HUTCHMED Gets China Approval for Lung Cancer Drug Combo with AstraZeneca

HUTCHMED Received Approval from China

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Announcement

HUTCHMED (China) Limited has received approval from the China National Medical Products Administration (NMPA) for its new drug application merging TAGRISSO® (osimertinib) and ORPATHYS® (savolitinib). The approval will promote the company’s growth and enhance its contribution to the healthcare market.

New Drug Application

The medication is for the treatment of patients suffering from advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-squamous non-small cell lung cancer (NSCLC) along with MET amplification after a specific disease progression on EGFR tyrosine kinase inhibitor (TKI) therapy. ORPATHYS® is one of the oral that is approachable MET TKI. Whereas, TAGRISSO® is an irreversible EGFR TKI. The approval involves US$11 million payment from AstraZeneca, which commercializes both TAGRISSO® and ORPATHYS® in China.

ORPATHYS® was the first considered MET inhibitor to receive approval in China for adult patients with locally metastatic NSCLC, including MET exon 14 skipping alteration. The new approval by the NMPA was confirmed because of its SACHI Phase 3 trial of the TAGRISSO® and ORPATHYS® combination (NCT05015608). It meets the primary ends of progression-free survival (PFS) during its pre-planned interim analysis. The results of the study were announced at the American Society of Clinical Oncology (ASCO) Annual meeting, June 2025. The progress measures the role from the combination designation in 2024 to selection for NDA priority review in 2025.

Views and Statements

Chief of the Shanghai Lung Cancer Center at Shanghai Chest Hospital, School of Medicine, Shanghai Jiaotong University, and principal investigator of the SACHI trial, Professor Shun Lu, said, “The approval of the recent combination drug is a milestone in identifying intricate challenges of lung cancer treatment in China. A region where the EGFR mutation is normal in NSCLC patients. The combinational drug provides chemotherapy-free and continued all-oral medication for patients with MET amplification after successful EGFR inhibitors to sustain a complex resistance mechanism.” Further, “Been a clinician and researcher, I am thrilled for this opportunity, providing targeted therapies to patients and enhancing their treatment outcome through innovative research.”

Chief Executive Officer and Chief Scientific Officer of HUTCHMED, Dr Weiguo Su, said, “The collaboration with AstraZeneca is a compiled vision to transform and elevate oncology care. It has been a crucial ladder to climb to reach a certain achievement. We are motivated to advance this partnership by expanding the continuity chain in research with the treatment settings and introducing the innovative combination to Chinese patients and more regions.”

General Manager of AstraZeneca China Oncology business, Ms Mary Guan, said, “The new treatment option marks a milestone for the company. The partnership with HUTCHMED helps us to expand the reach of TAGRISSO® and ORPATHYS®.”