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
和黃醫藥週三宣佈，沃利替尼SNDA在中國獲准用於未接受治療或之前接受過治療的局部晚期或轉移性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.
和黃醫藥（中國）有限公司（“和黃醫藥”）（納斯達克/AIM: HCM；HKEX: 13）今天宣佈，沃利替尼的補充新藥申請（“snDa”）適用於局部晚期或轉移性非小細胞肺癌（“NSCLC”）間充質上皮轉化因子（“MET”）14外顯子跳躍變異的成年患者，已被中國國家藥品監督管理局（NMPA）接受審查。如果獲得批准，沃利替尼的新標籤適應症將擴大到包括中國未接受治療的患者。