AstraZeneca (NASDAQ: AZN) has completed an exclusive license agreement with Dizal Pharmaceutical Co., Ltd, giving AstraZeneca worldwide rights to develop and commercialize Zegfrovy (sunvozertinib), an oral irreversible EGFR inhibitor for lung cancer patients.

Zegfrovy is approved in the US and China for second-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR exon 20 insertion mutations. The drug is already available to patients in China, with a US launch planned for the fourth quarter of 2026.

A supplemental New Drug Application for first-line use has been accepted by the US Food and Drug Administration, supported by results from the Phase III WU-KONG28 trial. Those data were presented at the 2026 American Society of Clinical Oncology Annual Meeting and published in The New England Journal of Medicine. A submission for first-line approval has also been made to China's Center for Drug Evaluation. Both the FDA and China's Center for Drug Evaluation have granted Breakthrough Therapy Designation to Zegfrovy in the first-line setting.

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

Under the financial terms of the agreement, AstraZeneca will make an upfront payment of $600 million to Dizal, with up to $900 million in additional payments tied to development, regulatory, and sales milestones. Dizal will also receive tiered royalties on global Zegfrovy sales. AstraZeneca stated the transaction does not affect its financial guidance for 2026.