HUTCHMED Announces NDA Acceptance in China with Priority Review Status for ORPATHYS® and TAGRISSO® Combination in Lung Cancer Patients with MET amplification After Progression on First-Line EGFR Inhibitor Therapy

Provided By GlobeNewswire

Last update: Jan 2, 2025

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Jan. 02, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (“NDA”) for the combination of ORPATHYS^® (savolitinib) and TAGRISSO^® (osimertinib) for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (“EGFR”) mutation-positive non-small cell lung cancer (“NSCLC”) with MET amplification after disease progression on first-line EGFR inhibitor therapy has been accepted and granted priority review by the China National Medical Products Administration (“NMPA”). ORPATHYS^® is an oral, potent and highly selective MET tyrosine kinase inhibitor (“TKI”). TAGRISSO^® is a third-generation, irreversible EGFR TKI. This acceptance also triggers a milestone payment from AstraZeneca.