- Shuwozhe® becomes the world’s first and currently only oral targeted drug to receive NDA acceptance and priority review in the first-line treatment of EGFR exon20ins NSCLC
Previously, Shuwozhe® received conditional and accelerated approvals in China and the U.S., respectively, for second-line or later monotherapy in treating EGFR exon20ins NSCLC. This application is based on positive results from the open-label, randomized, controlled, international multicenter Phase III confirmatory study “WU-KONG28.” The study aims to evaluate the efficacy and safety of Shuwozhe® compared with platinum-based doublet chemotherapy in the first-line treatment of EGFR exon20ins NSCLC and has met its primary endpoint. Compared with platinum-based doublet chemotherapy, Shuwozhe® demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS). Detailed data will be presented as a Late-Breaking Abstract (LBA) oral report at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.
Dr. Xiaolin Zhang, Founder, Chairman, and CEO of Dizal Pharmaceutical, stated: “The NDA acceptance and priority review by the National Medical Products Administration for Shuwozhe® in the first-line treatment of EGFR exon20ins NSCLC marks a significant milestone in our efforts to bring this drug to patients worldwide, highlighting the full-chain support from Chinese regulatory authorities for innovative drugs. Based on the positive results from the WU-KONG28 study, we believe Shuwozhe® has the potential to become a practice-changing treatment option, addressing unmet clinical needs in this therapeutic area. We are also actively advancing registration efforts in other major global markets to benefit more patients worldwide as soon as possible.”
EGFR exon20ins mutations are recognized as a challenging target in NSCLC treatment. Due to their unique spatial conformation, traditional EGFR TKIs struggle to bind to this target, making drug development difficult. Currently, first-line treatment for EGFR exon20ins NSCLC primarily relies on chemotherapy-based regimens, with a long-standing lack of safe, effective, convenient, and chemotherapy-free oral targeted therapies in clinical practice.
Globally, no oral targeted drug has been approved for the first-line treatment of EGFR exon20ins NSCLC. Previously, regulatory authorities in China and the U.S. granted Shuwozhe® Breakthrough Therapy Designation (BTD) for first-line monotherapy in treating EGFR exon20ins NSCLC.
Note: Statements regarding market position and terms such as “first” and “only” in this article are based on publicly available information compiled as of the publication date of this article.
About Shuwozhe® (Sunvozertinib)
Shuwozhe® is an oral, irreversible, highly selective EGFR tyrosine kinase inhibitor (TKI) targeting multiple EGFR mutation subtypes. Its first indication received conditional approval in China in August 2023 through priority review by the National Medical Products Administration for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring 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, Shuwozhe® was included as the only Category I recommended regimen for second-line or later 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), and subsequently included in other major Chinese NSCLC authoritative guidelines with the highest level of recommendation. The approved indication for Shuwozhe® has been included in the National Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance Drug List (2024 Edition). In July 2025, Shuwozhe® received accelerated approval from the U.S. Food and Drug Administration (FDA) through priority review for second-line or later treatment of EGFR exon20ins NSCLC, and 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 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 hematological diseases. The company adheres to a source-innovation R&D philosophy, aiming to introduce first-in-class drugs and breakthrough potential treatments to address unmet global clinical needs. Based on its industry-leading translational science and novel drug molecular design and screening technology platforms, the company has established a pipeline of seven globally competitive products. Among them, two leading products that have met primary endpoints in global pivotal clinical trials—Shuwozhe® has been approved in both China and the U.S., and Gaoruizhe® has been approved in China. For more information, please follow the WeChat public account: Dizal Dizal, or visit www.dizalpharma.com.
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