AstraZeneca (LSE/STO/NYSE: AZN) has completed an exclusive global license agreement with Dizal Pharmaceutical Co., Ltd for ZEGFROVY (sunvozertinib), an oral irreversible EGFR inhibitor for non-small cell lung cancer (NSCLC), according to a company statement.

Under the terms of the agreement, AstraZeneca will pay Dizal $600 million upfront, plus up to $900 million in development, regulatory, and sales-related milestone payments. Dizal will also receive tiered royalties on global ZEGFROVY sales. AstraZeneca said the transaction does not affect its financial guidance for 2026.

ZEGFROVY is currently approved in the US and China for second-line treatment of adults with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations. The drug is already available to patients in China, and AstraZeneca plans a US launch in the fourth quarter of 2026.

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

Patients with NSCLC with EGFR exon 20 insertion mutations have a reported real-world five-year overall survival rate as low as 8%. The drug's current US approval is based on overall response rate and duration of response under accelerated approval, with continued approval contingent on confirmatory trial results.