Hehuang Pharmaceutical (00013): Applications for regulatory registration of Warisha® and Teresa® for the treatment of MET-driven EGFR mutant lung cancer were accepted in Europe and Japan

Zhitong Finance App News, Hehuang Pharmaceutical (00013) announced that applications for regulatory registration of Vorisha® (savolitinib) and Teresa® (osimertinib) combination therapy in Europe and Japan have been accepted.

In Europe, the European Medicines Agency (EMA) has confirmed and accepted the marketing license application submitted by AstraZeneca to 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).

In Japan, AstraZeneca has submitted a new drug marketing application to the Ministry of Health, Labor, and Welfare of Japan and was accepted to treat patients with unresectable advanced or recurrent non-small cell lung cancer whose disease progresses after receiving EGFR-TKI treatment and is accompanied by excessive MET expression or amplification.

Following the submission to the US Food and Drug Administration (FDA) of a new drug marketing application for the same indications in September 2026, regulatory registration applications in Europe and Japan were accepted, marking further progress in the process of promoting this innovative targeted combination therapy to benefit patients around the world.

The positive results of the SAFFRON Global Phase III study supported this new drug marketing application. The results were announced during the 2026 Presidential Symposium (Presidential Symposium) of the European Society of Medical Oncology (ESMO) Annual Meeting, and simultaneously published in “The New England Journal of Medicine (The New England Journal of Medicine)”.

Compared with platinum-type dual-agent chemotherapy, the combination therapy of Warisa® and Teresa® showed 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 chemotherapy, the combination of Warisza® and Teresa® reduced the risk of disease progression or death by 45% (based on PFS risk ratio [HR] 0.55; 95% confidence interval [CI] 0.42-0.72; p<0.001). The median PFS assessed by the Blind Independent Center for Film Reading (BICR) was 7.6 months for the Warisha® and Teresa® group compared to 5.4 months for the control group. Results from the key secondary endpoint OS showed that compared with chemotherapy, Vorexa® combined with Teresa® reduced the risk of death by 32% (OS HR 0.68; 95% CI 0.50-0.91; p=0.010). Compared to the control group, Warisha® in combination with Teresa® extended the median OS by 4.9 months (17.8 months versus 12.9 months). The safety characteristics of this combination therapy are consistent with the known safety of various drugs, and no new safety issues have been identified.

Third-generation EGFR-TKI has significantly improved treatment outcomes for patients with EGFR mutant non-small cell lung cancer. However, MET overexpression or amplification is one of the most common mechanisms leading to drug 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.

Warisha® was co-developed by AstraZeneca and Hutchison Pharmaceuticals and commercialized by AstraZeneca.