DualityBio DB-1324 HREC approval obtained and received TGA acknowledgment of the eCTN

Shanghai, China, October 13, 2025 — DualityBio (HKEX: 9606.HK) today announced that its DB-1324 project has received clinical trial approval for solid tumors from the Human Research Ethics Committee (HREC) and also received the Therapeutic Goods Administration (TGA) in Australia. The company is set to commence its Phase I clinical trial shortly.

DB-1324 was developed based on DualityBio’s proprietary Duality Immune Toxin Antibody Conjugates (DITAC) platform. In 2024, DualityBio entered into an exclusive licensing agreement with the global biopharma company, GSK plc (LSE/NYSE:GSK). Under the terms of the agreement, DualityBio grants GSK an exclusive option to obtain a license to develop and commercialize DB-1324 worldwide (excluding mainland China, Hong Kong, and Macau). DB-1324 has the potential to unlock multiple combination therapy opportunities to strategically complement GSK's oncology portfolio.

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 2,600 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.

For more information, please visit www.dualitybiologics.com

Media Contact: PR@dualitybiologics.com

Investor Contact: IR@dualitybiologics.com