SHANGHAI, China– Nov. 10, 2025 – Duality Biotherapeutics (“DualityBio”, HKEX:09606) partner Avenzo Therapeutics, Inc. (“Avenzo”), a clinical-stage biotechnology company developing next-generation oncology therapies, today announced the U.S. Food and Drug Administration (FDA) granted Fast Track designation to AVZO-1418/DB-1418, a potential best-in-class EGFR/HER3 bispecific antibody-drug conjugate (BsADC).

DualityBio and Avenzo entered into an exclusive license agreement, pursuant to which Avenzo will develop, manufacture and commercialize AVZO-1418/DB-1418, a potential best-in-class EGFR/HER3 bispecific ADC, globally (excluding Greater China) earlier this year.

The designation was granted for the treatment of patients with unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R mutation, whose disease has progressed on or after therapy with an EGFR tyrosine kinase inhibitor (TKI).

AVZO-1418/DB-1418 is currently being studied in a Phase 1/2 first-in-human, open-label clinical study designed to assess the safety, tolerability, and preliminary clinical activity of AVZO-1418/DB-1418 as a single agent and in combination therapy in patients with advanced solid tumors.

About DualityBio

Duality Biotherapeutics (HKEX:09606) is a clinical-stage biotech company dedicated to the discovery and development of next-generation ADCs to treat cancer and autoimmune diseases. DualityBio has successfully built several cutting-edge ADC technology platforms with global intellectual property rights. Leveraging a robust pipeline, DualityBio is conducting multiple global clinical trials across 20 countries and has enrolled over 2,700 patients for multiple clinical-stage ADC candidates.

Additionally, DualityBio has established strategic collaborations with global MNCs and leading biotech innovators. As a global ADC powerhouse, DualityBio is developing novel ADCs, including bispecific ADC candidates, novel-payload ADC candidates, and autoimmune ADC candidates. For more information, please visit www.dualitybiologics.com.

Media Contact: PR@dualitybiologics.com