AstraZeneca has entered into an exclusive license agreement with Dizal Pharmaceutical for Zegfrovy (sunvozertinib), a novel oral irreversible Epidermal Growth Factor Receptor (EGFR) inhibitor for patients with lung cancer. AstraZeneca will acquire worldwide rights to develop and commercialise Zegfrovy.

Zegfrovy is approved in the US and China for the treatment of adult patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.

Approximately, 80-85 percent of lung cancer patients globally have NSCLC. About 10-15 percent of NSCLC patients in the US and Europe, and 30-40 percent of patients in Asia, have EGFR-mutated (EGFRm) NSCLC. Roughly 1 in 4 patients with EGFRm NSCLC has a tumor with an exon 20 insertion mutation or other atypical mutation for which targeted treatment options are limited.

Dave Fredrickson, Executive Vice President (EVP), Oncology Haematology Business Unit, AstraZeneca, said, “AstraZeneca is a leader in treating EGFR-mutated lung cancer, and we are eager to add Zegfrovy to our world-class portfolio of innovative medicines for patients whose tumors carry exon 20 insertion mutations. With this agreement, we will bring a differentiated, oral targeted treatment to these patients with limited options across the globe.”

Dizal recently announced positive results from the global WU-KONG28 phase 3 trial of Zegfrovy in first-line NSCLC with exon 20 insertion EGFR mutations. These data were presented as a Late-Breaking Abstract Oral Presentation at the 2026 American Society of Clinical Oncology Annual Meeting and simultaneously published in The New England Journal of Medicine.

Dr. Xiaolin Zhang, Chief Executive Officer (CEO), Dizal Pharmaceutical, said, “As a leading global company with a strong lung cancer franchise, AstraZeneca will help ensure patients around the world can benefit from this innovation discovered by Dizal scientists in China. Zegfrovy is the only oral targeted therapy for EGFR exon 20 insertion Non-Small Cell Lung Cancer approved in the US and China for patients following prior systemic therapy.”

Supported by these results, a Supplemental New Drug Application (sNDA) for approval in the first-line setting has been submitted to the US Food and Drug Administration (FDA) and China’s Center for Drug Evaluation (CDE). The US FDA and China’s CDE have also both granted Breakthrough Therapy Designation (BTD) to Zegfrovy in this setting.

Sunvozertinib (Zegfrovy) is included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for NSCLC as a Category 2A recommended subsequent therapy option for patients with EGFR exon 20 insertion mutation-positive advanced or metastatic NSCLC.