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Infectious Diseases
  • Preclinical Research
  • IND Application
  • Phase I
  • Phase II
  • Phase III
  • RH110 Lyophilized VZV mRNA vaccine

    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 .

  • RH119 Lyophilized TB mRNA vaccine

    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.

  • RH225 Lyophilized combined mRNA vaccine for respiratory infection(RSV+hMPV)

    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.

Oncology Therapeutics
  • Preclinical Research
  • IND Application
  • Phase I
  • Phase II
  • Phase III
  • RH115 Personalized Cancer mRNA vaccine (PCV)

    Over the past decade, immune-based therapies, represented by immune checkpoint inhibitors (ICIs), have provided cancer patients with better clinical benefits, featuring higher specificity, fewer side effects, and better long-term outcomes compared to traditional cancer treatments (such as surgery, radiotherapy, and chemotherapy). Personalized tumor vaccines based on active immunity offer advantages such as high personalization, induction of long-term immune memory to prevent recurrence, safety typically limited to injection site reactions, and broad adaptability to multiple tumor types. The combined use of personalized tumor vaccines and immune checkpoint inhibitors will usher in a new era of cancer immunotherapy. Rhegen Biotech employs its proprietary RhCosmos AI platform for tumor neoantigen prediction and utilizes unique immune enhancement technologies (antigen design, immune-enhancing cap structure analogs, and LNP delivery systems) to produce personalized tumor mRNA vaccines, effectively inducing tumor neoantigen-specific cellular immune responses.

Autoimmune disease
  • Preclinical Research
  • IND Application
  • Phase I
  • Phase II
  • Phase III
  • RH20A In vivo CAR-T therapy for lupus nephritis

             Epidemiological surveys show that there are approximately 3 to 4 million patients with systemic lupus erythematosus (SLE) worldwide, with a prevalence of 40–200 per 100,000 people and an annual incidence of 1–10 per 100,000 people. Females account for up to 90% of cases. Among global SLE patients, 30% to 70% develop renal involvement during the disease course, a condition known as lupus nephritis (LN).Conventional therapy with glucocorticoids combined with cyclophosphamide remains the first-line regimen for LN. However, long-term use of steroids and immunosuppressants often leads to toxic side effects such as infections, myelosuppression, and secondary malignancies.B cells play a central role in the pathogenesis of LN, and immune resetting is expected to become a third strategic approach, following broad-spectrum immunosuppressants and targeted antibodies.With its technical features of higher safety, stronger controllability, and greater depth of immune cell depletion, mRNA-CAR-T is poised to be a new-generation immune resetting tool, distinct from traditional CAR-T, antibody drugs, and small-molecule therapies. mRNA-based in vivo CAR-T achieves transient expression in vivo, which not only avoids the risk of gene insertion associated with viral vector integration but also enables more controllable expression kinetics, allowing flexible regulation of CAR activity through repeated dosing.RegiBio's T cell-targeted delivery technology enables the development of an off-the-shelf in vivo CAR-T therapy for LN that does not require lymphodepletion.


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