Acepodia Announces TFDA IND Approval for ACE723, Advancing Clinical Development in the United States, China and Taiwan

Acepodia (6976: TT) today announced that the Taiwan Food and Drug Administration (TFDA) has approved the Company’s Investigational New Drug (IND) application for ACE723. ACE723 is a GPC3-targeted dual-payload antibody-drug conjugate developed using Acepodia’s proprietary Antibody-Dual-Drugs Conjugation (AD2C) platform. It is the first candidate from the platform to enter clinical development and is being developed for the treatment of unresectable or metastatic hepatocellular carcinoma (HCC).

Following IND clearances from the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) in September 2026, the TFDA approval further expands ACE723’s clinical development footprint and provides a regulatory foundation for clinical studies in the United States, China and Taiwan.

Acepodia will continue to advance Phase 1 clinical development of ACE723 to evaluate its safety, tolerability, pharmacokinetics and preliminary antitumor activity. Clinical data generated from these studies will inform subsequent development decisions for ACE723 and contribute to the evaluation of the AD2C platform’s therapeutic potential.