WILMINGTON, Del. — AstraZeneca said it has completed its previously announced exclusive licensing agreement with Dizal Pharmaceutical for ZEGFROVY, an oral EGFR inhibitor used to treat certain patients with lung cancer.
Under the agreement, AstraZeneca has acquired worldwide rights to develop and commercialize ZEGFROVY, also known as sunvozertinib.
The drug is approved in the United States and China as a second-line treatment for adults with locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations.
AstraZeneca said patients with this form of lung cancer have a real-world five-year overall survival rate as low as 8%, highlighting the need for additional treatment options.
ZEGFROVY is already available in China for second-line treatment, and AstraZeneca plans to launch the drug in the United States during the fourth quarter of 2026.
The drug is also included in National Comprehensive Cancer Network clinical guidelines as a subsequent treatment option for patients with advanced or metastatic NSCLC carrying EGFR exon 20 insertion mutations.
A supplemental New Drug Application seeking approval of ZEGFROVY as a first-line treatment has been accepted by the U.S. Food and Drug Administration.
The application is supported by positive results from the global Phase III WU-KONG28 trial evaluating the drug in patients with previously untreated NSCLC carrying EGFR exon 20 insertion mutations. The findings were presented at the 2026 American Society of Clinical Oncology Annual Meeting and published in The New England Journal of Medicine.
ZEGFROVY has also been submitted for first-line approval in China. Both the FDA and China’s Center for Drug Evaluation have granted the drug Breakthrough Therapy Designation in that setting.
Under the licensing agreement, AstraZeneca will pay Dizal $600 million upfront and up to an additional $900 million based on development, regulatory and sales milestones. Dizal will also receive tiered royalties on global sales of ZEGFROVY.
AstraZeneca said the transaction does not affect its 2026 financial guidance.
