Dizal Announces China CDE Approval of IND application for Phase 2 Study of Sunvozertinib in Combination with Golidocitinib for Non-Small Cell Lung Cancer

Dizal announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved an investigational new drug (IND) application for the company's leading assets, sunvozertinib in combination with golidocitinib for EGFR-mutant non-small cell lung cancer (NSCLC). The multi-center, Phase 2 clinical trial has been designed to evaluate the safety, tolerability and efficacy of sunvozertinib, a highly selective EGFR TKI, in combination with golidocitinib, a JAK1 specific inhibitor, in treating patients with EGFR-mutant NSCLC who failed standard of care. While significant advancements have been made in the targeted therapies for metastatic NSCLC, acquired resistance remains a major barrier to treatment. The available findings suggest that the JAK/STAT pathway modulates the response and resistance to EGFR TKI, and dual inhibition of EGFR and JAK/STAT signaling pathway can be a potential therapeutic target to enhance the efficacy of EGFR TKIs in patients with EGFR-mutant NSCLC. Preclinical studies demonstrated that sunvozertinib in combination with golidocitinib showed synergistic anti-tumor effects in NSCLC xenograft models with EGFR sensitising mutations and/or drug-resistant mutations, consistent with the scientific hypothesis. "Patients with EGFR-mutant lung cancers can develop resistance to EGFR inhibitors, and have limited treatment options to move forward.” said Xiaolin Zhang, Ph.D., Chairman and CEO of Dizal. "The preclinical proof-of-concept data reveal the potential of the combination of sunvozertinib and golidocitinib to offer clinical benefit to this underserved population plagued by resistance. We will accelerate the clinical trial with an endeavor to provide potential new treatment modalities to address the next stage of disease.” About sunvozertinib (DZD9008) Sunvozertinib was designed with the goal to address the limitations of existing NSCLC therapies. It is an irreversible inhibitor targeting EGFR exon 20 insertion mutations as well as EGFR sensitising T790M and uncommon mutations while maintaining selectivity against wild-type EGFR. The first pivotal study WU-KONG6 of sunvozertinib has achieved its primary endpoint, demonstrating superior antitumor efficacy in pre-treated NSCLC patients with EGFR exon20 insertion mutations. The confirmed ORR (cORR) at 300 mg was 59.8% by BICR. Patients with baseline brain metastasis showed significant response as well, with a confirmed ORR of 48.4%. (Data cut-off date: July 31, 2022). It is well tolerated with a manageable AE profile. Global pivotal studies of sunvozertinib in patients with advanced NSCLC with EGFR exon20ins in the 1st line and ≥ 2nd line setting are ongoing. About Golidocitinib (DZD4205) Golidocitinib (DZD4205), which was granted Fast Track Designation by US FDA, is an oral, potent, JAK1 specific inhibitor. Results from the Phase 1/2 trial, which is evaluating the efficacy and safety of golidocitinib in patients with r/r PTCL, showed golidocitinib yielded an ORR of 42.9%. This data was accepted as an encore oral presentation at EHA 2022. 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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