China grants priority review to Dizal’s Zegfrovy for first-line EGFR exon 20 insertion NSCLC

Edited by Robert McTiernan··3 min read

Dizal Pharmaceutical (SSE: 688192), a Shanghai-based biopharmaceutical company, has submitted a New Drug Application to China’s National Medical Products Administration (NMPA) for Zegfrovy (sunvozertinib) in the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR exon 20 insertion mutations. The NMPA’s Center for Drug Evaluation has accepted the application and granted it priority review.

The submission is a supplemental NDA, extending the existing regulatory record for sunvozertinib into the first-line setting. Zegfrovy already holds accelerated approval in both China and the US for patients with EGFR exon 20 insertion-mutated NSCLC whose disease has progressed on or after platinum-based chemotherapy. The new filing seeks approval for treatment-naive patients, representing a materially broader population and an earlier intervention point.

The NMPA’s priority review designation reflects the agency’s assessment that the application addresses a clinical need without an adequate existing solution. No PDUFA-equivalent timeline has been disclosed by Dizal, and the company said it is working to submit applications to additional regulatory agencies globally.

The application is supported by data from WU-KONG28, a multinational, randomized Phase III study evaluating sunvozertinib against a platinum-containing chemotherapy doublet as first-line treatment in patients with advanced NSCLC harboring EGFR exon 20 insertion mutations. The trial was conducted across 16 countries and regions. The company said the study met its primary endpoint, with a statistically significant improvement in progression-free survival compared to chemotherapy. Detailed results are scheduled for presentation as a late-breaking oral abstract at the 2026 American Society of Clinical Oncology Annual Meeting.

Earlier approvals in the post-platinum setting were based on separate studies. China’s existing approval rests on WU-KONG6, a single-arm, multicenter Phase II study. The US accelerated approval granted in July 2025 was supported by WU-KONG1 Part B, a multinational, open-label, multicenter Phase I/II study.

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Competitive and scientific context

Sunvozertinib is an irreversible EGFR inhibitor designed to target a broad spectrum of EGFR mutations, including exon 20 insertions, while maintaining selectivity over wild-type EGFR — a property intended to reduce the dermatologic and gastrointestinal toxicities associated with earlier-generation TKIs that lack this discrimination.

The filing enters a first-line landscape currently defined by a single approved regimen: amivantamab-vmjw (Rybrevant) combined with carboplatin and pemetrexed, which received full FDA approval in March 2024 based on the PAPILLON Phase III trial, developed by Janssen Pharmaceutical. That combination demonstrated a meaningful improvement in progression-free survival over chemotherapy alone but requires intravenous administration and retains the toxicity burden of platinum-based chemotherapy. No oral, chemotherapy-free targeted therapy is currently approved for first-line EGFR exon 20 insertion-mutated NSCLC in any jurisdiction.

Sunvozertinib holds Breakthrough Therapy Designations from both the US FDA and China’s CDE for the treatment-naive EGFR exon 20 insertion population, reflecting early regulatory recognition of the clinical rationale for the first-line program. If approved, it would be the first oral monotherapy available at the front line for this molecular subgroup.

The withdrawal of mobocertinib (Exkivity) from the US market in 2023, after its confirmatory EXCLAIM-2 Phase III trial failed to demonstrate superiority over chemotherapy in the first-line setting, established a cautionary precedent for this class and raised the evidentiary bar for subsequent oral TKI programs. Sunvozertinib’s WU-KONG28 data, which the company describes as meeting its primary endpoint in a randomized comparison against chemotherapy, will be subject to detailed scrutiny when the full dataset is presented at ASCO 2026.

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