SHANGHAI, Aug. 21, 2026 /PRNewswire/ -- Dizal (SSE: 688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced today that the latest clinical data on its novel epidermal growth factor receptor (EGFR) inhibitor ZEGFROVY^® (sunvozertinib) in non-small cell lung cancer (NSCLC) will be presented at the 2026 World Conference on Lung Cancer (WCLC) from September 12 to 15 in Seoul, Republic of Korea.

ZEGFROVY is approved in China and the U.S. for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy. In addition, with positive results from WU-KONG28, a multinational randomized Phase 3 study in treatment naïve patients, the Supplemental New Drug Application (sNDA) of ZEGFROVY as first-line treatment has been submitted to China Center for Drug Evaluation (CDE) and the US Food and Drug Administration (FDA). On July 14, Dizal announced that it entered into an exclusive license agreement granting AstraZeneca global rights to develop and commercialize ZEGFROVY. The transaction is expected to close in the second half of 2026.

At WCLC 2026, Dizal will present the latest findings from a study evaluating ZEGFROVY as adjuvant treatment in patients with resected stage IB-IIIB EGFR exon20ins NSCLC. Promising efficacy results strengthen its potential as an earlier treatment option. No new safety signals have been observed. Based on these findings, a randomized pivotal study is ongoing.  

In addition, Dizal will report updated data from a Phase 2 study evaluating ZEGFROVY in combination with Anlotinib as first-line treatment for NSCLC with EGFR sensitizing mutations and co-mutations. This oral chemotherapy-free combination regimen continues to exhibit robust anti-tumor activity and a manageable safety profile.

The details of the presentation are shown below:

About ZEGFROVY^® (sunvozertinib)

ZEGFROVY is an irreversible EGFR inhibitor targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. ZEGFROVY is approved in the U.S. and China for 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 the results of WU-KONG1 Part B, a multinational pivotal study investigating the efficacy and safety of ZEGFROVY in the same indication. The sNDA for ZEGFROVY as first-line treatment in NSCLC patients with EGFR exon20ins has been submitted to the China Center for Drug Evaluation (CDE) and US Food and Drug Administration (FDA), supported by WU-KONG28 study results. Both China CDE and the US FDA have granted Breakthrough Therapy Designation to ZEGFROVY in this setting.

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 events) were Grade 1/2 in nature and clinically manageable.

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. Dizal's late-stage portfolio includes two approved drugs and three investigational drugs in late-stage development. ZEGFROVY is approved in both the U.S. and China, for the treatment of NSCLC with EGFR exon20ins. Golidocitinib is approved in China for the treatment of relapsed and refractory peripheral T cell lymphoma. Birelentinib, a BBB-penetrant LYN/BTK dual inhibhitor, is currently in pivotal studies for various hematological diseases. DZD6008, a 4^th generation EGFR TKI, and GW5282 are in post Proof-of-Concept studies. To learn more about Dizal, please visit www.dizalpharma.com, or follow us on LinkedIn or X.

Forward-Looking Statements

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Contacts

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