- Sunvozertinib® International Multi-Center Phase III Study “WU-KONG28” Presented as a Late-Breaking Abstract (LBA) at 2026 ASCO, Simultaneously Published in the New England Journal of Medicine
- Sunvozertinib® is the First and Only Oral Targeted Monotherapy Globally Validated by an International Multi-Center Randomized Controlled Phase III Clinical Study in First-Line Treatment of EGFR exon20ins NSCLC
- Compared with Platinum-Based Doublet Chemotherapy, Sunvozertinib® Monotherapy in First-Line Treatment of EGFR exon20ins NSCLC Demonstrates Significantly Greater Clinical Benefit, Poised to Reshape the Treatment Landscape in This Field
Results from the “WU-KONG28” study showed that, in the first-line treatment of non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), Sunvozertinib® monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) compared with platinum-based doublet chemotherapy. As the first and only oral targeted monotherapy globally validated by a successful international multi-center randomized controlled Phase III clinical study in this field, Sunvozertinib® is expected to reshape the first-line treatment landscape for EGFR exon20ins NSCLC.
As of January 16, 2026, a total of 324 patients worldwide were randomized 1:1 into the Sunvozertinib® group and the chemotherapy group. Study results showed that, at a dose of 300 mg once daily, Sunvozertinib® monotherapy in first-line treatment of EGFR exon20ins NSCLC achieved potent tumor shrinkage with a manageable safety profile, potentially best-in-class globally:
- As assessed by the Blinded Independent Review Committee (BIRC), the median PFS for Sunvozertinib® was 10.3 months, compared with 7.5 months in the chemotherapy group, demonstrating a statistically significant and clinically meaningful improvement (HR=0.65; P=0.0008);
- As assessed by BIRC, the best objective response rate (BoR) in the Sunvozertinib® group was 68.1% (vs. 35.4% in the chemotherapy group), and the median duration of response (DoR) was 11.2 months (vs. 7.1 months in the chemotherapy group), both showing significant improvements over chemotherapy;
- Overall safety was favorable, consistent with previous studies, with adverse events generally manageable and reversible.
Professor Caicun Zhou from Shanghai East Hospital, Tongji University, Global Lead Investigator of “WU-KONG28,” Corresponding Author and First Author of the New England Journal of Medicine article, stated: “Currently, first-line treatment for non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations (exon20ins) still relies on chemotherapy-based regimens, and patients have long lacked a precision targeted therapy that combines efficacy, safety, and treatment convenience. The ‘WU-KONG28’ study shows that, compared with platinum-based doublet chemotherapy, Sunvozertinib® monotherapy in first-line treatment of EGFR exon20ins NSCLC demonstrates superior antitumor efficacy, along with favorable safety and treatment convenience. This result is expected to reshape the current treatment landscape, ushering the first-line treatment of EGFR exon20ins NSCLC into the ‘chemotherapy-free era’ and offering global patients a new, more precise, and convenient targeted monotherapy option.”
Dr. Xiaolin Zhang, Founder, Chairman, and CEO of Dizal Pharmaceutical, said: “The presentation of ‘WU-KONG28’ study data as an LBA at the ASCO conference and its simultaneous publication in the New England Journal of Medicine fully demonstrate that its research quality and clinical value have received high recognition from international authorities. Drug development in the first-line treatment of non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations (exon20ins) is extremely challenging. As the first international multi-center randomized controlled Phase III study globally to confirm the efficacy of an oral targeted monotherapy in this field, ‘WU-KONG28’ has validated the superior clinical benefit of Sunvozertinib® worldwide, potentially providing global patients with a new ‘chemotherapy-free’ treatment option. The successful delivery of this, Dizal’s first global Phase III study, not only reflects our ongoing ability to drive source innovation and high-quality global clinical development but also highlights the growing international academic influence of Chinese scientist teams in the field of precision lung cancer treatment. We sincerely thank all patients, families, and investigators involved in the study for their trust and dedication, and we are deeply proud of our team’s extraordinary achievement.”
Previously, Sunvozertinib® was approved in both China and the United States for second-line or later-line monotherapy treatment of EGFR exon20ins NSCLC, becoming the only oral targeted drug in this field approved in both countries, covered by medical insurance, and consistently recommended at the highest level by authoritative domestic and international guidelines. Based on the positive results of the “WU-KONG28” study, a New Drug Application (NDA) for a new indication of Sunvozertinib® in first-line treatment of EGFR exon20ins NSCLC has been accepted by the National Medical Products Administration (NMPA) and granted priority review status.
Note: Statements regarding market position, “first and only,” etc., in this article are based on publicly available data as of the date of this publication.
About Sunvozertinib®
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 through priority review, for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) who have progressed on or are intolerant to prior platinum-based chemotherapy. In April 2024, Sunvozertinib® was included as the only Level I recommended regimen for second-line or 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 was included in other major Chinese NSCLC authoritative guidelines with the highest level of recommendation. The approved indication for Sunvozertinib® has been included in the National Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance Drug Catalog (2024 Edition). In July 2025, Sunvozertinib® was approved for marketing in the United States by the U.S. Food and Drug Administration (FDA) through priority review for second-line or later-line treatment of EGFR exon20ins NSCLC, and it has been successively included in 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 “WU-KONG28”
“WU-KONG28” is an open-label, randomized controlled, international multi-center Phase III confirmatory study conducted across 15 countries and regions worldwide, covering major countries in China, the United States, and Europe. It aims to evaluate the efficacy and safety of Sunvozertinib® compared with platinum-based doublet chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) who are newly diagnosed or have not received prior systemic therapy.
About Dizal Pharmaceutical
Dizal Pharmaceutical (Stock Code: 688192.SH) is a global innovative biopharmaceutical company focused on the research, development, and commercialization of innovative therapies in the fields of oncology and hematologic diseases. The company adheres to a source innovation R&D philosophy, aiming to introduce first-in-class drugs and treatments with breakthrough potential to fill unmet global clinical needs. Based on its industry-leading translational science and novel drug design and screening technology platforms, the company has established a pipeline of seven globally competitive product candidates. Among them, two leading products that have met primary endpoints in global pivotal clinical trials—Sunvozertinib® has been approved for marketing in both China and the United States, and Golidocitinib® has been approved for marketing in China. For more information, please follow the WeChat public account: Dizal, or visit www.dizalpharma.com.
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