Dizhe Pharma announces positive topline results for a new targeted drug for lung cancer, with the CEO stating it is a significant milestone in the company's development

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On March 23, recently, Dexcel Pharma announced that its independently developed new lung cancer targeted drug, Suvozole® (generic name: Suvotinib Tablets), has achieved the primary endpoint and positive topline results in the international multicenter Phase III clinical trial “Wukong 28” for first-line treatment of advanced non-small cell lung cancer with EGFR exon 20 insertion mutations.

Suvozole® becomes the world’s first and only oral targeted drug to achieve positive results in a global multicenter randomized controlled Phase III clinical trial for first-line treatment of EGFR exon20ins NSCLC.

“Wukong 28” is an international multicenter Phase III, open-label, randomized controlled clinical study conducted across 16 countries and regions worldwide, including China, the United States, and major European countries. It aims to evaluate the anti-tumor efficacy and safety of Suvozole® compared to platinum-based chemotherapy in previously untreated patients with advanced NSCLC carrying EGFR exon20ins. The primary endpoint is progression-free survival (PFS) assessed and confirmed by an independent blinded central review.

The topline results show that, compared to platinum doublet chemotherapy, Suvozole® demonstrated statistically and clinically significant improvement in PFS, meeting the primary endpoint. Specific data will be presented at upcoming international academic conferences.

Zhang Xiaolin, founder, chairman, and CEO of Dexcel Pharma, stated: “EGFR exon20 insertion mutations are a very challenging target. Several international pharmaceutical companies, including large multinational corporations, have attempted to tackle this target but have not succeeded. The achievement of the primary endpoint in ‘Wukong 28’ is a major milestone in the company’s ‘global innovation’ development journey. The success of this large-scale global registration clinical trial strongly validates the potential of Suvozole® as a first-line treatment for EGFR exon20ins NSCLC.”