AstraZeneca’s exclusive global licence agreement for novel oral EGFR inhibitor Zegfrovy in lung cancer with Dizal Pharmaceutical

AstraZeneca has recently entered into an exclusive licence agreement with Dizal Pharmaceutical for Zegfrovy which is a novel oral irreversible epidermal growth factor receptor inhibitor developed for patients with lung cancer. Under the terms of the deal, AstraZeneca will take on worldwide rights to develop and commercialise Zegfrovy.

The therapy currently holds approval in both the US and China for the treatment of adults with locally advanced or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutations whose disease has progressed during or following platinum-based chemotherapy.

Non-small cell lung cancer accounts for roughly 80 to 85% of all lung cancer cases globally. Around 10 to 15% of non-small cell lung cancer patients in the US and Europe, and between 30 and 40% in Asia, carry EGFR-mutated disease. Of those, approximately one in four has a tumour with an exon 20 insertion mutation or another atypical mutation for which targeted treatment options remain scarce.

“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 tumours 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,” said Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca.

“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,” said Dr. Xiaolin Zhang, Chief Executive Officer of Dizal.

Positive findings from the global WU-KONG28 Phase III trial of Zegfrovy in first-line non-small cell lung cancer with exon 20 insertion EGFR mutations were recently announced by Dizal. The 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.

Building on these outcomes, a Supplemental New Drug Application for first-line approval has been submitted to both the US Food and Drug Administration and China’s Center for Drug Evaluation, with Breakthrough Therapy Designation granted by both agencies in this setting.

Sunvozertinib is included in the NCCN Clinical Practice Guidelines in Oncology for non-small cell lung cancer as a Category 2A recommended subsequent therapy option for patients with EGFR exon 20 insertion mutation-positive advanced or metastatic non-small cell lung cancer.

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Related Topics and Keywords

AstraZeneca, Dizal Pharmaceutical, lung cancer, oral EGFR inhibitor, ZEGFROVY