Abogen today announced the initiation of a Phase III clinical trial for its proprietary lyophilized mRNA shingles vaccine (ABO1108), making it the world's first mRNA shingles vaccine to enter Phase III clinical development. This milestone accelerates the commercialization of Abogen's mRNA platform and highlights China's growing contribution to. global innovative drug development.

The Phase III trial is designed as a multi-center, randomized, double-blind, and placebo-controlled study, co-conducted by the provincial CDCs across Guangxi, Zhejiang, Hebei, and Shandong provinces. The study aims to comprehensively evaluate the protective efficacy, safety, and immunogenicity of ABO1108.

Promising Phase I/II Data Demonstrate Exceptional Profile

ABO1108 received Investigational New Drug (IND) clearance in March 2025, with Phase I and Phase II clinical trials initiated in May and November of the same year, respectively. Key results show:

Safety: A two-dose regimen demonstrated a favorable safety and tolerability profile across all age groups. Adverse events (AEs) were predominantly Grade 1 or 2. No vaccine-related serious adverse events (SAEs), adverse events of special interest (AESIs), or life-threatening / fatal events were reported, demonstrating a safety profile superior to the currently marketed recombinant shingles vaccine.

Immunogenicity: The two-dose regimen induced robust, comprehensive immune responses across all age groups. The immune response patterns and core immunogenicity metrics were comparable to those of the marketed recombinant shingles vaccine, suggesting potential for high clinical efficacy

The positive Phase I / II results fully support the advancement into the Phase III efficacy trial, which aims to provide definitive confirmatory data for subsequent regulatory approval.

Cutting-Edge Innovation Drives Technical Breakthroughs

ABO1108 utilizes Abogen's proprietary base-modification technology and lipid nanoparticle (LNP) delivery system. The ionizable cationic lipid — the core component of this LNP platform —already had its safety and delivery efficiency proven in global, large-scale Phase III clinical trials, and has been granted patents in major jurisdictions including China, the United States, Australia, and Europe.

Moreover, ABO1108 leverages Abogen's mature lyophilization formulation technology, allowing it to remain stable at 2–8°C for up to three years. This ensures excellent product stability, storage and transportation convenience, and broad accessibility.

Vast Market Potential and Strong Growth Prospects

Data from the U.S. Centers for Disease Control and Prevention (CDC) showed that shingles vaccine penetration among adults aged 50 and older reached 36.0% in 2022. By contrast, public data indicates that as of June 2023, the vaccination rate for the same demographic in China was only 1.2%. Compared to mature overseas markets, the significant gap in domestic uptake highlights immense headroom for increasing market penetration and a robust runway for long-term growth.