Biopharmaceutical company HUTCHMED (China) Limited (Nasdaq:HCM) (AIM:HCM) (HKEX:13) announced on Monday that it has received approval from the China National Medical Products Administration for the combination of ORPATHYS (savolitinib) and TAGRISSO (osimertinib) to treat patients with locally advanced or metastatic EGFR mutation-positive non-squamous non-small cell lung cancer (NSCLC) with MET amplification following progression on EGFR tyrosine kinase inhibitor therapy.

Approval is based on Phase III SACHI trial results, where the combination reduced the risk of disease progression or death by 66% versus chemotherapy, with a median progression-free survival of 8.2 months compared to 4.5 months. An independent review also confirmed a 60% risk reduction. The safety profile was manageable, with no new safety signals.

This marks the first all-oral treatment option for this patient population in China and triggers a USD11m milestone payment from AstraZeneca, which markets both drugs in the country.

SACHI trial data were presented at the American Society of Clinical Oncology Annual Meeting in June 2025, following Priority Review and Breakthrough Therapy Designation in 2024. Additional global studies, including the ongoing SAFFRON Phase III trial, continue to evaluate the combination for broader regulatory submissions.

ORPATHYS was the first selective MET inhibitor approved in China. TAGRISSO, a third-generation EGFR TKI, is widely established in NSCLC treatment globally.

:HCM