- Sunvozertinib® becomes the first and only drug in the EGFR exon20ins NSCLC treatment field globally to receive the highest honor of an LBA presentation at the ASCO conference
- The latest clinical study on the fourth-generation EGFR TKI DZD6008 for pretreated EGFR C797X-mutated NSCLC patients has been selected for an ASCO oral presentation
At this conference, the results of the international multicenter Phase III clinical study “WU-KONG28” for Sunvozertinib® were selected for a Late-Breaking Abstract (LBA) oral presentation. This makes it the first and only drug globally in the treatment of epidermal growth factor receptor (EGFR) exon 20 insertion mutation (exon20ins) non-small cell lung cancer (NSCLC) to receive the highest honor of an LBA presentation at the ASCO conference. The company had previously announced that the “WU-KONG28” study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for Sunvozertinib® compared to platinum-based doublet chemotherapy.
Sunvozertinib® is an oral, irreversible, highly selective EGFR tyrosine kinase inhibitor (TKI) targeting multiple EGFR mutation subtypes. It effectively covers various EGFR mutation subtypes, including classical driver mutations and refractory mutations (exon20ins and PACC mutations). It is currently the only oral targeted drug for second-/later-line treatment of EGFR exon20ins NSCLC that is approved in both China and the United States and accessible via medical insurance, receiving the highest-level unanimous recommendation from authoritative guidelines both domestically and internationally.
Simultaneously, the latest clinical study on DZD6008 for pretreated EGFR C797X-mutated NSCLC patients will also be presented as an oral report at this conference. As a novel, highly selective, fourth-generation EGFR TKI capable of fully penetrating the blood-brain barrier, DZD6008 aims to address the unmet clinical need following resistance to third-generation EGFR TKIs. Previous studies have shown that DZD6008 exhibits significant anti-tumor activity and favorable safety against various EGFR mutations, including sensitive mutations (L858R/19del), resistant double mutations (L858R/19del and T790M/C797X), or triple mutations (L858R/19del, T790M, and C797X).
Furthermore, the company will present the latest research progress on Golidocitinib® combined with an anti-PD-1 antibody as first-line treatment for NSCLC without driver gene mutations. Golidocitinib® is the first and only highly selective JAK1 inhibitor globally approved for T-cell lymphoma. Preclinical studies indicate that JAK inhibitors can reverse T-cell exhaustion, improve the tumor immune microenvironment, and potentially reverse PD-1 inhibitor resistance when combined with immunotherapy, providing a mechanistic basis for Golidocitinib® combined with anti-PD-1/PD-L1 therapy.
Dr. Xiaolin Zhang, Founder, Chairman, and CEO of Dizal Pharma, stated: “The presentation of multiple innovative achievements by our company at this ASCO conference, especially the selection of the key Phase III study for Sunvozertinib® for the LBA session, not only reflects our company’s continuous breakthroughs and iterative capabilities in the field of NSCLC treatment but also demonstrates the deep recognition by the international academic community of the clinical value of our innovative pipeline. In the future, we will accelerate the clinical development and global deployment of our core products to swiftly translate China’s source innovation into benefits for patients worldwide.”
Information on the selected 2026 ASCO research abstracts is as follows:
- Abstract Title:
Sunvozertinib monotherapy versus platinum-based chemotherapy as first-line treatment for advanced NSCLC with EGFR exon20ins: Primary analysis of a multinational phase 3 randomized study (WU-KONG28)
Abstract Number: LBA8500
Principal Investigator: John Heymach (MD Anderson Cancer Center, USA)
LBA Oral Presentation Time: 5/29/2026, 1:00 PM-4:00 PM (Central Daylight Time, USA)
- Abstract Title:
DZD6008, a 4th Generation EGFR TKI, in Pretreated NSCLC Patients with EGFR C797X Mutations: Results from Phase 1/2 Studies.
Abstract Number: 8520
Principal Investigator: Professor Mengzhao Wang (Peking Union Medical College Hospital)
Oral Presentation Time: 5/30/2026, 1:15 PM-2:45 PM (Central Daylight Time, USA)
- Abstract Title:
Combination of golidocitinib (a JAK1 inhibitor) with anti–PD-1 antibody to improve tumor response and patient quality of life: Preliminary results from an ongoing JACKPOT 33 study
Abstract Number: 8555
Principal Investigator: Professor Jie Wang (Cancer Hospital, Chinese Academy of Medical Sciences)
Poster Presentation Time: 5/31/2026, 9:00 AM-12:00 PM (Central Daylight Time, USA)
Note: Descriptions regarding market position, “first and only,” etc., are based on publicly available data as of the date of this release.
About Sunvozertinib® (Sunvozertinib Tablets)
Sunvozertinib® is an oral, irreversible, highly selective EGFR tyrosine kinase inhibitor (TKI) targeting multiple EGFR mutation subtypes. Its first indication was approved for marketing in China in August 2023 by the National Medical Products Administration (NMPA) through a priority review. It is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have disease progression on or intolerance to prior platinum-based chemotherapy and whose tumors have confirmed epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins). In April 2024, Sunvozertinib® was included as the only Category I recommended regimen for second-/later-line treatment of EGFR exon20ins NSCLC in the “Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Non-Small Cell Lung Cancer (2024 Edition).” Subsequently, it has been included in other major authoritative NSCLC guidelines in China with the highest-level recommendations. The approved indication for Sunvozertinib® has been included in the “National Reimbursement Drug List (2024).” In July 2025, Sunvozertinib® for second-/later-line treatment of EGFR exon20ins NSCLC was approved for marketing in the United States by the U.S. Food and Drug Administration (FDA) through a priority review procedure. It has since been included in the recommendations of the National Comprehensive Cancer Network (NCCN) Guidelines and the American Society of Clinical Oncology (ASCO) Guidelines, becoming the only small molecule targeted drug for EGFR exon20ins NSCLC included in both major international authoritative lung cancer guidelines.
About Golidocitinib® (Golidocitinib Capsules)
Golidocitinib® is a highly selective Janus kinase 1 (JAK1) inhibitor independently developed by Dizal. It is the first and only globally approved novel mechanism treatment drug targeting the JAK/STAT pathway for PTCL. It was first approved for marketing in China in June 2024 by the NMPA, indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) who have received at least one prior line of systemic therapy. The approved indication for Golidocitinib® has been included in the “National Reimbursement Drug List (2024).” In April 2025, Golidocitinib® for the treatment of r/r PTCL was included as a Category I recommended regimen in the “Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Lymphoma (2025 Edition).”
About DZD6008
DZD6008 is a novel, fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) independently developed by the company that can fully penetrate the blood-brain barrier. It effectively inhibits the growth of various EGFR-mutated cells and tumor animal models. Currently, the resistance mechanisms to EGFR TKIs in non-small cell lung cancer (NSCLC) are not fully understood, and existing treatment options offer limited clinical benefit. Meanwhile, brain metastasis is one of the main causes of disease progression and patient death. Approximately 23%-30% of EGFR-mutated NSCLC patients have brain metastases at initial diagnosis, and the risk of brain metastasis may increase to 29.4%-60.3% within 3 years after diagnosis.
Currently, existing treatment options for NSCLC resistant to third-generation EGFR TKIs offer limited clinical benefit. DZD6008 is expected to address the unmet clinical need in this field. In completed clinical trials, DZD6008 has fully validated its design concept, demonstrating excellent safety and efficacy in patients who have failed third-generation EGFR TKI therapy and multiple lines of treatment, including those with brain metastases.
About Dizal Pharma
Dizal Pharma (Stock Code: 688192.SH) is an innovative biopharmaceutical company focused on the research, development, and commercialization of innovative therapies for malignant tumors and immune diseases. Adhering to a source innovation R&D philosophy, the company aims to develop global first-in-class drugs and breakthrough potential treatments to address unmet clinical needs worldwide. Leveraging industry-leading translational science and novel drug molecule design and screening technology platforms, the company has established a pipeline of seven globally competitive products. Among them, two leading products whose global pivotal clinical trials have met their primary endpoints – Sunvozertinib® has been approved for marketing in China and the United States, and Golidocitinib® has been approved for marketing in China. For more information, please follow the WeChat official account: Dizal, or visit www.dizalpharma.com.
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