科伦博泰生物核心产品获批新增适应症
3月10日，科伦博泰生物-B（06990）发布公告，公司的核心产品芦康沙妥珠单抗（sac-TMT）近日获得国家药品监督管理局批准，新增适应症用于EGFR突变非小细胞肺癌的治疗。这一批准使得芦康沙妥珠单抗成为全球首个在肺癌适应症获批上市的TROP2抗体药物偶联物（ADC），标志着公司在抗癌药物领域的重要进展。
公告指出，芦康沙妥珠单抗的批准基于一项多中心、随机、对照的关键临床研究，研究结果显示，与多西他赛相比，芦康沙妥珠单抗在客观缓解率、无进展生存期和总生存期方面均有显著改善。这一新适应症的上市预计将显著延长EGFR突变非小细胞肺癌患者的生存期，进一步提升公司的市场竞争力。此前，该药物已获批用于治疗不可切除的局部晚期或转移性三阴性乳腺癌，并且正在申请用于EGFR-TKI治疗失败的EGFR突变NSCLC患者的补充新药申请。
（文章来源：财中社）
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