HUTCHMED (00013) shares rose more than 3%, reaching HK$23.04 as of press time, up 3.32%, with a turnover of HK$69.44 million.

On September 29, HUTCHMED (00013) 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 who have experienced disease progression 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 global Phase III SAFFRON study. The SAFFRON study showed that the combination therapy of Orpathys and Tagrisso, compared with platinum-based doublet chemotherapy, demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) 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 individual drug, and no new safety concerns were identified. The results will be presented at the Presidential Symposium session of the upcoming 2026 European Society for Medical Oncology (ESMO) Congress.

It is reported that Orpathys is jointly developed by AstraZeneca and HUTCHMED, and is commercialized by AstraZeneca.