On Wednesday, HUTCHMED Announced Savolitinib SNDA Accepted in China For Treatment-Naïve Or Previously Treated Patients With Locally Advanced Or Metastatic MET Exon 14 NSCLC
On Wednesday, HUTCHMED Announced Savolitinib SNDA Accepted in China For Treatment-Naïve Or Previously Treated Patients With Locally Advanced Or Metastatic MET Exon 14 NSCLC
和黄医药周三宣布，沃利替尼SNDA在中国获准用于未接受治疗或之前接受过治疗的局部晚期或转移性MET Exon 14 NSCLC患者
HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) today announces that the supplemental New Drug Application ("sNDA") for savolitinib, in adult patients with locally advanced or metastatic non-small cell lung cancer ("NSCLC") with mesenchymal epithelial transition factor ("MET") exon 14 skipping alteration, has been accepted for review by the China National Medical Products Administration (NMPA). If approved, the new label indication for savolitinib will be expanded to include treatment-naïve patients in China.
和黄医药（中国）有限公司（“和黄医药”）（纳斯达克/AIM: HCM；HKEX: 13）今天宣布，沃利替尼的补充新药申请（“snDa”）适用于局部晚期或转移性非小细胞肺癌（“NSCLC”）间充质上皮转化因子（“MET”）14外显子跳跃变异的成年患者，已被中国国家药品监督管理局（NMPA）接受审查。如果获得批准，沃利替尼的新标签适应症将扩大到包括中国未接受治疗的患者。