Abogen Biosciences Launches Global First Phase III Trial for mRNA-Based Shingles Vaccine ABO1108

Yesterday,Abogen Announces Initiation of Multicenter Clinical Trial for Its Self-Developed Lyophilized mRNA Vaccine Against Herpes Zoster (Project Code: ABO1108)IIIPhase clinical trial.

It is worth noting that this isThe world's first to enter Phase III clinical trialsHerpes Zoster mRNA Vaccine.

WithAdvancement of ABO1108 into Phase III clinical trials,ABO1108 is expected to leveragePhase III study data became the world’s first approved and marketedHerpes Zoster mRNA Vaccine.

Fastest Global Progress

ABO1108 is aLyophilized Varicella-Zoster Virus (VZV) Vaccine, Based onAbogen’s Protein Structure Design Platform utilizes proprietary combinations of mutation sites to design an optimized gE protein as an antigen.

ABO1108 also employsAbogen’s proprietary base modification technology and lipid nanoparticle (LNP) delivery system. Furthermore, the vaccine employs Abogen’s mature lyophilization formulation process, enabling stable storage for over two years at 2–8°C. This ensures excellent stability, convenient storage, and improved accessibility, holding promise to provide a safer and more effective vaccine solution for the prevention of varicella-zoster virus (VZV) infection.

ABO1108 has advanced rapidly in its clinical development, progressing from Phase I toStage III.

March 2025,ABO1108'sInvestigational New Drug (IND) ApplicationAcquisitionClinical implicit approval; in May of the same year, Abogen officially launched ABO1108'sPhase I Clinical Trial; Launched in November of the Same YearPhase II Clinical Trial.

On June 18, 2026, Abogen announced that,ABO1108 Initiates Multicenter Phase III Clinical Trial.

Positive Clinical Data

Actually,The rapid clinical advancement of ABO1108 is also based onPositive Results of ABO1108 in Phase I and II Clinical Trials

According to the Abogen Biosciences report,ABO1108 demonstrated a favorable safety profile in clinical studies andImmunogenicity:

Safety: Two-dose vaccination demonstrated favorable safety and tolerability across all age groups, with most adverse reactions being Grade 1 or Grade 2. No vaccine-related serious adverse events (SAEs), adverse events of special interest (AESIs), or adverse events leading to death or life-threatening conditions were reported. The safety profile was superior to that of the currently marketed recombinant zoster vaccine.

Immunogenicity:Vaccination with two doses induces comprehensive, high-level immune responses across all age groups. The pattern of immune response and the levels of key immunogenicity indicators are comparable to those of the marketed recombinant zoster vaccine, suggesting that ABO1108 has a solid immunological basis for high clinical protective efficacy.

It is precisely based onPositive Results from Phase I and Phase II Clinical Trials Support Abogen BiosciencesFurther DevelopmentABO1108'sPhase III clinical trial for protective efficacy, providing confirmatory data support for subsequent product marketing authorization applications.

Summary

According to public information, the competition in the research and development of mRNA vaccines for herpes zoster is currently very intense in China.

In addition to Abogen'sABO1108, along with multiple products from several other companiesThe mRNA vaccine for herpes zoster has been approved for clinical trials, including those fromSinovac,CSPC Pharmaceutical Group,Livanda Biologics, Anhui Zhifei Longcom Biologic,Yuekang Pharmaceutical、Magpie Biosciences,Afana Biosciences,Jiachen Xihai,Aimei Vaccine,Rongcan Biologics/ShanghaiInstitute of Biological Products,CSPC Pharmaceutical Group,Ruiji Biotech,Shenxin Biologics, etc.