Porton Congratulates Partner Acepodia on FDA and NMPA IND Approvals for ACE723, a Dual-Payload ADC

As the project's CDMO partner, Porton provided end-to-end process development and GMP manufacturing of clinical trial materials for ACE723.

Technical breakthroughs and seamless collaboration

· Throughout the project, the Porton team addressed multiple critical challenges in the development of the dual-payload ADC, establishing a robust and reproducible manufacturing process and successfully scaling the process to pilot scale.

· Through Porton's co-located development and manufacturing network, payload-linker process development and GMP manufacturing were aligned early with downstream conjugation requirements, allowing antibody production, payload-linker manufacturing, and ADC conjugation to be coordinated. The result was a fully coordinated workflow spanning process development, manufacturing, and subsequent project activities, translating into greater development efficiency and process robustness.

About ACE723

ACE723 is an investigational GPC3-targeted dual-payload ADC developed through Acepodia's proprietary AD2C platform, which integrates expertise in antibody engineering, medicinal chemistry and tumor biology. GPC3 is a tumor-associated antigen frequently expressed in HCC, providing a potential target for selective delivery of cytotoxic payloads to tumor cells.

HCC accounts for more than 70% of liver cancer cases worldwide. Liver cancer is one of the most common and lethal cancers globally, with a five-year survival rate of only about 22%. Although immunotherapy-based combination regimens have improved first-line treatment for patients with unresectable or metastatic disease, significant unmet medical needs remain, particularly for patients whose disease progresses or becomes resistant to treatment. This highlights the need for therapies with differentiated mechanisms of action and novel approaches to address the limitations of current treatment options. The incidence of HCC is particularly high in Asia, and as the global number of liver cancer patients continues to rise, the development of innovative therapies with entirely new mechanisms of action has become an urgent medical need, with significant potential for both clinical application and market growth.

The planned Phase 1 study will evaluate the safety, tolerability, dose-limiting toxicities, pharmacokinetics and preliminary anti-tumor activity of ACE723 in patients with unresectable or metastatic HCC. The dose-escalation portion of the study is expected to characterize the safety profile and establish a recommended dose for subsequent clinical development and potential expansion cohorts.

ACE723 remains in clinical development, and its safety and efficacy have yet to be established in clinical trials. The candidate has not been approved for marketing.

Source for clinical and efficacy descriptions: Acepodia

About Acepodia

Acepodia (6976: TT) is a clinical-stage biotechnology company developing next-generation therapies for cancer and autoimmune diseases through its proprietary conjugation technology platforms. Leveraging a family of bio-orthogonal click chemistry approaches originating from Nobel Prize laureate Carolyn Bertozzi’s laboratory, Acepodia has built a modular platform designed to combine antibodies with immune cells or therapeutic payloads to create differentiated treatment modalities.

The Company is advancing a pipeline based on its Antibody-Cell Conjugation (ACC) and Antibody-Dual-Drugs Conjugation (AD2C) platforms. These technologies are designed to enable flexible integration across antibodies, immune cells, and payload architectures, with the goal of enhancing targeted therapeutic activity while supporting broad applicability across hematologic malignancies, solid tumors, and autoimmune diseases.

By applying its conjugation technologies across multiple therapeutic modalities, Acepodia aims to develop scalable and differentiated therapies for patients with significant unmet medical needs.

About the Porton Biologics and Conjugates CDMO Platform

The Porton Biologics and Conjugates CDMO Platform specializes in custom development services for novel conjugate drugs, including antibody-drug conjugates (ADCs), AOCs, DACs, PDCs and RDCs. With R&D centers and manufacturing facilities located in close proximity, the platform enables efficient logistics and coordinated operations, providing one-stop CMC solutions for global pharmaceutical companies and drug R&D organizations. Its services span developability assessment, conjugation technology development, process and formulation development, scale-up and manufacturing, analytical and quality research, IND filing, clinical drug manufacturing and beyond — meeting clients' CMC needs at every stage of their programs, with the mission of enabling earlier access to good medicines.