Dizal Announces Global Exclusive License Agreement with AstraZeneca for Zegfrovy
Dizal has entered into a global exclusive license agreement with AstraZeneca for Zegfrovy (sunvozertinib), granting AstraZeneca the worldwide rights to develop and commercialize the drug, which is an oral irreversible epidermal growth factor receptor (EGFR) inhibitor for lung cancer patients. Dizal will receive an upfront payment of $600 million, with the potential for milestone payments totaling up to $900 million, along with tiered royalties based on global sales of Zegfrovy.
Zegfrovy is currently approved in the U.S. and China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have EGFR exon 20 insertion mutations and whose disease has progressed following platinum-based chemotherapy. The announcement follows a recent presentation of results from the multicenter Phase III WU-KONG28 study at the 2026 American Society of Clinical Oncology Annual Meeting. A Supplemental New Drug Application for approval in the first-line setting has been submitted to the China Center for Drug Evaluation and the U.S. Food and Drug Administration, both of which have granted Breakthrough Therapy Designation for Zegfrovy in this indication.
Globally, approximately 80-85% of lung cancer patients are diagnosed with NSCLC, and about 10-15% of NSCLC patients in the U.S. and Europe, and 30-40% in Asia, have EGFR mutations as a driving factor in their disease. Among EGFR-mutated NSCLC patients, roughly one in four has tumors with an exon 20 insertion mutation, for which treatment options are limited.
Dr. Xiaolin Zhang, Chief Executive Officer of Dizal, stated that Zegfrovy is the only oral targeted therapy approved in the U.S. and China for EGFR exon 20 insertion non-small cell lung cancer patients after prior systemic therapy. AstraZeneca, recognized as a leading global company in lung cancer treatment, is expected to help ensure that more patients can benefit from this innovation, which was developed by Dizal researchers in China.
Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Hematology Business Unit, emphasized the company’s commitment to treating EGFR-mutated lung cancer and expressed eagerness to include Zegfrovy in their portfolio of innovative treatments for patients with exon 20 insertion mutations. The agreement is anticipated to close in the second half of 2026, pending regulatory approvals and customary closing conditions.