On August 30, 2026, Dizhe Pharmaceuticals (stock code: 688192.SH) announced that its self-developed novel lung cancer targeted drug, Shuvozhe® (shuvotinib), has been accepted by the U.S. Food and Drug Administration (FDA) for a new indication marketing application (sNDA) for the first-line 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).

This application is based on the results of the Phase III international multicenter randomized controlled clinical trial "WU-KONG28". This study aimed to evaluate the efficacy and safety of Shuwozhe® compared to platinum-based doublet chemotherapy in the first-line treatment of EGFR exon20ins NSCLC. The results showed that Shuwozhe® demonstrated a statistically and clinically significant improvement in progression-free survival (PFS) compared to platinum-based doublet chemotherapy. Detailed data have been presented as a Breakthrough Abstract (LBA) oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the *New England Journal of Medicine* (NEJM). Based on the "WU-KONG28" study, the application for marketing authorization of Shuwozhe® for the first-line treatment of EGFR exon20ins NSCLC has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China and included in the priority review and approval process. Previously, both the CDE and the FDA had granted Shuwozhe® "Breakthrough Therapy Designation" for this indication.

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