U.S. FDA Granted Priority Review to Dizal's Sunvozertinib New Drug Application

• If approved, Sunvozertinib as a single oral drug would offer a convenient and safe treatment option with superior efficacy for NSCLC patients with EGFR exon20ins
• Sunvozertinib's NDA was submitted based on the multinational pivotal WU-KONG1 Part B study, the results of which were presented at the 2024 ASCO Annual Meeting

SHANGHAI, Jan. 7, 2025 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the company's New Drug Application (NDA) for sunvozertinib, an oral EGFR inhibitor for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

The FDA grants priority review to drugs that, if approved, would be significant improvements in the safety or effectiveness over existing treatment for a serious disease. This decision follows the FDA's earlier Breakthrough Therapy Designations for Sunvozertinib in treatment naïve and relapsed or refractory settings. Currently, no small molecule drug has been approved in the U.S. or Europe to treat this serious disease.

The NDA submission is supported by efficacy and safety results from the multinational pivotal WU-KONG1 Part B study, evaluating sunvozertinib in relapsed or refractory NSCLC patients with EGFR exon20ins from Asia, Europe, North America, and South America. These data, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrated statistically significant clinical benefits.

"Patients with EGFR exon20ins NSCLC face a poor prognosis and limited treatment options," said Xiaolin Zhang, PhD, CEO of Dizal. "Sunvozertinib's Priority Review designation marks an important regulatory milestone in Dizal's efforts to address unmet medical needs worldwide. The results from the WU-KONG1 Part B study are promising. If approved, sunvozertinib as a single oral drug would offer a convenient and safe treatment option with superior efficacy for NSCLC patients with EGFR exon20ins."

In 2023, Sunvozertinib was granted accelerated approval by the National Medical Products Administration (NMPA) of China, making it the world's first and only oral treatment for NSCLC patients with EGFR exon20ins.

About Sunvozertinib (DZD9008)
Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. The approval is based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins.

Sunvozertinib 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.

Two global pivotal studies are ongoing in ≥ 2nd line (WU-KONG1 Part B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins.

Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery and The Lancet Respiratory Medicine.

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 two approved drugs and multiple assets in global pivotal studies. 

To learn more about Dizal, please visit www.dizalpharma.com, or follow us on Linkedin or Twitter.

Forward-Looking Statements
This 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 turnout to be incorrect.

Contacts
Investor Relations: [email protected]
Business Development: [email protected]
Media Contact: [email protected]