药理作用、临床有效性和安全性、以及耐药机制分析，甲磺酸艾多替尼片(TY-9591片)都显示出更明显的临床价值和优势，对疾病的预后有明显改善作用。

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