Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of sunvozertinib for the treatment of  locally advanced or metastatic non-small cell lung cancer (NSCLC) patients 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.

Previously, sunvozertinib received accelerated approval in China, making it the world's first and only oral drug for NSCLC patients with EGFR exon20ins. It has also been granted Breakthrough Therapy Designations (BTDs) by both the U.S. FDA and the China Center for Drug Evaluation (CDE) for treating EGFR exon20ins NSCLC.

The submission is supported by results from the WU-KONG1 Part B study, a multinational pivotal study investigating the efficacy and safety of sunvozertinib in relapsed or refractory EGFR exon20ins NSCLC patients from Asia, Europe, North America, and South America. Sunvozertinib met the primary endpoint by demonstrating statistically significant and clinically meaningful objective response rate (ORR), as assessed by an independent review committee (IRC), while maintaining a manageable safety profile. Data from the study were presented in an oral session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

"We are encouraged by the potential of sunvozertinib as a single oral agent to improve outcomes for patients with EGFR exon20ins NSCLC." said Xiaolin Zhang, PhD, CEO of Dizal. "The filing for approval of sunvozertinib marks Dizal's first NDA submission to the FDA, which represents an important step forward as we continue our efforts to address unmet medical needs globally. We look forward to working closely with the FDA on their review of our application."

Lung cancer is the leading cause of cancer incidence and mortality worldwide. NSCLC accounts for approximately 80%-85% of all lung cancers. Patients with NSCLC harboring EGFR exon20ins are reported to have poorer prognosis than those with other EGFR sensitizing mutations.  Sunvozertinib, with its innovatively designed molecular structure, provides enhanced efficacy, safety, and ease of administration.

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