By Fineline Cube 
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) announced the completion of patient enrollment for its global multicenter Phase III clinical trial “WU-KONG28”. The trial evaluates its proprietary lung cancer targeted therapy Shuwozhe (sunvozertinib) versus platinum-based chemotherapy in first-line advanced non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations (exon20ins).
Shuwozhe’s Unique Position
Shuwozhe stands as the world’s only oral targeted therapy for EGFR exon20ins NSCLC. Its excellent efficacy and safety have earned it Breakthrough Therapy Designations (BTDs) in both China and the US across all treatment lines.
Regulatory and Market Milestones
Shuwozhe was approved in China via priority review and included in the National Reimbursement Drug List (NRDL) within its first year. Currently, it is the only NRDL-reimbursed standard treatment for second-/later-line EGFR exon20ins NSCLC and holds top-tier recommendations in all major Chinese clinical guidelines.
US FDA Review
A New Drug Application (NDA) for Shuwozhe for the treatment of second-/later-line EGFR exon20ins NSCLC was accepted for review by the US FDA in January this year with priority review status. The agency is expected to make its decision in early July 2025.-Fineline Info & Tech