HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that the National Medical Products Administration (NMPA) in China is currently reviewing a new market approval filing for Orpathys (savolitinib), a MET inhibitor co-developed with AstraZeneca. The company is seeking a new indication for the drug as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that harbor mesenchymal epithelial transition factor (MET) exon 14 skipping alterations. Approval of this new label indication would expand savolitinib’s use to include treatment-naive patients in China.
Orpathys marked a significant milestone for HutchMed when it received its initial approval on July 12, 2023, becoming the first domestically developed MET inhibitor to enter the Chinese market. The initial indication approved was for second-line treatment of patients with NSCLC who have MET exon 14 skipping alterations.- Flcube.com
