DiZhe Pharmaceutical: The NDA for Shuwozhe frontline treatment of non-small cell lung cancer has been accepted, making it the first in the world.

Dicell Pharmaceuticals announced that the new drug application for their independently developed drug Shuwuzhe with a new indication has been formally accepted by the National Medical Products Administration Drug Evaluation Center and included in the priority review process. It is intended for adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon20ins mutation. This application is currently the world's first and only oral targeted drug for EGFR exon20ins NSCLC in the first-line treatment field to be accepted for NDA and included in priority review. The application is based on the positive results of the open label, randomized controlled, international multicenter phase III confirmatory study "Wukong28," which showed significant and clinically meaningful improvement in progression-free survival compared to platinum-based doublet chemotherapy. Detailed data will be presented in the form of a new breakthrough abstract oral presentation at the 2026 American Society of Clinical Oncology Annual Meeting.