SHANGHAI, China, August 25, 2026 – Duality Biotherapeutics, Inc. (“DualityBio” , HKEX: 09606, or "the Company") today announced that DB-1317, a Company-developed antibody-drug conjugate (“ADC”) targeting ADAM9, has been granted Fast Track Designation ("FTD") by the U.S. Food and Drug Administration ("FDA") for the treatment of advanced/unresectable or metastatic pancreatic ductal adenocarcinoma ("PDAC").

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and that have the potential to address unmet medical needs. PDAC is the most common histologic subtype of pancreatic cancer and is characterized by challenges in early diagnosis, rapid disease progression and poor prognosis. Many patients already have unresectable or metastatic disease at the time of diagnosis. Despite advances in systemic treatment options in recent years, achieving long-term survival remains a significant challenge for patients with advanced unresectable or metastatic PDAC, underscoring the urgent need for new and effective treatment options.¹ Following the FTD, the Company intends to engage more closely with the FDA regarding the clinical development of DB-1317 and actively advance its global clinical development.

About DB-1317

DB-1317 is a next-generation ADC developed using the Company’s proprietary DITAC platform, for which the company holds global rights. Its target, ADAM9, is highly expressed across multiple tumor types, including gastric cancer, colorectal cancer, pancreatic cancer and non-small cell lung cancer, while exhibiting relatively low expression in normal tissues. Preclinical studies have demonstrated significant antitumor activity of DB-1317 across multiple tumor models. DB-1317 is currently being evaluated in a global Phase 1a/1b clinical trial in patients with advanced solid tumors (NCT07141706).

About DualityBio

DualityBio is a clinical-stage innovative biopharmaceutical company dedicated to developing next-generation antibody-drug conjugates for patients with cancer and autoimmune diseases. The Company has successfully built multiple next-generation ADC technology platforms with global intellectual property rights. Grounded in a deep understanding of disease biology, DualityBio has established a robust clinical-stage ADC pipeline and is conducting multiple global, multicenter clinical trials across nearly 20 countries, with over 3,500 patients enrolled to date. Furthermore, DualityBio has entered into several out-licensing collaborations with global pharmaceutical companies and leading innovative biotech firms. Serving as a global engine for ADC innovation, DualityBio continues to develop next-generation novel ADCs, including bispecific ADCs, ADCs with novel payloads, and autoimmune ADCs.    

For more information, please visit www.dualitybiologics.com.

Media Contact: PR@dualitybiologics.com

Investor Contact: IR@dualitybiologics.com

Reference

1 National Cancer Institute. Pancreatic Cancer Treatment (PDQ®)–Health Professional Version. Updated February 12, 2025.