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Press Releases
2025.10.07

Acepodia Announces IND Clearance by Japan PMDA for ACE1831 in the Treatment of IgG4-Related Disease; China IND Review in Progress

Acepodia Announces IND Clearance by Japan PMDA for ACE1831 in the Treatment of IgG4-Related Disease; China IND Review in Progress

ALAMEDA, Calif. & TAIPE, October 7, 2025 — Acepodia (6976: TT) today announced that the Investigational New Drug (IND) application for ACE1831 in the treatment of IgG4-related disease (IgG4-RD) has been cleared by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

In parallel, Acepodia has also submitted the IND application for ACE1831 to China’s National Medical Products Administration (NMPA), which is currently under review.

“Following the FDA clearance of ACE1831 for IgG4-related disease in the U.S. last November, the PMDA approval represents another key milestone in our global clinical development journey. As we expand into Asia with a stronger regional strategy, we continue to build on our team’s outstanding execution and collaboration. These milestones reinforce our confidence in ACE1831’s potential to bring transformative benefits to patients living with IgG4-related disease,” said Dr. Sonny Hsiao, Chairman and Chief Executive Officer of Acepodia.