By Fineline Cube 
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its MET tyrosine kinase inhibitor (TKI), Orpathys (savolitinib). The drug is approved for use in combination with AstraZeneca’s EGFR inhibitor Tagrisso (osimertinib) to treat patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has MET amplification following progression on EGFR TKI therapy.
Approval Significance
This approval marks the third indication for Orpathys in China and establishes it as the only all-oral treatment option currently available for this patient population.
Clinical Trial Support
The approval is supported by results from the Phase III SACHI study. An interim analysis demonstrated superior efficacy of the Orpathys-Tagrisso combination over chemotherapy, with a median progression-free survival (PFS) of 8.2 months and a favorable safety profile. No new adverse event signals were identified.
Financial and Development Milestones
The approval has triggered a USD 11 million milestone payment from AstraZeneca to HutchMed. The companies will continue to advance multiple global clinical studies exploring this combination regimen.-Fineline Info & Tech