AstraZeneca finalizes worldwide licensing agreement for oral EGFR inhibitor Zegfrovy in lung cancer treatment

AstraZeneca announced the successful completion of its previously disclosed exclusive licensing agreement with Dizal Pharmaceutical Co., Ltd. for Zegfrovy, an oral, irreversible inhibitor of the epidermal growth factor receptor developed for patients with lung cancer. Through this agreement, AstraZeneca now holds worldwide rights to develop and commercialize Zegfrovy.

Zegfrovy is currently approved in the United States and China as a second line treatment for adult patients with locally advanced or metastatic non small cell lung cancer carrying EGFR exon 20 insertion mutations. Patients with this mutation type face a real world five year overall survival rate as low as 8 percent, highlighting the significant unmet need for additional treatment options. Zegfrovy is already available to patients in China for second line use, and AstraZeneca plans to launch the treatment in the United States during the fourth quarter of 2026 for this same indication.

Sunvozertinib, marketed as Zegfrovy, is included in the NCCN Clinical Practice Guidelines in Oncology for non small cell lung cancer, where it is recommended as a subsequent therapy for patients with advanced or metastatic disease that is positive for EGFR exon 20 insertion mutations.

A supplemental New Drug Application seeking approval of Zegfrovy for first line use has been accepted by the U.S. Food and Drug Administration, supported by positive results from the global Phase III WU-KONG28 trial evaluating Zegfrovy as a first line treatment for non small cell lung cancer with EGFR exon 20 insertion mutations. These findings were presented as a late breaking abstract oral presentation at the 2026 American Society of Clinical Oncology Annual Meeting and published simultaneously in The New England Journal of Medicine. Zegfrovy has also been submitted for first line approval to China’s Center for Drug Evaluation. Both the U.S. FDA and China’s CDE have granted Breakthrough Therapy Designation to Zegfrovy for this use.

Financial terms

Under the agreement, AstraZeneca will pay Dizal an upfront sum of $600 million, along with additional payments of up to $900 million tied to specific development, regulatory, and sales related milestones. Dizal will also receive tiered royalties based on global sales of Zegfrovy.

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Related Topics and Keywords

AstraZeneca, lung cancer, lung cancer treatment, oral EGFR inhibitor Zegfrovy, ZEGFROVY