Chinese biotechnology company DualityBio (HKEX:9606) announced on Monday that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its next-generation HER3-targeting antibody-drug conjugate (ADC) DB-1310.

This designation is for the treatment of adult patients with advanced, unresectable or metastatic nonsquamous non-small cell lung cancer (nsqNSCLC) with an EGFR exon 19 deletion or L858R mutation with disease progression on or after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.

DB-1310 is a novel ADC targeting HER3 developed using DualityBio's proprietary DITAC platform. First-in-human Phase I/IIa clinical trial data of DB-1310 demonstrated encouraging efficacy and a manageable safety profile in patients with advanced solid tumours who had failed standard therapies.