Shanghai, China, September 24, 2025 — DualityBio (or the "Company", Stock Code: 9606.HK) today announced that the first patient has been dosed in Australia in the Phase 1a/1b global clinical study of its internally discovered and developed ADAM9-targeting antibody-drug conjugate (ADC) DB-1317. Furthermore, the U.S. Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) clearance for DB-1317.

This global study (NCT07141706) will be conducted simultaneously across Australia, the United States, and China. It aims to evaluate the safety, tolerability, and preliminary efficacy of DB-1317 as a monotherapy in patients with advanced solid tumors.

DB-1317 is a next-generation ADC developed based on DualityBio's proprietary ADC platform, DITAC, and is wholly owned by the Company globally. It carries a topoisomerase I inhibitor payload. The target, ADAM9, is highly expressed in various gastrointestinal cancers, such as gastric, colorectal, and pancreatic cancers, while showing low expression in normal tissues. Preclinical data have demonstrated that DB-1317 exhibits significant and potent anti-tumor activity in multiple gastrointestinal cancer models, indicating broad clinical translational potential.

Dr. John Zhu, Founder and CEO of DualityBio, commented, "DB-1317 is at the forefront of global innovation among ADAM9-targeting ADCs. We remain committed to our ADC=CP² global clinical strategy and plan to accelerate the global Phase I clinical development of DB-1317 in the second half of 2025. We will continue to explore its potential across a wider range of tumor types, aiming to bring this innovative therapeutic option to patients worldwide as soon as possible."

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 17 countries and has enrolled over 2,600 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. 

Media Contact: PR@dualitybiologics.com

Investor Contact: IR@dualitybiologics.com