HK Stock Market Move | HUTCHMED (00013) rises over 3%, announces submission of New Drug Application to FDA for the combination therapy of ORPATHYS and TAGRISSO

HUTCHMED (00013) rose over 3%, up 3.32% as of press time, at HK$23.04, with a turnover of HK$69.4429 million. On the news front, on September 29, HUTCHMED announced that AstraZeneca has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for the combination therapy of ORPATHYS (savolitinib) and TAGRISSO (osimertinib), for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with MET overexpression or amplification whose disease has progressed during or after treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). The New Drug Application is supported by data from the SAFFRON global Phase III study. The SAFFRON study showed that the combination therapy of ORPATHYS and TAGRISSO demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) compared with platinum-based doublet chemotherapy in patients whose disease had progressed after TAGRISSO treatment. The safety profile of the combination therapy was consistent with the known safety profiles of each drug, and no new safety issues were identified. The results will be presented at the Presidential Symposium session of the upcoming 2026 European Society for Medical Oncology (ESMO) Annual Meeting. It is understood that ORPATHYS is jointly developed by AstraZeneca and HUTCHMED, and is commercialized by AstraZeneca.