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和黃醫藥：自願性公告－和黃醫藥宣佈賽沃替尼 (savolitinib) 治療初治及經治MET外顯子14非小細胞肺癌的新適應症上市申請於中國獲受理

HUTCHMED: VOLUNTARY ANNOUNCEMENT - HUTCHMED Announces Savolitinib sNDA Accepted in China for Treatment-Naive or Previously Treated Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC

香港交易所 ·  Mar 27 20:00
Summary by Moomoo AI
和黃醫藥（HUTCHMED）宣布，其開發的賽沃替尼（savolitinib）用於治療MET外顯子14跳變的非小細胞肺癌新適應症的上市申請已於中國獲國家藥品監督管理局受理。該藥物早前在中國已獲附條件批准，用於治療疾病進展或無法接受化療的患者。IIIb期研究數據顯示，賽沃替尼在初治患者中的中位無進展生存期為13.7個月，中位總生存期尚未達到。若此次申請獲批准，將擴展至更多患者。和黃醫藥與阿斯利康合作，負責賽沃替尼的臨床開發及商業化。和黃醫藥是一家專注於發現、開發和商業化治療癌症和免疫性疾病的生物醫藥公司。
和黃醫藥（HUTCHMED）宣布，其開發的賽沃替尼（savolitinib）用於治療MET外顯子14跳變的非小細胞肺癌新適應症的上市申請已於中國獲國家藥品監督管理局受理。該藥物早前在中國已獲附條件批准，用於治療疾病進展或無法接受化療的患者。IIIb期研究數據顯示，賽沃替尼在初治患者中的中位無進展生存期為13.7個月，中位總生存期尚未達到。若此次申請獲批准，將擴展至更多患者。和黃醫藥與阿斯利康合作，負責賽沃替尼的臨床開發及商業化。和黃醫藥是一家專注於發現、開發和商業化治療癌症和免疫性疾病的生物醫藥公司。
HUTCHMED announced that a listing application for a new indication of its development of savolitinib for the treatment of a new indication of non-small cell lung cancer for the treatment of MET extrapherin-14 mutations has been accepted in China by the National Drug Administration. The drug was previously approved with conditions in China for the treatment of patients with advanced disease or unable to receive chemotherapy. Data from the Phase IIIb study showed that the median progression-free survival period for sevotinic patients was 13.7 months, and the median overall survival was not yet reached. If this application is approved, it will be extended to more patients. He is responsible for the clinical development and commercialization of Savotini in collaboration with Aslicon. WONG PHARMACEUTICALS IS A BIOMEDICAL COMPANY FOCUSED ON THE DISCOVERY, DEVELOPMENT AND COMMERCIALIZATION OF TREATMENTS FOR CANCER AND IMMUNE DISEASES.
HUTCHMED announced that a listing application for a new indication of its development of savolitinib for the treatment of a new indication of non-small cell lung cancer for the treatment of MET extrapherin-14 mutations has been accepted in China by the National Drug Administration. The drug was previously approved with conditions in China for the treatment of patients with advanced disease or unable to receive chemotherapy. Data from the Phase IIIb study showed that the median progression-free survival period for sevotinic patients was 13.7 months, and the median overall survival was not yet reached. If this application is approved, it will be extended to more patients. He is responsible for the clinical development and commercialization of Savotini in collaboration with Aslicon. WONG PHARMACEUTICALS IS A BIOMEDICAL COMPANY FOCUSED ON THE DISCOVERY, DEVELOPMENT AND COMMERCIALIZATION OF TREATMENTS FOR CANCER AND IMMUNE DISEASES.
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