Sunvozertinib

Nearly a decade after spinning out its Chinese research hub to form Dizal Pharmaceutical, AstraZeneca is paying up to $1.5 billion to buy a piece of the pipeline, securing exclusive global rights for the biotech’s oral EGFR lung cancer drug Zegfrovy (sunvozertinib). The total deal value is split between $600 million in upfront payment, up to $400 million in development milestones and another $500 million tied to certain sales milestones, according to a disclosure (Chinese, PDF) to the Shanghai Stock Exchange. Dizal is also entitled to tiered, up to low-double-digit royalties based on Zegfrovy’s global sales. The deal comes about a month after Dizal detailed positive phase 3 data for Zegfrovy in first-line non-small cell lung cancer with EGFR exon 20 insertion mutations at the 2026 American Society of Clinical Oncology annual meeting. In the global Wu-Kong28 trial, Zegfrovy significantly reduced the risk of disease progression or death by 35% compared with platinum-based chemotherapy. Dizal has filed for a label expansion with the U.S. FDA and China’s Center for Drug Evaluation. Zegfrovy got its initial, accelerated approval a year ago for previously treated NSCLC with EGFR exon 20 insertion mutations. When presenting the Wu-Kong28 results, John Heymach, M.D., chair of thoracic/head and neck medical oncology at MD Anderson Cancer Center, said Zegfrovy offers “the advantage of a single oral agent administration” compared with Johnson & Johnson’s three-drug combination of injected Rybrevant and carboplatin and pemetrexed chemotherapy. Dizal had been hunting for a Zegfrovy partner ahead of the Wu-Kong28 readout, but potential suitors chose to wait for the data in light of Takeda’s high-profile failure with Exkivity in the same lung cancer setting, Dizal CEO Xiaolin Zhang, Ph.D., told Fierce Pharma on the sidelines of ASCO 2026. In a potential partner, Dizal was looking for a large company with global reach and experience in marketing targeted therapy, Zhang said at the time. AZ has both. The company’s Tagrisso for NSCLC with EGFR exon 19 and 21 abnormalities is the world’s best-selling EGFR inhibitor, with $7.25 billion in global sales in 2025. “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 tumors carry exon 20 insertion mutations,” AZ’s oncology hematology business chief, Dave Fredrickson, said in a statement Tuesday. To beef up its EGFR portfolio, AZ also paid $25 million in April to opt in on a preclinical EGFR degrader as part of its collaboration with Pinetree Therapeutics. “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,” Zhang said in a July 14 statement. The two companies go way back. AZ formed Dizal as a joint venture in 2017, transferring to the biotech the R&D capabilities of its Innovation Center China (ICC), along with three preclinical drugs in oncology, cardiometabolic and respiratory diseases. Zhang, an AZ veteran who headed up ICC at the time, became Dizal’s CEO. Even today, AZ is tied with a China state-owned fund in holding the largest stakes in Dizal at a 23.4% share. The British pharma has been on a dealmaking spree in China after committing $15 billion in its investment in the country through 2030 earlier this year. In two back-to-back transactions announced last week, AZ penned a potential $1.75 billion kidney disease pact with CSPC Pharmaceutical and obtained ex-China rights to Sino Biopharmaceutical’s late-phase challenger to Merck & Co.’s chronic obstructive pulmonary disease (COPD) drug Ohtuvayre in a potential $2.1 billion deal.

Dizal grants AstraZeneca worldwide rights to develop and commercialise Zegfrovy Dizal will receive an upfront payment of $600M, and milestone payments of up to $900M. Additionally, Dizal will receive tiered royalties on the global sales of Zegfrovy. SHANGHAI, July 14, 2026 /PRNewswire/ -- Today, Dizal announced that it has entered into a global exclusive license agreement with AstraZeneca for Zegfrovy (sunvozertinib), a novel oral irreversible epidermal growth factor receptor (EGFR) inhibitor for patients with lung cancer. AstraZeneca will acquire worldwide rights to develop and commercialise Zegfrovy. Zegfrovy is approved in China and the U.S. for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. Dizal recently announced results of the multinational Phase III WU-KONG28 study of Zegfrovy in first line NSCLC with EGFR exon20ins mutations. 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. Supported by these results, a Supplemental New Drug Application for approval in the 1st-line setting has been submitted to the China's Center for Drug Evaluation (CDE) and US Food and Drug Administration (FDA). The China's CDE and US FDA have also both granted Breakthrough Therapy Designation to Zegfrovy in this setting. Approximately 80-85% of lung cancer patients globally have NSCLC. About 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia, have EGFR mutations as a disease driver. Roughly one in four patients with an EGFR-mutated NSCLC mutation has a tumor with an exon 20 insertion mutation or other atypical mutation for which targeted treatment options are limited. Dr. Xiaolin Zhang, Chief Executive Officer of Dizal said: "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." 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." Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, 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. With this agreement, we will bring a differentiated, oral targeted treatment to these patients with limited options across the globe." Financial considerations AstraZeneca will make an upfront payment to Dizal of $600m and additional payments of up to $900m upon achievement of specific development, regulatory and sales-related milestones. Additionally, Dizal will receive tiered royalties on the global sales of Zegfrovy. The transaction is expected to close in the second half of 2026, subject to customary closing conditions and regulatory clearances. About Zegfrovy Zegfrovy is an irreversible EGFR inhibitor targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. Zegfrovy is approved in the U.S. and China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy. The approval in China is based on the results of the pivotal WU-KONG6 study in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The U.S. approval is supported by WU-KONG1 Part B, a multinational pivotal study investigating the efficacy and safety of Zegfrovy in the same indication. The sNDA for previously untreated NSCLC with EGFR exon20ins has been submitted to China Center for Drug Evaluation (CDE) and US Food and Drug Administration (FDA), supported by WU-KONG28 study results. The China's CDE and US FDA have also both granted Breakthrough Therapy Designation to Zegfrovy in this setting. In addition, Zegfrovy also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations, as well as HER2 exon20ins. Zegfrovy showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse events) were Grade 1/2 in nature and clinically manageable. About Dizal Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. Dizal's late-stage portfolio includes two approved drugs and three investigational drugs in late-stage development. ZEGFROVY is approved in both the U.S. and China, for the treatment of NSCLC with EGFR exon20ins. Golidocitinib is approved in China for the treatment of relapsed and refractory peripheral T cell lymphoma. Birelentinib, a BBB-penetrant LYN/BTK dual inhibitor, is currently in pivotal studies for various hematological diseases. DZD6008, a 4th generation EGFR TKI, and GW5282 are in post Proof-of-Concept studies. To learn more about Dizal, please visit , or follow us on LinkedIn or X. SOURCE Dizal 21% more press release views with Request a Demo