AstraZeneca has completed a license agreement with Dizal Pharmaceutical for Zegfrovy (sunvozertinib), an oral irreversible epidermal growth factor receptor (EGFR) inhibitor for patients with lung cancer.
Under the agreement, AstraZeneca has acquired worldwide rights to develop and commercialise Zegfrovy.
AstraZeneca will make an upfront payment of $600 million to Dizal, along with additional payments of up to $900 million upon the achievement of specified development, regulatory and sales-related milestones. Dizal will also receive tiered royalties on global sales of Zegfrovy.
Zegfrovy is approved in the US and China for the 2nd-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.
Patients with NSCLC harbouring EGFR exon 20 insertion mutations experience a real-world five-year overall survival rate as low as 8%,underscoring the unmet need for new treatment options.
Zegfrovy is already available to patients in China in the second-line setting, while AstraZeneca plans to launch the drug in the US during the fourth quarter of 2026 for this indication.
A supplemental New Drug Application for approval of Zegfrovy in the 1st-line setting has been accepted by the US Food and Drug Administration (FDA), supported by positive results from the global WU-KONG28 Phase III trial evaluating Zegfrovy as a first-line treatment for NSCLC with EGFR exon 20 insertion mutations.
Zegfrovy has also been submitted for approval in the first-line setting to China’s Center for Drug Evaluation (CDE).
The US FDA and China’s CDE have both granted Breakthrough Therapy Designation to Zegfrovy for this setting.
