Herpes zoster (HZ) is a viral skin disease caused by the reactivation of the latently infected varicella-zoster virus (VZV), characterized by vesicular eruptions accompanied with neuralgia. Some patients also suffer from postherpetic neuralgia (PHN) as a sequela. The live-attenuated shingles vaccine has shown low protective efficacy, while Shingrix, the recombinant protein vaccine with AS01, , has more than  95% protective efficacy but with high side effects. Lyophilized mRNA shingles vaccine  have potential with high protection efficacy with much lower safety concerns.

Rhegen Biotech utilizes proprietary technologies  covering cis-elements of and delivery vehicle for mRNA, which can efficiently  enhance mRNA stability and antigen specific immune responses. Lyophilization further improves vaccine stability and accessibility. Shingles vaccine developed by Rhegen Biotech is currently in clinical trials .

Compared to traditional technological routes, mRNA vaccines generally exhibit higher immunogenicity, particularly in stimulating cell-mediated immune responses, offering a new opportunity for developing novel preventive and therapeutic tuberculosis vaccines. Rhegen Biotech has developed the lyophilized  tuberculosis mRNA vaccine RH119, aimed to prevent primary Mycobacterium tuberculosis infection in healthy populations and to prevent active tuberculosis in latent TB infections. Using an optimized Mycobacterium tuberculosis antigen screening model, we rapidly evaluate the immunogenicity and protective efficacy of antigens covering the entire Mycobacterium tuberculosis lifecycle to determine the optimal combination of advantageous Mycobacterium tuberculosis antigens. RH119, based on a novel mRNA technology platform, employs Rhegen Biotech's unique immune enhancement technologies  as well as world-leading mRNA-LNP freeze-dried formulation technology, demonstrating high-level immune responses and protective effects in preclinical evaluations. The innate immunogenicity of mRNA favors vaccination, activating the immune system, such as inducing DC cell maturation upon mRNA activation of the TLR system, further generating robust B-cell and T-cell immune responses.

The combined mRNA vaccine for herpes zoster and tuberculosis is designed to provide simultaneous protection against both diseases—herpes zoster caused by the varicella-zoster virus and tuberculosis caused by Mycobacterium tuberculosis. With a single administration, the vaccine aims to elicit dual immune protection against two distinct pathogens, thereby improving immunization coverage in key populations and simplifying the vaccination schedule.

The vaccine utilizes Rhegen’s proprietary formulation platform, employing the spleen-targeting LNP system RhLNP-IE (T19) to co-encapsulate antigens from both pathogens within a single formulation. This approach is designed to induce robust cellular immunity against latent infections, ensuring synergistic efficacy between the two components. From a process standpoint, the use of a common carrier system streamlines manufacturing and reduces development costs.

Lower respiratory tract infections are among the most lethal infectious diseases globally and the fourth leading cause of death, with nearly 2.6 million deaths worldwide in 2019. Thus, respiratory infections have consistently posed significant global challenges. According to incomplete statistics, dozens of viruses can cause respiratory infections, including coronaviruses, influenza viruses, adenoviruses, respiratory syncytial viruses, and human metapneumoviruses. Reducing vaccination doses, improving vaccination efficiency, and lowering adverse reactions through combination vaccines have been one of the difficulties in vaccine development. The development of pan-respiratory vaccines mainly faces two challenges: 1) Antigen structural design, such as the prefusion conformation design for coronaviruses, respiratory syncytial viruses, and human metapneumoviruses; 2) Breakthroughs in co-encapsulation processes and quality control methods for multivalent vaccines. Our company's combination vaccine pipeline, based on mature foundational elements and technologies, systematically overcomes numerous technical challenges in pan-respiratory vaccine development from AI antigen design, immune-enhancing formulation prescriptions, freeze-drying processes, and process production and quality control, establishing a complete development and production process for combination vaccines. We initiate combination vaccine development using respiratory syncytial virus and human metapneumovirus vaccines as base vaccines.