# Dizal's ZEGFROVY® (Sunvozertinib) New Drug Application Accepted and Granted Priority Review by China National Medical Products Administration for First-Line Treatment of EGFR Exon 20 Insertion-Mutated Non-Small Cell Lung Cancer

- Link: https://www.thailand-business-news.com/pr-news/dizals-zegfrovy-sunvozertinib-new-drug-application-accepted-and-granted-priority-review-by-china-national-medical-products-administration-for-first-line-treatment-of-egfr-exon-20-inserti
- Published: 2026-05-27T17:40:00+07:00
- Author: PR Newswire

|   |

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 DizalDizal 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](http://www.dizalpharma.com/),
or follow us on [LinkedIn](http://www.linkedin.com/company/dizal-pharma) or [X](https://twitter.com/Dizal_Global).

**Forward-Looking StatementsThis news release may contain certain forward-looking
statements that are, by their nature, subject to significant risks and uncertainties.
The words "anticipate", "believe", "estimate", "expect", and "intend" and similar
expressions, as they relate to Dizal, are intended to identify certain forward-looking
statements. Dizal does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions,
expectations, estimates, projections, and understandings of the management of Dizal
with respect to future events at the time these statements are made. These statements
are not a guarantee of future developments and are subject to risks, uncertainties,
and other factors, some of which are beyond Dizal’s control and are difficult to
predict. Consequently, actual results may differ materially from information contained
in the forward-looking statements as a result of future changes or developments 
in our business, Dizal’s competitive environment, and political, economic, legal,
and social conditions.

Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct
or update the forward-looking statements contained on this site; and (b) no liability
in the event that any of the forward-looking statements does not materialize or 
turn out to be incorrect.

**ContactsInvestor Relations: [ir@dizalpharma.com](https://www.thailand-business-news.com/pr-news/ir@dizalpharma.com)

Business Development: [bd@dizalpharma.com](https://www.thailand-business-news.com/pr-news/bd@dizalpharma.com)
Media Contact: [pr@dizalpharma.com](https://www.thailand-business-news.com/pr-news/pr@dizalpharma.com)

---

  |  This article was produced by Cision PR Newswire, our trusted news partner. The views expressed and the content presented here are solely those of the author and may not fully reflect the opinions of Thailand Business News. |

---

 
**Read the original article :** [Dizal's ZEGFROVY® (Sunvozertinib) New Drug Application Accepted and Granted Priority Review by China National Medical Products Administration for First-Line Treatment of EGFR Exon 20 Insertion-Mutated Non-Small Cell Lung Cancer ](http://www.prnasia.com/story/archive/4967139_CN67139_0?rand=184833)