People's Financial News｜Dizal Pharma: Dizal's Self-Developed ZEGFROVY® (Sunvozertinib) Receives U.S. FDA Accelerated Approval for Market Launch

People's Financial News dated July 3 - According to a notice released by Dizal Pharma (SSE: 688192) on the morning of July 3, Dizal's self-developed sunvozertinib (brand name: ZEGFROVY®, generic name: Sunvozertinib Tablets) has officially received approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA). It is approved for the 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), as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. ZEGFROVY® was approved through the FDA's Priority Review process and is now the world's first and only domestic innovative drug for treatment of EGFR Exon20ins NSCLC approved in the U.S. It presents a significant innovation at the molecular design level, overcoming difficult-to-target mutations, and it is the first global innovative drug independently developed in China to receive approval in the U.S. market.