HUTCHMED Announces Breakthrough Therapy Designation in China for ORPATHYS® and TAGRISSO® Combination in Certain Lung Cancer Patients After Disease Progression on EGFR Inhibitor Therapy

Core Insights - HUTCHMED's combination therapy of ORPATHYS® and TAGRISSO® has received Breakthrough Therapy Designation from China's NMPA for treating advanced or metastatic EGFR mutation-positive NSCLC with MET amplification after progression on EGFR inhibitors [1][3] Company Overview - HUTCHMED is an innovative biopharmaceutical company focused on developing targeted therapies and immunotherapies for cancer and immunological diseases, employing approximately 5,000 personnel [15] - The company has a collaboration with AstraZeneca for the global development and commercialization of ORPATHYS®, with HUTCHMED leading development in China [12] Drug Development and Trials - The ongoing Phase III SACHI trial is evaluating the efficacy and safety of the ORPATHYS® and TAGRISSO® combination against standard platinum-based chemotherapy in NSCLC patients with MET amplification [2][8] - ORPATHYS® has been conditionally approved in China for patients with MET exon 14 skipping alterations and is included in the National Reimbursement Drug List since March 2023 [9] - The combination has shown promising results in previous studies, leading to the initiation of multiple Phase III trials, including SANOVO and SAFFRON [5][8] Disease Context - Lung cancer is the leading cause of cancer death, with NSCLC accounting for 80-85% of cases; approximately 30-40% of NSCLC patients in Asia have EGFR mutations [4] - MET amplification is a significant mechanism of resistance to EGFR TKIs, with 15-50% of patients experiencing disease progression post-osimertinib presenting with MET aberration [4][10]