Dizal Announces China CDE Acceptance of New Drug Application for Sunvozertinib for Platinum-Pretreated NSCLC Patients with EGFR Exon20ins Mutations

Dizal today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for sunvozertinib for the treatment of advanced NSCLC with EGFR exon20ins mutations after platinum-based chemotherapies.  Sunvozertinib (DZD9008) is an investigational, best-in-class, oral tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) exon20 insertion (exon20ins) mutations. Sunvozertinib has been granted Breakthrough Therapy Designation by both the US FDA and China CDE.   “This is our first NDA submission, a significant milestone for Dizal. All available data indicates that sunvozertinib is a best-in-class drug with superior efficacy and safety profile. It will provide a much-needed treatment option for Chinese patients. We are doing everything we can to accelerate our global clinical development programs to make it available to cancer patients outside of China as soon as possible.” said Xiaolin Zhang, Ph.D., Chairman and CEO of Dizal. “At Dizal, we are committed to discovering and developing innovative medicines for the benefit of cancer patients globally.”   The NDA submission for sunvozertinib is based on data 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. The primary objective of the study was Objective Response Rate according to RECIST v1.1, with Duration of Response (DOR) as the key secondary objective. As of July 31, 2022, the confirmed objective response (cORR), as assessed by blinded independent central review (BICR), was 59.8% . The objective response rate for patients with baseline brain metastasis was 48.4%. Sunvozertinib showed superior safety profile. The most common drug related TEAEs (treatment emergent adverse event) were Grade 1/2 in nature and clinically manageable. Global pivotal studies of sunvozertinib in patients with advanced NSCLC with EGFR exon20ins in the 1st line and ≥2nd line setting are ongoing. 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]

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