Hutchmed announces NMPA approval for Orpathys supplemental new drug application

Hutchmed (HCM) announces that the supplemental new drug application for Orpathys has been granted approval by the China National Medical Products Administration, or NMPA, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer, or NSCLC, with MET exon 14 skipping alteration. The NMPA has also converted the prior conditional approval of Orpathys in the previously treated patient population to full approval. The new label indication for Orpathys will now include both treatment-naive and previously treated patients in China. The approval by the NMPA was based on data from the confirmatory Phase IIIb clinical trial in patients with MET exon 14 skipping alteration NSCLC. Preliminary efficacy and safety data from the first-line cohort were presented during the IASLC World Conference on Lung Cancer in September 2023. Final data from the confirmatory Phase IIIb trial were presented at the European Lung Cancer Congress in March 2024.