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

Core Viewpoint - HUTCHMED's ORPATHYS® (savolitinib) has received full 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, marking a significant advancement in targeted therapy for this patient population [1][4]. Group 1: Approval and Clinical Data - The NMPA's approval was based on data from a confirmatory Phase IIIb clinical trial, which demonstrated the efficacy and safety of ORPATHYS® in patients with MET exon 14 skipping alteration NSCLC [2][4]. - In treatment-naïve patients, the objective response rate (ORR) was 62.1%, disease control rate (DCR) was 92.0%, and median duration of response (DoR) was 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]. Group 2: Safety Profile - The safety profile of ORPATHYS® was found to be tolerable, with no new safety signals observed [3]. - The most common drug-related treatment-emergent adverse events of Grade 3 or above included abnormal hepatic function (16.9%), increased alanine aminotransferase (14.5%), and increased aspartate aminotransferase (12.0%) [3]. Group 3: Market and Development Context - ORPATHYS® is the first selective MET inhibitor approved in China and has been included in the National Reimbursement Drug List since March 2023 [7]. - The drug is also under clinical development for multiple tumor types, including lung, kidney, and gastric cancers, both as a single treatment and in combination with other therapies [7][8]. - HUTCHMED and AstraZeneca have a global licensing and collaboration agreement for the development and commercialization of ORPATHYS®, with HUTCHMED leading the development in China [8][9].