Acepodia's Off-the-Shelf γδ2 T Cell Therapy ACE1831 Receives NMPA Approval for IgG4-RD Clinical Trials in China, Powered by Nobel Prize-Winning Bioorthogonal Chemistry

Dec 04, 2025 13:24 CST Updated 13:24

Acepodia

Developer of Cell Therapies for Cancer Treatment

December 3, 2025China's NMPA Gives Green Light to Acepodia’s Breakthrough Cell Therapy! ACE1831, an "off-the-shelf" allogeneic γδ2 T cell therapy developed on the revolutionary Antibody-Cell Conjugation (ACC) platform, has been officially approved for Phase Ib/IIa clinical trials in China targeting refractory autoimmune disease—IgG4-related disease (IgG4-RD). This not only marks a significant step in the global development of the therapy but also highlights Acepodia’s strategic determination to advance multicenter clinical trials simultaneously in China, the U.S., and Japan.

This multinational research program plans to recruit approximately 30 patients, with the primary goal of confirming the safety and tolerability of ACE1831 in humans, while also preliminarily exploring its efficacy and cell persistence in IgG4-RD. To ensure patient safety and trial quality, the NMPA requires Acepodia to first complete the Phase I dose-finding study of ACE1831 in humans. After determining the optimal therapeutic dose based on this study, the Phase Ib/IIa trial can be initiated. Meanwhile, regulatory authorities have emphasized the need to strengthen risk management, including long-term follow-up plans, rigorous justification of dosing regimens, and stricter viral safety controls.

Why is ACE1831 Worth Paying Attention To?

Targeting "Criminal" Cells: Leveraging its proprietary ACC technology, ACE1831 is designed to precisely eliminate CD20-expressing B cells (a key driver of IgG4-RD), demonstrating robust selective clearance capacity in preclinical studies.

Nobel Prize-Level Technology Foundation: The core of the ACC platform is "bioorthogonal click chemistry," which won the 2022 Nobel Prize in Chemistry (pioneered by Dr. Carolyn Bertozzi). It acts like "molecular Velcro," seamlessly and efficiently "clicking" targeting antibodies onto the surface of living cells (such as γδ2 T cells) to create a novel ACE (Antibody Cell Effector) therapy.

Breakthrough Traditional Limitations:

Safer: Avoids common severe side effects of CAR-T (CRS, neurotoxicity).

Easy to produce: "Plug and play" design significantly simplifies the process, with enormous scalability potential.

Strong Infiltration: A unique mechanism may activate multiple signaling pathways, enhancing the ability of immune cells to recognize and penetrate deep into lesions (crucial for solid tissue diseases/solid tumors).

Broad Indications: Modular platform provides a powerful tool for expanding from cancer to autoimmune diseases like IgG4-RD.

Shanghai Bailing Bio proposed "Innovative Processes Accelerate Drug Accessibility"Ideas, establish matureCAR-DNT/γδ T Culture, transduction and other platform technologies, while also having a completeCAR-DNT/γδ TProduction Quality Control Standards, Multiple DeliverablesCAR-DNTProject, with successful project experience, helps customers solve CMC challenges.

Company Profile:

Biosmelt Pharma, established in 2021 and located in the Wisdom Plaza of Pujiang Lingang International Technology City in Minhang District, Shanghai, is a technology service enterprise specializing in CDO/CMO services for ATMP novel drugs.

Bailian Pharma's Shanghai CMC R&D Center covers an area of 3,000 square meters and meets cGMP and BSL-2 laboratory requirements for pathogenic microorganisms. It has established multiple Class A production lines that comply with the requirements for IIT clinical research, IND applications, and Phase I clinical trials.Capable of providing full-process services from cell technology R&D, delivery vector development (including tissue targeting), CMC process development, formulation development (including lyophilization), quality research to GMP production, having successfully delivered dozens of batches of clinical therapeutic drug production to customers.

Main Business:

Core businesses include the development of novel delivery carriers (DD), novel cell technology development (CD), process development (PD), analytical method development (AD), formulation development (FD), quality system development (QD), GMP-level small-scale trial, pilot production, and commercial production services.The company also provides services such as registration applications in China, the US, and Europe, clinical research consulting, and business development for its clients.

Service Product Type:

Universal Cell Drug(Immune cells - CAR-T, CAR-NK, CAR-Macrophage, CAR-Treg, CAR-DNT/γδ T, TIL, TCR-T, DC; Stem cells - MSC, iPSC and derived cells, genetically modified CD34+ HSC, etc.);

Gene Delivery Drugs(LV, AAV, engineered exosomes, engineered VLP, oncolytic poxvirus, targeted LNP/mRNA, etc.).

Bailian Pharmaceutical withInnovative Processes Accelerate Drug AccessibilityFor the mission, fully empower start-up enterprises, and promote the proof of concept and commercial transformation of innovative technologies.

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