Dizal said China’s Center for Drug Evaluation of the National Medical Products Administration has accepted and granted priority review to a new drug application for ZEGFROVY (sunvozertinib) as first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. The company, which focuses on oncology and hematologic diseases, noted that lung cancers with EGFR exon 20 insertions are difficult to treat due to their high heterogeneity and are currently managed largely with chemotherapy-based regimens.
ZEGFROVY has previously received accelerated approval from both China’s regulator and the U.S. Food and Drug Administration. The latest submission is supported by the WU-KONG28 study, a confirmatory multinational, randomized Phase 3 trial comparing ZEGFROVY to a platinum-based chemotherapy doublet in the first-line setting for EGFR exon 20 insertion–mutated advanced NSCLC. Dizal said the study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival. Detailed WU-KONG28 data are slated for presentation as a Late-Breaking Abstract oral session at the 2026 American Society of Clinical Oncology 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 Xiaolin Zhang, MD, CEO of Dizal. He said the positive WU-KONG28 results support the potential of ZEGFROVY to become a practice-changing option for this underserved group and added that the company is working to submit applications to other regulators worldwide as quickly as possible.
Dizal highlighted that there remains an unmet need for effective, chemotherapy-free, oral targeted therapies for newly diagnosed patients with EGFR exon 20 insertion–mutated NSCLC. Globally, no oral targeted therapies have yet been approved as first-line treatment for this population. ZEGFROVY monotherapy has received Breakthrough Therapy Designation from both the U.S. FDA and China’s CDE for treatment-naïve patients with EGFR exon 20 insertion NSCLC.
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