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.