HUTCHMED Announces NMPA Full Approval for ORPATHYS® (savolitinib) in China for Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC

Core Insights - HUTCHMED's ORPATHYS (savolitinib) has received approval from the China National Medical Products Administration (NMPA) for treating both treatment-naïve and previously treated adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping alteration [1][2][4] Company Developments - The approval was based on data from a confirmatory Phase IIIb clinical trial, which demonstrated significant efficacy and safety in both treatment-naïve and previously treated patients [2][4] - ORPATHYS was previously conditionally approved in June 2021 and has now transitioned to full approval, expanding its indication in China [1][9] - The drug is marketed in partnership with AstraZeneca, representing the first selective MET inhibitor approved in China [5][10] Clinical Data - In treatment-naïve patients, the objective response rate (ORR) was 62.1%, with a disease control rate (DCR) of 92.0% and a median duration of response (DoR) of 12.5 months [3] - For previously treated patients, the ORR was 39.2%, DCR was 92.4%, and median DoR was 11.1 months [3] - The median progression-free survival (PFS) for treatment-naïve patients was 13.7 months, while for previously treated patients, it was 11.0 months [3] Market Context - Lung cancer is the leading cause of cancer death globally, with a significant patient population in China, where over a third of the world's lung cancer patients reside [6] - Approximately 2-3% of NSCLC patients have tumors with MET exon 14 skipping alterations, which are targetable mutations [7] - The approval of ORPATHYS addresses unmet medical needs for NSCLC patients with MET aberrations, enhancing treatment options in this challenging area [4][5]