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SHANGHAI, May 27, 2026 /PRNewswire/ — Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of oncology and hematological diseases, announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted and granted priority review to the New Drug Application (NDA) for ZEGFROVY® (sunvozertinib) 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).
ZEGFROVY was granted accelerated approval previously by China’s CDE and the U.S. Food and Drug Administration (FDA). The new sNDA is based on the results of WU-KONG28 study, a confirmatory, multinational, randomized phase 3 study evaluating ZEGFROVY versus platinum-containing chemo doublet as first-line treatment in advanced NSCLC patients with EGFR exon20ins. The study met its primary endpoint with statistically significant and clinically meaningful improvement in Progression Free Survival (PFS). The detailed data will be presented as a Late-Breaking Abstract (LBA) oral presentation at the upcoming 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.
“The NDA acceptance and priority review designation for ZEGFROVY in first-line EGFR exon20ins NSCLC is an important step forward for us to make the drug available to our patients globally,” said Dr. Xiaolin Zhang, CEO of Dizal. “Supported by positive results from WU-KONG28, we believe ZEGFROVY has the potential to be a practice-changing drug for this underserved patient population. We are working very hard to submit NDAs to other regulatory agencies globally as soon as possible.”
Lung cancer with EGFR exon20ins are particularly challenging to treat due to its high heterogeneity. Currently, the first-line treatment for EGFR exon20ins NSCLC largely relies on chemotherapy-based regimens. There remains an unmet need for effective, chemotherapy-free, oral targeted therapies for newly diagnosed patients.
Globally, no oral targeted therapies have been approved for the first-line treatment of EGFR exon20ins NSCLC. ZEGFROVY monotherapy has received Breakthrough Therapy Designations (BTDs) from both the U.S. FDA and China’s CDE for this treatment-naïve patient population.
About ZEGFROVY®(sunvozertinib)
ZEGFROVY is an irreversible EGFR inhibitor discovered by Dizal scientists 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.
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 event) were Grade 1/2 in nature and clinically manageable.
WU-KONG28, a multinational, randomized Phase 3 study conducted across 16 countries and regions evaluating ZEGFROVY as first-line treatment for patients with EGFR exon20ins NSCLC, met its primary endpoint.
Pre-clinical and clinical results of ZEGFROVY were published in peer-reviewed journals including Cancer Discovery, The Lancet Respiratory Medicine and Journal of Clinical Oncology.
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. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs worldwide. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio with multiple assets in global pivotal studies and two leading assets: ZEGFROVY, approved in both the U.S. and China, and golidocitinib, approved in China. To learn more about Dizal, please visit www.dizalpharma.com, or follow us on LinkedIn or X.
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