HUTCHMED Received sNDA for Savolitinib in China

HUTCHMED Announces Acceptance of Savolitinib sNDA in China for Locally Advanced or Metastatic MET Exon 14 NSCLC, Both in Treatment-Naïve and Previously Treated Patients

Overview

HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX: 13) has announced today that the China National Medical Products Administration (NMPA) has accepted the supplemental New Drug Application ("sNDA") for savolitinib, aimed at treating adult patients with locally advanced or metastatic non-small cell lung cancer ("NSCLC") with mesenchymal epithelial transition factor ("MET") exon 14 skipping alteration, for review. If approved, this will expand the label indication for savolitinib to include treatment-naive patients in China.

Previous Approvals

• Savolitinib had previously received conditional approval in China for treating patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are ineligible for chemotherapy. 
• Marketed under the brand name ORPATHYS® by our partner, AstraZeneca, for this patient group, savolitinib stands as the first selective MET inhibitor to gain approval in China. 
• Given that over a third of the world's lung cancer patients reside in China, with approximately 2-3% of NSCLC cases globally featuring tumors with MET exon 14 skipping alterations, this expanded indication holds significant potential.

Result Data at Conference

Preliminary efficacy and safety data from the first-line cohort of the confirmatory Phase IIIb clinical trial (NCT04923945) were shared during the IASLC World Conference on Lung Cancer (WCLC) in September 2023. Subsequently, final data from the same trial were presented at the European Lung Cancer Congress on March 20, 2024.

Study Results

• The findings from this study offer confirmatory evidence supporting savolitinib as a targeted treatment option for both treatment-naïve and previously treated patients with MET exon 14 skipping alteration NSCLC. 
• In treatment-naïve patients, key indicators such as objective response rate ("ORR"), disease control rate ("DCR"), and median duration of response ("DoR") underscore its efficacy. 
• For instance, ORR stood at 62.1%, DCR at 92.0%, and median DoR at 12.5 months. 
• Moreover, the safety profile remained manageable, with no new safety signals observed.

About NSCLC

NSCLC is a prevalent and deadly form of cancer, and identifying actionable mutations like MET exon 14 skipping alterations offers new avenues for targeted therapy. 

• Savolitinib, as a highly selective MET tyrosine kinase inhibitor, has shown promise in addressing this need. 
• With its inclusion in the National Reimbursement Drug List (NRDL) for NSCLC treatment and ongoing clinical development for various tumor types, including lung, kidney, and gastric cancers, savolitinib continues to advance as a crucial asset in the fight against cancer.

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