share_log

和黃醫藥：自願性公告－和黃醫藥宣佈沃瑞沙 (ORPATHYS) 和泰瑞沙 (TAGRISSO) 的聯合療法在中國獲納入突破性治療品種用於治療EGFR抑制劑治療後疾病進展的特定的肺癌患者

HUTCHMED: VOLUNTARY ANNOUNCEMENT - HUTCHMED Announces Breakthrough Therapy Designation in China for ORPATHYS and TAGRISSO Combination in Certain Lung Cancer Patients After Disease Progression on EGFR Inhibitor Therapy

HKEX ·  Dec 12 12:09

Summary by Moomoo AI

和黃醫藥宣佈，中國國家藥監局藥品審評中心將沃瑞沙®（賽沃替尼）和泰瑞沙®（奧希替尼）的聯合療法納入突破性治療藥物品種。該療法用於治療伴有MET擴增的EGFR突變陽性局部晚期或轉移性非小細胞肺癌患者，這些患者在接受EGFR抑制劑治療後出現疾病進展。此認定可能有助於加快該創新療法的開發和審評速度，以更快地滿足患者需求。目前，該聯合療法正在SACHI中國III期研究中進行評估，比較其與標準鉑類雙藥化療的療效和安全性。研究的主要終點是無進展生存期（PFS）。MET異常是EGFR TKI產生耐藥性的主要機制，在奧希替尼治療後疾病進展的患者中，約有15-50%出現MET異常。沃瑞沙®已在中國獲附條件批准，用於治療MET外顯子14跳躍突變的非小細胞肺癌患者，並已納入國家醫保藥品目錄。和黃醫藥與阿斯利康合作開發沃瑞沙®，在中國負責上市許可、生產和供應，而阿斯利康負責全球商業化。
和黃醫藥宣佈，中國國家藥監局藥品審評中心將沃瑞沙®（賽沃替尼）和泰瑞沙®（奧希替尼）的聯合療法納入突破性治療藥物品種。該療法用於治療伴有MET擴增的EGFR突變陽性局部晚期或轉移性非小細胞肺癌患者，這些患者在接受EGFR抑制劑治療後出現疾病進展。此認定可能有助於加快該創新療法的開發和審評速度，以更快地滿足患者需求。目前，該聯合療法正在SACHI中國III期研究中進行評估，比較其與標準鉑類雙藥化療的療效和安全性。研究的主要終點是無進展生存期（PFS）。MET異常是EGFR TKI產生耐藥性的主要機制，在奧希替尼治療後疾病進展的患者中，約有15-50%出現MET異常。沃瑞沙®已在中國獲附條件批准，用於治療MET外顯子14跳躍突變的非小細胞肺癌患者，並已納入國家醫保藥品目錄。和黃醫藥與阿斯利康合作開發沃瑞沙®，在中國負責上市許可、生產和供應，而阿斯利康負責全球商業化。
Hutchmed (China) announced that the Center for Drug Evaluation of China's National Medical Products Administration has included the combination therapy of Vorasidenib® (Savolitinib) and Tarsiva® (Osimertinib) in the category of breakthrough therapies. This therapy is used to treat patients with locally advanced or metastatic non-small cell lung cancer positive for EGFR mutations with MET amplification, who have experienced disease progression after treatment with EGFR inhibitors. This designation may help accelerate the development and review process of this innovative therapy to meet patient needs more quickly.Currently, this combination therapy is being evaluated in the SACHI China Phase III study, comparing its efficacy and safety with standard platinum-based doublet chemotherapy. The primary endpoint of the study is progression...Show More
Hutchmed (China) announced that the Center for Drug Evaluation of China's National Medical Products Administration has included the combination therapy of Vorasidenib® (Savolitinib) and Tarsiva® (Osimertinib) in the category of breakthrough therapies. This therapy is used to treat patients with locally advanced or metastatic non-small cell lung cancer positive for EGFR mutations with MET amplification, who have experienced disease progression after treatment with EGFR inhibitors. This designation may help accelerate the development and review process of this innovative therapy to meet patient needs more quickly.Currently, this combination therapy is being evaluated in the SACHI China Phase III study, comparing its efficacy and safety with standard platinum-based doublet chemotherapy. The primary endpoint of the study is progression-free survival (PFS). MET abnormalities are a major mechanism of resistance to EGFR TKIs, and approximately 15-50% of patients experiencing disease progression after treatment with Osimertinib show MET abnormalities.Vorasidenib® has received conditional approval in China for the treatment of non-small cell lung cancer patients with MET exon 14 skipping mutations and has been included in the national medical insurance drug list. Hutchmed (China) is collaborating with AstraZeneca to develop Vorasidenib®, responsible for marketing authorization, production, and supply in China, while AstraZeneca is responsible for global commercialization.

This announcement is a separate document:

Doc 1     View Translation

Disclaimer: This content is for informational and educational purposes only and does not constitute a recommendation or endorsement of any specific investment or investment strategy. Read more
    Heat List
    US
    SymbolLatest Price% Chg

    No Data

    Hot News
    Updated