Sunvozertinib Granted Priority Review by China NMPA for the Treatment of EGFR Exon20ins Mutation Positive Lung Cancer

“NSCLC patients with EGFR exon20ins mutations deserve more effective and safer therapies. Chemotherapies are the current standard of care, and no targeted drug is granted full approval in the world. Multiple clinical studies have shown that Sunvozertinib can bring tremendous benefits to our patients with its superior efficacies and safety profiles. We are working closely with the China CDE to bring this novel drug to patients in China as soon as possible.” said Xiaolin Zhang, Ph.D., Chairman and CEO of Dizal.   The Priority Review designation for this application was supported by clinical results from the WU-KONG6 study, a multicenter, single-arm, Phase II pivotal study conducted in China to evaluate the efficacy and safety of sunvozertinib in platinum-pretreated NSCLC patients with EGFR exon20ins mutations. As of July 31, 2022, the confirmed objective response (cORR), as assessed by blinded independent central review (BICR), was 59.8% in advanced NSCLC with EGFR exon20ins mutations after at least one line of platinum-based chemotherapies. The objective response rate for patients with baseline brain metastasis was 48.4%. Similar efficacy was observed in patients with previous amivantamab treatment. The safety profile of sunvozertinib was amenable to long-term treatment. The most common drug related TEAE (treatment emergent adverse event) were diarrhea and rash, the majority of which were Grade 1/2 and clinically manageable. Dizal is developing sunvozertinib as a monotherapy and in combination with other therapies for the treatment of a broad array of NSCLC.   About Priority Review Designation Priority review was established in China to accelerate the market access of innovative drugs with significant clinical value and urgent clinical need. According to the Drug Registration Rules (Bureau Order 27) effective on July 1, 2020, the regulatory authority will prioritize the review process and evaluation resources for applications under priority review, which should expect reduced review and approval time. About Dizal Dizal is a clinical-stage, biopharmaceutical company, dedicated to the discovery and development of differentiated therapeutics for the treatment of cancer and immunological diseases. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio of five clinical-stage assets with two leading assets in global pivotal studies. 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", "intend" and similar expressions, as they relate to Dizal, are intended to identify certain of such 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 in 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. Contacts Investor Relations: [email protected] Business Development: [email protected]

The release as fetched from its publisher. dizalpharma.com ↗