AstraZeneca Licenses Zegfrovy for EGFR Lung Cancer Treatment

AstraZeneca has signed an exclusive licensing agreement with China’s Dizal Pharmaceutical Co., Ltd. to acquire the worldwide rights to develop and commercialize Zegfrovy (sunvozertinib), an oral targeted therapy for a specific type of non-small cell lung cancer (NSCLC).

The deal strengthens AstraZeneca’s growing portfolio of medicines for patients with epidermal growth factor receptor (EGFR)-mutated lung cancer, particularly those with EGFR exon 20 insertion mutations, a group of patients who currently have limited treatment options.

Zegfrovy is already approved in both the United States and China for adults with locally advanced or metastatic non-small cell lung cancer whose tumors carry EGFR exon 20 insertion mutations and whose disease has progressed after treatment with platinum-based chemotherapy.

Under the agreement, AstraZeneca will take over the global development and commercialization of the medicine, expanding its reach to patients worldwide.

Non-small cell lung cancer is the most common form of lung cancer, accounting for about 80% to 85% of all lung cancer cases globally. Among these patients, EGFR mutations are found in around 10% to 15% of cases in the United States and Europe and in 30% to 40% of patients in Asia.

While several targeted treatments are available for common EGFR mutations, patients with EGFR exon 20 insertion mutations have had far fewer treatment choices. According to AstraZeneca, about one in four patients with EGFR-mutated non-small cell lung cancer has either an exon 20 insertion mutation or another uncommon EGFR mutation that is more difficult to treat.

Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Haematology Business Unit, said the company is committed to expanding treatment options for patients with EGFR-mutated lung cancer.

He said AstraZeneca is pleased to add Zegfrovy to its oncology portfolio, noting that the medicine provides a differentiated oral targeted therapy for patients with EGFR exon 20 insertion mutations who currently have limited treatment options around the world.

Dr. Xiaolin Zhang, Chief Executive Officer of Dizal, said the partnership with AstraZeneca will help make the company’s innovation available to more patients globally.

According to Zhang, AstraZeneca’s experience in lung cancer treatment and its global commercial network will help expand access to Zegfrovy, which is currently the only oral targeted therapy approved in both the United States and China for previously treated patients with EGFR exon 20 insertion-positive non-small cell lung cancer.

The agreement comes shortly after Dizal reported positive results from its global Phase 3 WU-KONG28 clinical trial evaluating Zegfrovy as a first-line treatment for patients with EGFR exon 20 insertion-positive non-small cell lung cancer.

The study results were presented as a Late-Breaking Oral Presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and were published at the same time in the New England Journal of Medicine.

Based on the positive Phase 3 data, Dizal has submitted a Supplemental New Drug Application (sNDA) to both the U.S. Food and Drug Administration (FDA) and China’s Center for Drug Evaluation (CDE) seeking approval for the use of Zegfrovy as a first-line treatment.

Both regulatory agencies have also granted Breakthrough Therapy Designation for Zegfrovy in the first-line treatment setting, a status designed to speed the development and review of medicines that may offer significant improvements over existing therapies.

In addition, Zegfrovy has been included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines as a Category 2A recommended subsequent therapy for patients with advanced or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutations.

The licensing agreement further strengthens AstraZeneca’s position in precision oncology, particularly in lung cancer, where the company already markets several EGFR-targeted therapies. By adding Zegfrovy to its portfolio, AstraZeneca aims to expand treatment options for patients with difficult-to-treat EGFR mutations and improve access to targeted therapies in markets around the world.