DUALITYBIO-B (09606) saw an early trading increase of nearly 3%, reaching 2.23% at the time of writing, with shares trading at HK$301 and a turnover of HK$18.0969 million.

The rise follows an announcement by the company's partner, Avenzo Therapeutics, Inc., that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its potential best-in-class EGFR/HER3 bispecific antibody-drug conjugate (ADC), AVZO-1418/DB-1418.

Avenzo, a U.S.-based clinical-stage biotech company focused on developing next-generation oncology therapies, entered into an exclusive licensing agreement with DUALITYBIO earlier this year. Under the agreement, Avenzo is responsible for the global development, manufacturing, and commercialization of AVZO-1418/DB-1418, excluding Greater China.

The Fast Track designation applies to the treatment of unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR exon 19 deletions or exon 21 L858R mutations who have experienced disease progression after EGFR tyrosine kinase inhibitor (TKI) therapy.

Currently, AVZO-1418/DB-1418 is undergoing an open-label, first-in-human Phase 1/2 clinical trial. The study aims to evaluate the safety, tolerability, and preliminary clinical activity of AVZO-1418/DB-1418 as both a monotherapy and in combination therapies for patients with advanced solid tumors.