AstraZeneca enters exclusive global license agreement for novel oral EGFR inhibitor Zegfrovy for lung cancer with Dizal Pharmaceutical

AstraZeneca has secured an exclusive global license agreement with Dizal Pharmaceutical to develop and commercialize Zegfrovy (sunvozertinib), a novel oral EGFR inhibitor targeting specific lung cancer mutations. The therapy is currently approved in the United States and China for patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations who have progressed after chemotherapy. This deal strengthens AstraZeneca's oncology portfolio by addressing a significant unmet need in the targeted treatment landscape for genetically driven lung cancers.

Under the terms of the agreement, AstraZeneca will pay Dizal Pharmaceutical an upfront sum of $600 million, with potential additional payments reaching $900 million based on the achievement of specific development, regulatory, and sales-related milestones. Dizal is also eligible to receive tiered royalties on future global sales of Zegfrovy. The transaction, which is expected to close in the second half of 2026 pending regulatory clearances, will grant AstraZeneca worldwide rights to the drug. AstraZeneca confirmed that the deal will not impact its financial guidance for the 2026 fiscal year.

Zegfrovy is a differentiated, irreversible EGFR inhibitor designed to target a wide spectrum of mutations, specifically addressing EGFR exon 20 insertion mutations which occur in approximately one in four patients with EGFR-mutated NSCLC. While already approved for second-line treatment, Dizal recently reported positive results from the global WU-KONG28 Phase III trial evaluating the drug as a first-line therapy. These findings, published in The New England Journal of Medicine, have supported Supplemental New Drug Applications currently under review by the U.S. FDA and China’s Center for Drug Evaluation, both of which have granted the therapy Breakthrough Therapy Designation for the first-line setting.

The acquisition aligns with AstraZeneca’s established leadership in lung cancer, complementing a portfolio that includes Tagrisso, Imfinzi, and Enhertu. Lung cancer remains the leading cause of cancer-related deaths globally, with NSCLC accounting for up to 85% of cases. Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, emphasized that Zegfrovy provides a critical oral targeted option for patients who previously had limited treatment choices. Beyond exon 20 insertions, the drug has shown anti-tumour activity in patients with other uncommon mutations and HER2 exon 20 insertions, maintaining a manageable safety profile where most adverse events were reported as Grade 1 or 2.