LONDON (dpa-AFX) - HUTCHMED (China) Limited (HUTCHMED) (HCM) announced 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.
In 2011, AstraZeneca and HUTCHMED entered a global licensing and collaboration agreement to jointly develop and commercialize ORPATHYS. Joint development of ORPATHYS in China is led by HUTCHMED, while AstraZeneca leads development outside of China. HUTCHMED is responsible for the marketing authorization, manufacturing and supply of ORPATHYS in China. AstraZeneca is responsible for the commercialization of ORPATHYS in China and worldwide. Sales of ORPATHYS are recognized by AstraZeneca.
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