AstraZeneca has completed an exclusive global licensing agreement with Dizal Pharmaceutical for Zegfrovy, an oral lung-cancer medicine, agreeing to pay $600 million upfront and up to $900 million more upon specified development, regulatory and sales milestones.
Dizal will also receive tiered royalties on global sales of Zegfrovy, known generically as sunvozertinib. AstraZeneca said the transaction does not affect its financial guidance for 2026.
The agreement gives AstraZeneca worldwide rights to develop and commercialize Zegfrovy, an irreversible epidermal growth factor receptor, or EGFR, inhibitor. The medicine is approved in the United States and China for adults with locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations whose disease progressed during or after platinum-based chemotherapy.
AstraZeneca plans to launch Zegfrovy in the United States for that second-line indication during the fourth quarter of 2026. The treatment is already available to patients in China.
The company has also submitted Zegfrovy for possible first-line approval in the United States and China. The FDA accepted a supplemental new drug application based on results from the global Phase III WU-KONG28 study in previously untreated patients with EGFR exon 20 insertion mutation-positive non-small cell lung cancer.
China’s Center for Drug Evaluation is reviewing a corresponding application. Both the FDA and the Chinese regulator granted Zegfrovy Breakthrough Therapy Designation for potential first-line use.
AstraZeneca said patients with advanced non-small cell lung cancer carrying EGFR exon 20 insertion mutations have a real-world five-year overall survival rate as low as 8%. Zegfrovy is designed to target a range of EGFR mutations while maintaining selectivity for mutated EGFR over normal EGFR.
The medicine’s U.S. approval is accelerated and was based on overall response rate and duration of response. Continued approval may depend on confirmation of clinical benefit in additional trials.
The drug carries safety warnings, including risks of serious and potentially life-threatening interstitial lung disease or pneumonitis, gastrointestinal adverse reactions, severe skin reactions, eye toxicity and fetal harm. In a safety group of 121 patients, diarrhea occurred in 73%, skin-related adverse reactions in 68%, nausea and vomiting in 43%, and ocular toxicity in 13%.
AstraZeneca said Zegfrovy should be administered with food to reduce gastrointestinal side effects. Patients with suspected interstitial lung disease or pneumonitis should stop treatment while the condition is evaluated, and treatment should be permanently discontinued if the condition is confirmed.
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