Recently, Dizal Medicine announced that it will present multiple latest research achievements in non-small cell lung cancer (NSCLC) at the American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago from May 29 to June 2, 2026. Among them, the results of the international multicenter Phase III clinical study "WU-KONG28" of sunvozertinib (Sunvozhe®) were selected for the Latest Breakthrough Abstract (LBA) oral presentation, becoming the first and currently only study in the EGFR exon 20 insertion mutation (ex20ins) NSCLC treatment field to receive the highest honor of LBA at the ASCO conference.

"WU-KONG28" is an international multicenter Phase III, open-label, randomized controlled clinical study conducted in 16 countries and regions worldwide, covering major countries including China, the United States, and Europe. Dizal previously announced that the "WU-KONG28" study met its primary endpoint and achieved positive top-line results. The results showed that compared to platinum-based doublet chemotherapy, sunvozertinib demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS).

Sunvozertinib is an oral, irreversible, highly selective EGFR tyrosine kinase inhibitor (TKI) targeting multiple EGFR mutation subtypes, effectively covering various EGFR mutation subtypes including classical driver mutations and refractory mutations (ex20ins and PACC mutations). It is currently the only oral targeted drug globally approved in both China and the US and accessible through medical insurance for second-line/later-line treatment of EGFR ex20ins NSCLC, receiving the highest level of consistent recommendation from domestic and international authoritative guidelines.

Simultaneously, Dizal's another core lung cancer pipeline product DZD6008's latest clinical study for previously treated EGFR C797X mutation NSCLC patients will also be presented as an oral report at this conference. As a novel, highly selective, fully blood-brain barrier penetrating fourth-generation EGFR TKI, DZD6008 aims to address the unmet clinical needs after third-generation EGFR TKI resistance. Previous studies showed that DZD6008 demonstrated significant anti-tumor activity and good 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). As of January 2026, in previously treated patients carrying C797X mutations, the objective response rate (ORR) reached 60%, with median PFS exceeding 10 months (current standard treatment approximately 4-5 months).

Additionally, Dizal will present a poster at the conference showing the latest research progress of golixitinib (Gaoruizhe®) combined with anti-PD-1 antibody for first-line treatment of NSCLC without driver gene mutations. Golixitinib is the world's first and only highly selective JAK1 inhibitor approved for T-cell lymphoma. Preclinical studies show that JAK inhibitors reverse T-cell exhaustion, improve the tumor immune microenvironment, and combined with immunotherapy, can potentially reverse PD-1 inhibitor resistance, providing a mechanistic basis for golixitinib combined with anti-PD-1/PD-L1 therapy.

Summary

Sunvozertinib's key Phase III study being selected for LBA oral presentation is highly anticipated by the industry. EGFR ex20ins mutation has always been a challenging 'difficult-to-treat target' in lung cancer targeted therapy, with multiple similar international studies previously encountering bottlenecks or failures. Sunvozertinib has shown great potential to disrupt the first-line treatment landscape.

Dizal's multiple innovative achievements being presented at ASCO not only reflect the company's continuous breakthroughs and iterative capabilities in the NSCLC treatment field but also demonstrate the international academic community's deep recognition of its innovative pipeline's clinical value. We look forward to Dizal further accelerating the global development process of its core products and promoting the continuous transformation of China's source innovation into clinical benefits for global patients.