• Pivotal Phase 3 WU-KONG28 Study of ZEGFROVY^® selected as Late-Breaking Abstract
• Oral presentation for DZD6008, the 4^th generation EGFR TKI, in EGFR mutated NSCLC after Tagrisso and other 3^rd generation EGFR TKI treatment
• Poster presentation on clinical benefits of golidocitinib in combination with PD-1

SHANGHAI, April 21, 2026 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for cancer and immunological diseases, today announced that new clinical data from its non-small cell lung cancer (NSCLC) pipeline will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29–June 2 in Chicago. The presentations will feature the company's investigational assets ZEGFROVY^® (sunvozertinib), golidocitinib, and DZD6008, highlighted by two oral presentations, including one selected as a Late-Breaking Abstract (LBA).

Results from the multinational Phase 3 WU-KONG28 study of ZEGFROVY have been selected for oral presentation as an LBA. ZEGFROVY is an oral, irreversible, and highly selective EGFR tyrosine kinase inhibitor (TKI), approved in China and the U.S. for the treatment of relapsed or refractory NSCLC harboring EGFR exon20ins. WU-KONG28 is a phase 3 randomized pivotal study comparing sunvozertinib vs. chemo doublet in previously untreated NSCLC patients with EGFR exon20ins mutation. Earlier, Dizal announced that the study had met its primary endpoint with statistically significant and clinically meaningful improvement in progression-free survival (PFS).

Updated clinical data of DZD6008 in pretreated NSCLC patients with EGFR C797X mutations have also been selected for oral presentation. DZD6008 is a novel, highly selective fourth-generation EGFR TKI with full blood-brain barrier (BBB) penetration, designed to address clinical challenges after treatment failure from third-generation EGFR TKIs. In preclinical models, DZD6008 exhibits potent and consistent inhibitory activity across a broad range of EGFR mutations, including EGFR driver mutations (L858R and exon 19 deletions), resistant double mutations (including T790M/C797S in the context of L858R or exon 19 deletion), and the challenging triple mutations (C797X plus T790M plus L858R or exon 19 deletion).

In addition, Dizal will present the latest findings from a study evaluating golidocitinib in combination with anti–PD-1 antibody in NSCLC without known driver mutations. Golidocitinib is the world's first and only approved JAK1 inhibitor for relapsed or refractory peripheral T-cell lymphoma. Preclinical data indicate that JAK inhibition can rescue exhausted T-cell function and modulate the tumor microenvironment, providing a mechanistic basis for the combination of golidocitinib with anti-PD-1/PD-L1 therapies in NSCLC patients who have progressed on prior anti-PD-1 containing regimens.

Dr. Xiaolin Zhang, CEO of Dizal, said: "The new data to be reported at ASCO 2026 show significant progress we have made with our non-small cell lung cancer (NSCLC) pipeline. We are especially happy to report that WU-KONG28 met its primary endpoint. EGFR exon20ins is a tough target, and several compounds have failed in clinical studies. With this positive study, Zegfrovy further demonstrates its potential as the treatment of choice for newly diagnosed lung cancer patients with EGFR exon20ins mutation."

Dizal presentation details during 2026 ASCO:

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 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 Cancer Discovery, The Lancet Respiratory Medicine and Journal of Clinical Oncology.

About Golidocitinib (DZD4205)

Golidocitinib is currently the first and only Janus kinase 1 (JAK1) inhibitor being evaluated for the treatment of r/r PTCL. In June 2024, golidocitinib was approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL).

At the date of August 31, 2023, golidocitinib demonstrated robust and durable anti-tumor efficacy, with an ORR of 44.3%. All subtypes benefited well, and the ORR of common subtypes exceeded 40%. More than 50% of the patients with tumor remission achieved a complete response with a CRR of 23.9%. Per IRC assessment, the median duration of response (mDoR) reached 20.7 months. As of February 2024, golidocitinib showed a median overall survival (mOS) of 24.3 months.

Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted its NDA and granted Priority Review for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8 PART A) were published in Annals of Oncology (Impact Factor: 51.8), and global pivotal trial data of golidocitinib for the treatment of r/r PTCL (JACKPOT PART B) were published in The Lancet Oncology (Impact Factor: 54.4).

About DZD6008

DZD6008 is a novel, highly selective, full-BBB penetrant EGFR TKI, designed as a potential treatment option for advanced EGFR mutation positive (EGFRm) NSCLC.

Non-small cell lung cancer is the leading cause of cancer death in the world. Epidermal growth factor receptor (EGFR) gene is one of the most common driver genes for NSCLC. Multiple agents can be used to treat patients with EGFR mutated NSCLC who develop resistance to EGFR tyrosine kinase inhibitors (TKIs), but the clinical outcome was not satisfactory. Brain metastases (BM) are a leading cause of death and disease progression for NSCLC. Approximately 23%-30% of NSCLC patients are synchronous BM at their initial diagnosis. Previous studies reported that the 3-year cumulative rate of BMs ranges from 29.4% to 60.3% in patients with mutated EGFR.

Currently, the clinical benefits of existing treatments for third-generation EGFR TKI-resistant NSCLC are limited and DZD6008 is expected to fill the unmet medical needs. DZD6008 effectively inhibits EGFR-mutated tumor growth in cell lines and in animal models. Previous clinical studies have validated the design concept of the molecule and suggest that DZD6008 demonstrates good safety and efficacy in NSCLC patients with brain metastases who had failed third-generation EGFR TKI therapy or multiple lines of pre-treatments.

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 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, or follow us on Linkedin or X.

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: ir@dizalpharma.com
Business Development: bd@dizalpharma.com
Media Contact: pr@dizalpharma.com 

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