AstraZeneca has entered into an exclusive licence agreement with Dizal Pharmaceutical for Zegfrovy (sunvozertinib), a novel oral irreversible epidermal growth factor receptor (EGFR) inhibitor for patients with lung cancer.
Zegfrovy is approved in the US and China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, whose disease has progressed while on or after platinum-based chemotherapy.
Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit at AstraZeneca, said: “With this agreement, AstraZeneca will bring a differentiated, oral targeted treatment to these patients with limited options across the globe.”
Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths. Lung cancer is broadly split into small cell lung cancer or NSCLC. Approximately 80-85% of lung cancer patients globally have NSCLC, with approximately 75% of people being diagnosed with advanced NSCLC. Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia, have EGFR-mutated NSCLC.
Xiaolin Zhang, CEO of Dizal said: “Zegfrovy is the only oral targeted therapy for EGFR exon 20 insertion non-small cell lung cancer approved in the US and China for patients following prior systemic therapy.”
Dizal recently announced positive results from the global WU-KONG28 phase 3 trial of Zegfrovy in 1st-line NSCLC with exon 20 insertion EGFR mutations. The data was presented as a Late-Breaking Abstract Oral Presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine.
Supported by these results, a Supplemental New Drug Application for approval in the 1st-line setting has been submitted to the US FDA and China’s Center for Drug Evaluation (CDE). The US FDA and China’s CDE have also both granted Breakthrough Therapy Designation to Zegfrovy in this setting.
AstraZeneca will acquire worldwide rights to develop and commercialise Zegfrovy, making an upfront payment to Dizal of $600m and additional payments of up to $900m upon achievement of specific development, regulatory and sales-related milestones. Additionally, Dizal will receive tiered royalties on the global sales of Zegfrovy. The transaction is expected to close in the second half of 2026.