HUTCHMED (China) Limited  announces that the New Drug Application (“NDA”) for the combination of ORPATHYS^® (savolitinib) and TAGRISSO^® (osimertinib) has been granted approval by the China National Medical Products Administration (“NMPA”) for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (“EGFR”) mutation-positive non-squamous non-small cell lung cancer (“NSCLC”) with MET amplification after disease progression on EGFR tyrosine kinase inhibitor (“TKI”) therapy. ORPATHYS^® is an oral, potent and highly selective MET TKI. TAGRISSO^® is a third-generation, irreversible EGFR TKI. This approval also triggers a US$11 million milestone payment from AstraZeneca, which markets both ORPATHYS^® and TAGRISSO^® in China.

ORPATHYS^® was the first selective MET inhibitor approved in China, indicated for adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration. This new approval by the NMPA was based on data from the SACHI Phase III trial of the ORPATHYS^® and TAGRISSO^® combination (NCT05015608), having met the pre-defined primary endpoint of progression-free survival (“PFS”) in a pre-planned interim analysis. Primary results were presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting in June 2025. In 2024 the NMPA designated the combination as a Breakthrough Therapy, and in 2025 it granted the NDA Priority Review.

Professor Shun Lu, Chief of the Shanghai Lung Cancer Center at Shanghai Chest Hospital, School of Medicine, Shanghai Jiaotong University, and Principal Investigator of the SACHI trial, said, “The approval of the ORPATHYS^® and TAGRISSO^® combination is a significant milestone in addressing the complex challenges of lung cancer treatment in China, where the EGFR mutation is common amongst NSCLC patients. For patients who develop MET amplification after progressing on EGFR inhibitors, the combination offers a continued all-oral, chemotherapy-free approach to tackle a critical resistance mechanism. As a researcher and clinician, I am excited about the opportunity to offer this targeted therapy to patients, improving their treatment outcomes and quality of life through innovative research.”

“The NMPA approval marks an important step forward in our mission to address MET-driven progression following first-line EGFR-inhibitor therapy in NSCLC patients.” said Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED. “Our collaboration with AstraZeneca, built on a shared vision to transform oncology care, has been crucial in reaching this achievement. We are committed to advancing this partnership, continuing our research into further treatment settings, and bringing this innovative combination to patients in China and beyond.”

Ms Mary Guan, General Manager of AstraZeneca China Oncology Business, said: “This milestone marks the third indication of ORPATHYS^® approved in China, bringing a new treatment option to lung cancer patients who develop MET amplification after progressing on EGFR inhibitor therapy. Through our partnership with HUTCHMED, we are committed to expanding the reach of the ORPATHYS^® and TAGRISSO^® combination to address progression on first-line therapy and help even more patients with this form of lung cancer.”

In the intention to treat (ITT) population of the SACHI trial, the ORPATHYS^® and TAGRISSO^® combination reduced the risk of disease progression by 66% with a median PFS of 8.2 months, compared to 4.5 months for chemotherapy, as assessed by investigators. The independent review committee (IRC) also reported a 60% risk reduction in disease progression, with a median PFS of 7.2 months versus 4.2 months, respectively. The safety profile of the ORPATHYS^® and TAGRISSO^® combination was tolerable and no new safety signals were observed. Treatment-emergent adverse events of Grade 3 or above occurred in 57% of patients in both the ORPATHYS^® plus TAGRISSO^® group and the chemotherapy group, suggesting a favorable safety profile.