DUALITYBIO-B (09606) surged over 3% in early trading, reaching HK$318 with a turnover of HK$23.3955 million. The company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its next-generation HER3-targeting antibody-drug conjugate, DB-1310.

The FTD is for treating adult patients with advanced/unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer (IHC 0, 1+, or 2+/ISH-negative) who have previously received endocrine therapy, CDK4/6 inhibitors, and may or may not have undergone chemotherapy in the unresectable or metastatic setting, or experienced disease recurrence within six months of completing adjuvant chemotherapy.

DB-1310 is the first HER3-ADC drug globally to receive FTD for this indication. The broad FTD scope covers both chemotherapy-naïve and chemotherapy-resistant scenarios in HR+/HER2- breast cancer, which is expected to accelerate its clinical development in frontline and later-line treatment settings.