AstraZeneca has entered into an exclusive global licensing agreement with Dizal Pharmaceutical for Zegfrovy, an oral targeted therapy approved in the U.S. and China for certain patients with non-small cell lung cancer.
Under the agreement, AstraZeneca will pay Dizal $600 million upfront and up to an additional $900 million upon the achievement of development, regulatory, and sales milestones. Dizal will also be eligible to receive tiered royalties on worldwide sales of Zegfrovy.
The potential milestone payments bring the total value of the transaction to as much as $1.5 billion, excluding royalties.
AstraZeneca will acquire worldwide rights to develop and commercialize Zegfrovy, also known as sunvozertinib. The transaction is expected to close during the second half of 2026, subject to regulatory clearances and other customary closing conditions.
The agreement expands AstraZeneca’s portfolio of medicines targeting mutations in the epidermal growth factor receptor, or EGFR, which can drive the growth of certain lung cancers.
Zegfrovy is a novel, irreversible EGFR inhibitor designed to target a broad spectrum of EGFR mutations while maintaining selectivity over wild-type EGFR.
The therapy is approved in the U.S. and China for adult patients with locally advanced or metastatic non-small cell lung cancer whose tumors carry EGFR exon 20 insertion mutations and whose disease has progressed during or after platinum-based chemotherapy.
Zegfrovy is currently the only oral targeted therapy approved in both countries for previously treated patients with this form of lung cancer, according to Dizal.
Approximately 80% to 85% of lung cancer cases worldwide are classified as non-small cell lung cancer. About 10% to 15% of patients with NSCLC in the U.S. and Europe, and 30% to 40% of patients in Asia, have tumors with EGFR mutations.
Roughly one-quarter of patients with EGFR-mutated NSCLC have exon 20 insertion mutations or other less common mutations for which targeted treatment options remain limited.
AstraZeneca said the licensing agreement will complement its existing leadership in EGFR-mutated lung cancer and enable the company to make Zegfrovy available to additional patients worldwide.
The company already markets Tagrisso, one of the most widely used targeted medicines for EGFR-mutated NSCLC. Adding Zegfrovy gives AstraZeneca another oral medicine addressing a different and historically difficult-to-treat group of EGFR mutations.
EGFR exon 20 insertion mutations can alter the structure of the receptor in ways that reduce the effectiveness of many earlier-generation EGFR inhibitors. This has created a need for medicines specifically engineered to inhibit these mutations while maintaining a manageable safety profile.
Dizal recently reported positive results from the global Phase III WU-KONG28 trial evaluating Zegfrovy as a first-line treatment for patients with locally advanced or metastatic NSCLC carrying EGFR exon 20 insertion mutations.
The clinical results were presented as a late-breaking oral presentation at the 2026 American Society of Clinical Oncology Annual Meeting and published simultaneously in The New England Journal of Medicine.
Based on the Phase III results, applications seeking approval for Zegfrovy in the first-line setting have been submitted to the U.S. Food and Drug Administration and China’s Center for Drug Evaluation.
Both regulators have granted Breakthrough Therapy Designation to Zegfrovy for the first-line treatment of patients with EGFR exon 20 insertion mutation-positive NSCLC.
The designation is intended to facilitate the development and review of medicines that may offer a substantial improvement over available treatments for serious or life-threatening diseases.
If approved for first-line use, Zegfrovy could be prescribed before platinum-based chemotherapy rather than only after a patient’s disease has progressed following prior systemic treatment.
Zegfrovy is also included in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for NSCLC as a Category 2A-recommended subsequent treatment option for patients with advanced or metastatic disease harboring EGFR exon 20 insertion mutations.
Beyond exon 20 insertion mutations, Zegfrovy has demonstrated encouraging anti-tumor activity in patients with NSCLC carrying EGFR-sensitizing mutations, the T790M resistance mutation, other uncommon EGFR mutations, and HER2 exon 20 insertion mutations.
Dizal said the therapy has demonstrated a generally well-tolerated and manageable safety profile in clinical testing. Most treatment-related adverse events were classified as Grade 1 or Grade 2 and were considered clinically manageable.
AstraZeneca plans to use its global oncology development, regulatory, manufacturing, and commercial capabilities to expand access to the medicine.
The agreement represents a significant opportunity for Dizal to extend the global reach of a therapy discovered by its scientists in China.
Dizal will retain the economic benefits from the upfront payment, potential milestone payments, and tiered sales royalties, while AstraZeneca assumes responsibility for worldwide development and commercialization.
The transaction also reflects the growing role of Chinese biotechnology companies in discovering medicines that are later licensed to global pharmaceutical companies for international development.
Zegfrovy will join AstraZeneca’s broad lung cancer portfolio, which includes medicines targeting different disease stages, biomarkers, and mechanisms.
Along with Tagrisso and Iressa, AstraZeneca’s lung cancer portfolio includes the immunotherapies Imfinzi and Imjudo.
The company also markets Enhertu and Datroway in collaboration with Daiichi Sankyo and develops Orpathys in collaboration with HUTCHMED.
AstraZeneca is advancing additional investigational medicines and combination therapies intended to address resistance mechanisms and improve outcomes in early-stage and advanced lung cancer.
The company’s broader strategy is to identify the specific molecular features driving each patient’s cancer and match patients with the treatments most likely to benefit them.
AstraZeneca is also a founding member of the Lung Ambition Alliance, a global coalition focused on accelerating advances in lung cancer detection, diagnosis, and treatment.
The Zegfrovy transaction is not expected to affect AstraZeneca’s financial guidance for 2026.
KEY QUOTES:
“AstraZeneca is a leader in treating EGFR-mutated lung cancer, and we are eager to add Zegfrovy to our world-class portfolio of innovative medicines for patients whose tumours carry exon 20 insertion mutations. With this agreement, we will bring a differentiated, oral targeted treatment to these patients with limited options across the globe.”
Dave Fredrickson, Executive Vice President of the Oncology Haematology Business Unit at AstraZeneca
“As a leading global company with a strong lung cancer franchise, AstraZeneca will help ensure patients around the world can benefit from this innovation discovered by Dizal scientists in China. 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.”
Dr. Xiaolin Zhang, Chief Executive Officer of Dizal Pharmaceutical
