AstraZeneca Closes $600 Million Upfront Zegfrovy License Deal With Dizal

AstraZeneca (AZN ) announced on September 1, 2026 that it has completed its exclusive global license agreement with Dizal Pharmaceutical Co., Ltd for Zegfrovy (sunvozertinib), an oral irreversible epidermal growth factor receptor (EGFR) inhibitor for patients with lung cancer. Under the completed agreement, AstraZeneca has acquired worldwide rights to develop and commercialise Zegfrovy, the company said in a statement.

AstraZeneca will make an upfront payment of $600 million to Dizal, together with additional payments of up to $900 million upon achievement of specific development, regulatory and sales-related milestones. Dizal will also receive tiered royalties on global sales of Zegfrovy. AstraZeneca stated that the transaction does not impact its financial guidance for 2026.

Agreement Terms and Regulatory Status

The completion follows the agreement AstraZeneca announced on July 14, 2026, when the company said the transaction was expected to close in the second half of 2026, subject to customary closing conditions and regulatory clearances. The financial terms disclosed at signing — the $600 million upfront payment, milestone payments of up to $900 million, and tiered royalties — are unchanged in the completion announcement.

Zegfrovy is approved in the US and China for the second-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. In the US, the Food and Drug Administration granted accelerated approval to sunvozertinib on July 2, 2025, for patients whose disease has progressed on or after platinum-based chemotherapy, according to the FDA’s approval notice. The FDA evaluated efficacy in the WU-KONG1B trial, where the confirmed overall response rate was 46% and the median duration of response was 11.1 months in the primary efficacy population of 85 patients. The application received priority review, and sunvozertinib had previously received breakthrough therapy designation.

AstraZeneca said Zegfrovy is already available to patients in China in the second-line setting and that it will launch the medicine in the US during the fourth quarter of 2026 for this indication.

First-Line Expansion and Clinical Program

A supplemental New Drug Application for approval of Zegfrovy in the first-line setting has been accepted by the FDA, supported by positive results from the global WU-KONG28 Phase III trial of Zegfrovy in first-line NSCLC with EGFR exon 20 insertion mutations. AstraZeneca said these data were presented as a Late-Breaking Abstract Oral Presentation at the 2026 American Society of Clinical Oncology Annual Meeting and simultaneously published in The New England Journal of Medicine. Zegfrovy has also been submitted for first-line approval to China’s Center for Drug Evaluation (CDE), and both the FDA and the CDE have granted Breakthrough Therapy Designation in this setting.

Dizal announced the positive WU-KONG28 results on May 29, 2026, stating that sunvozertinib demonstrated superior anti-tumour efficacy compared to platinum-doublet chemotherapy as a first-line treatment for advanced NSCLC with EGFR exon 20 insertion mutations, according to the company’s news listing. Dizal described WU-KONG28 as the first global randomized Phase III study with positive results for an oral, chemo-free, targeted monotherapy regimen in first-line EGFR exon 20 insertion mutation NSCLC.

Sunvozertinib is included in the NCCN Clinical Practice Guidelines in Oncology for NSCLC as a recommended subsequent therapy option for patients with EGFR exon 20 insertion mutation-positive advanced or metastatic disease, AstraZeneca said.

Disease Background and Company Portfolios

According to AstraZeneca’s announcement, patients with NSCLC with EGFR exon 20 insertion mutations experience a real-world five-year overall survival rate as low as 8%, citing published research. Lung cancer is broadly split into small cell lung cancer and NSCLC, the latter accounting for 80-85% of cases, and approximately 75% of people are diagnosed with advanced NSCLC. About 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia, have EGFR-mutated NSCLC. Roughly one in four patients with EGFR-mutated NSCLC has a tumour with an exon 20 insertion mutation or other atypical mutation, AstraZeneca said at the July signing.

At the July 14 signing, Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Haematology Business Unit, said: “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.”

Dr. Xiaolin Zhang, Chief Executive Officer of Dizal, said at the signing: “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.”

AstraZeneca’s lung cancer portfolio includes Tagrisso and Iressa (gefitinib); Imfinzi (durvalumab) and Imjudo (tremelimumab); Zegfrovy (sunvozertinib); Enhertu (trastuzumab deruxtecan) and Datroway (datopotamab deruxtecan) in collaboration with Daiichi Sankyo; and Orpathys (savolitinib) in collaboration with HUTCHMED. Dizal, listed on the Shanghai Stock Exchange under the ticker 688192, is a biopharmaceutical company developing medicines for cancer and immunological diseases.

Zegfrovy is an irreversible EGFR inhibitor targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. AstraZeneca is based in Cambridge, UK, and its medicines are sold in more than 125 countries.