WILMINGTON, DE — AstraZeneca (NYSE: AZN) completed an exclusive licensing agreement for ZEGFROVY, gaining worldwide development and commercialization rights to the lung cancer drug in a deal that includes $600 million upfront and as much as $900 million in additional milestone payments.
The agreement with Dizal Pharmaceutical Co. Ltd. also calls for Dizal to receive tiered royalties on global sales of ZEGFROVY, also known as sunvozertinib. AstraZeneca said the transaction does not affect its 2026 financial guidance.
ZEGFROVY is an oral irreversible epidermal growth factor receptor, or EGFR, inhibitor approved in the U.S. and China as a second-line treatment for adults with locally advanced or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutations.
The drug is already available in China for that indication. AstraZeneca plans to launch it in the U.S. during the fourth quarter of 2026.
The company said patients with non-small cell lung cancer carrying EGFR exon 20 insertion mutations have a real-world five-year overall survival rate as low as 8%, underscoring the need for additional treatment options.
ZEGFROVY is also included in the NCCN Clinical Practice Guidelines in Oncology for non-small cell lung cancer as a subsequent therapy option for patients with advanced or metastatic disease carrying EGFR exon 20 insertion mutations.
AstraZeneca is seeking to move the drug into earlier treatment. The U.S. Food and Drug Administration has accepted a supplemental New Drug Application for first-line use of ZEGFROVY in patients with EGFR exon 20 insertion mutation-positive non-small cell lung cancer.
The application is supported by positive results from the global WU-KONG28 Phase III trial. The findings were presented 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 to China’s Center for Drug Evaluation for approval in the first-line setting. Both the FDA and the Chinese regulator have granted Breakthrough Therapy Designation to the drug for that use.
The completed transaction gives AstraZeneca global control of a drug that is already commercialized in China, approaching a U.S. launch and under regulatory review for expansion into first-line treatment.
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