Acepodia Announces NMPA Approval of ACE1831 for IgG4-RD Phase Ib/IIa Clinical Trial,Marking a Major Step Forward in Its Global Multi-Country Development Strategy

Acepodia Announces NMPA Approval of ACE1831 for IgG4-RD Phase Ib/IIa Clinical Trial,Marking a Major Step Forward in Its Global Multi-Country Development Strategy

Acepodia Inc. (6976.TT) today announced that its lead allogeneic cell therapy candidate ACE1831 has officially received approval from China’s National Medical Products Administration (NMPA) to initiate a Phase Ib/IIa clinical trial for IgG4-related disease (IgG4-RD). This approval marks an important milestone in ACE1831’s global clinical development and further supports the company’s multi-center clinical strategy across the United States, Japan, and China.

The upcoming global trial plans to enroll approximately 30 patients across the U.S., Japan, and China, with the following key objectives:
- Primary Objective: Evaluate safety and tolerability
- Secondary Objectives: Assess efficacy and cell persistence

According to the NMPA approval notice, Acepodia must first complete the first-in-human (FIH) Phase I study of ACE1831 and finalize data analysis to determine the appropriate dosage before officially initiating the IgG4-RD Phase Ib/IIa trial. The authority also emphasized the need to strengthen risk management related to cell therapy, including long-term follow-up, dosing interval justification, and enhanced viral safety controls.

IgG4-RD is a rare, chronic, fibroinflammatory systemic autoimmune disease. Between 2015 and 2019, its incidence in the United States increased at a 15% compound annual growth rate, with an estimated 17,700 patients in the U.S. and 7,800 patients in Japan by 2023. Current standard-of-care treatments include glucocorticoids and B-cell-depleting agents; however, more than 50% of patients experience relapse, highlighting a significant unmet medical need.

ACE1831 is developed using Acepodia’s proprietary Antibody-Cell Conjugation (ACC) technology and is an allogeneic γδ2 T-cell therapy engineered to selectively target CD20-expressing B cells. Preclinical studies have demonstrated potent and selective B-cell killing, supporting its potential therapeutic role in IgG4-RD.

The global ACE1831-201 study is expected to complete patient enrollment by 2027, with timelines adjusted according to site activation and recruitment progress. “ The global advancement of ACE1831 will enhance the company’s platform value and accelerate its clinical and regulatory pathway”, said Dr. Sonny Hsiao, Chairman and Chief Executive Officer of Acepodia.