DualityBio officially announced that DB-2304, the first-in-class BDCA2 ADC drug targeting autoimmune diseases, developed based on its proprietary DIMAC platform and holding global patents, has received Clinical Trial Notification (CTN) approval from Australia's Therapeutic Goods Administration (TGA) and completed the first global patient dosing.

 DB-2304 is an innovative ADC independently developed by DualityBio for the treatment of autoimmune diseases. Preclinical studies have demonstrated its exceptional immune-modulating effects and favorable safety profile. The drug utilizes a novel payload, showing broader and more potent inhibition of inflammatory factors compared to monoclonal antibodies targeting the same pathway. In disease animal models, DB-2304 exhibited superior efficacy to antibody-based therapies. 

Dr. Zhongyuan Zhu, CEO and Founder of DualityBio, stated: "The BDCA2 ADC leverages the synergistic effects of antibody and glucocorticoid immune modulation mechanisms, enabling highly effective immune regulation while reducing systemic exposure to hormones, thereby achieving better therapeutic outcomes and safety. DB-2304 is the seventh ADC innovative drug from DualityBio to enter clinical research, reflecting our mission to 'become a world-class ADC company and serve patients globally.'"