AstraZeneca Licenses Zegfrovy from Dizal in Up to $1.5 Billion Deal to Expand EGFR-Mutated Lung Cancer Portfolio

AstraZeneca has signed an exclusive global licensing agreement with Dizal Pharmaceutical for Zegfrovy (sunvozertinib) in a deal valued at up to $1.5 billion. The agreement includes a $600 million upfront payment, up to $900 million in development, regulatory, and commercial milestone payments, and tiered royalties on global sales. Through the transaction, AstraZeneca will acquire worldwide rights to develop and commercialize the therapy.

Zegfrovy is approved in the United States and China for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations whose disease has progressed following platinum-based chemotherapy. The transaction is expected to close in the second half of 2026, subject to customary regulatory approvals and closing conditions.

EGFR Exon 20 Insertion NSCLC Treatment Remains an Unmet Need

NSCLC accounts for approximately 80% to 85% of all lung cancers. EGFR mutations occur in around 10% to 15% of patients in the US and Europe and 30% to 40% of patients in Asia. Approximately one in four patients with EGFR-mutated NSCLC carries an exon 20 insertion or another atypical EGFR mutation, a subgroup with limited targeted treatment options after standard platinum-based chemotherapy.

Sunvozertinib is an oral, irreversible EGFR inhibitor that selectively targets multiple EGFR mutations while sparing wild-type EGFR. Beyond its approved indication, the therapy has demonstrated antitumor activity in tumors with EGFR sensitizing, T790M, and uncommon mutations, as well as HER2 exon 20 insertions. Clinical studies have shown a manageable safety profile, with most treatment-related adverse events reported as Grade 1 or 2.

Phase III WU-KONG28 Trial Supports First-Line Expansion

The licensing agreement follows positive findings from the global Phase III WU-KONG28 trial (NCT05668988), which evaluated sunvozertinib as a first-line treatment for patients with EGFR exon 20 insertion-positive NSCLC. Results were presented as a Late-Breaking 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 data, supplemental New Drug Applications have been submitted to the US Food and Drug Administration (FDA) and China’s Center for Drug Evaluation (CDE) seeking approval for first-line use. Both agencies have also granted Breakthrough Therapy Designation for sunvozertinib in this setting.

Sunvozertinib is also included in the NCCN Clinical Practice Guidelines in Oncology as a Category 2A recommended subsequent therapy for patients with advanced or metastatic EGFR exon 20 insertion-positive NSCLC following prior systemic treatment.

Leaders Highlight Strategic Importance

Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Haematology Business Unit, said adding Zegfrovy strengthens the company’s leadership in EGFR-mutated lung cancer by expanding treatment options for patients with exon 20 insertion mutations who currently have limited choices.

Dr. Xiaolin Zhang, Chief Executive Officer of Dizal, said AstraZeneca’s global oncology capabilities will help bring the therapy to more patients worldwide while building on innovation discovered by Dizal’s research team in China.

What the Deal Means for AstraZeneca’s Lung Cancer Pipeline

The agreement further strengthens the AstraZeneca lung cancer pipeline, adding a targeted therapy for EGFR exon 20 insertion NSCLC treatment to a portfolio that already includes Tagrisso, Iressa (gefitinib), Imfinzi (durvalumab), Imjudo (tremelimumab), Enhertu (trastuzumab deruxtecan), Datroway (datopotamab deruxtecan), and Orpathys (savolitinib).

If regulators approve sunvozertinib for first-line treatment, the therapy could significantly expand targeted treatment options for patients with EGFR exon 20 insertion-positive NSCLC and reduce reliance on chemotherapy in this difficult-to-treat molecular subtype. The transaction is expected to close in the second half of 2026, after which AstraZeneca will lead global development and commercialization of Zegfrovy.

Reference

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