Hehuang Pharmaceutical (00013) announced that it has submitted an application for the marketing of a new US drug for the treatment of MET-driven EGFR mutant lung cancer with ORPATHYS® (ORPATHYS®) and TARISSO® (TAGRISSO®)

^{Zhitong Financial App News, Hehuang Pharmaceutical (00013) announced that AstraZeneca has submitted a new drug marketing application to the US Food and Drug Administration (FDA) for the combination therapy of Vorosha® (ORPATHYS®, savolitinib) and Teresa® (TAGRISSO®, osimertinib), for use in the US Food and Drug Administration (FDA)} Treat patients with locally advanced or metastatic non-small cell lung cancer with MET overexpression or amplification during or after treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).

Data from the SAFFRON Global Phase III study supported this new drug marketing application. ^{SAFFRON studies have shown statistically significant and clinically significant improvements in progression-free survival (PFS) and overall survival (OS) in patients whose disease progressed after Teresa ® treatment compared with combination therapy with platinum.} The safety characteristics of this combination therapy are consistent with the known safety of various drugs, and no new safety issues have been identified. The results will be announced during the upcoming Presidential Symposium (Presidential Symposium) of the 2026 European Society of Medical Oncology (ESMO) Annual Meeting.

Third-generation EGFR tyrosine kinase inhibitors (TKIs) have significantly improved treatment outcomes in patients with EGFR mutant non-small cell lung cancer. However, MET overexpression or amplification is one of the most common mechanisms leading to resistance after third-generation EGFR TKI treatment. MET-driven drug resistance is often accompanied by poor prognosis. Currently, in the field of late-line treatment, there is still a huge unmet clinical need for effective and well-tolerated treatment options.

^{Mr. Zheng Zefeng, Acting CEO and Chief Financial Officer of Hutchison Pharmaceuticals, said, “Following approval in China for the combination therapy of Warisa® and Teresa® based on the SACHI Phase III study, the submission of a marketing application is an important step in promoting the benefits of this combination therapy to patients in the US.} The success of the SAFFRON Global Phase III study is the result of a long-term collaboration between Hutchison Pharmaceuticals and AstraZeneca to provide solutions to EGFR mutant lung cancer in MET-driven drug resistance. We will continue to fully support the regulatory review process and are committed to providing this biomarker-based, chemotherapeutic combination therapy to suitable patients.”

According to reports, Warisha ^{® was jointly developed by AstraZeneca and Hutchison Pharmaceuticals and commercialized by AstraZeneca}.