Shandong University Seeks to Transfer a Novel Therapeutic and Preventive Hepatitis B mRNA Vaccine for RMB 200,000
Recently, Shandong University released a public notice on the transformation of scientific and technological achievements, proposing to transfer“A vaccine for the treatment or prevention of hepatitis B virus”Transfer of relevant patents, with a minimum transfer price ofRMB 200,000. The inventors of this patent areZhao Huajun and His Team。
Image from the Shandong Provincial Technology Property Rights Trading Platform
This technology isA Hepatitis B Virus mRNA Vaccine Technology, belongs toBiopharmaceutical Sector, the core isDevelopment of an mRNA Vaccine for Both Treatment and Prevention of Hepatitis B Virus Infection, address the technical pain points of existing hepatitis B vaccines, achieve a functional cure for hepatitis B, and enhance the immune response to hepatitis B vaccination in adults.
Hepatitis B Virus InfectionAs a global public health challenge, chronic hepatitis B is prone to causing severe complications such as liver cirrhosis and hepatocellular carcinoma. However, the technical limitations and immunological shortcomings of existing prevention and treatment strategies have become core obstacles to achieving functional cure and effective population-wide prevention of hepatitis B. In current clinical practice, the development of therapeutic hepatitis B vaccines has encountered setbacks, while prophylactic hepatitis B vaccines exhibit low efficacy in inducing immune responses in adults. Coupled with inherent issues in traditional vaccine production and immune mechanisms, these factors create significant market pain points within the hepatitis B prevention and control system, failing to meet the core clinical demands for precise treatment and long-term prevention of hepatitis B.
From a therapeutic perspective, the research and development and application of existing therapeutic vaccines for chronic hepatitis B face critical technical bottlenecks.
On one hand, therapeutic hepatitis B vaccines under development, such as recombinant protein vaccines, DNA vaccines, and dendritic cell (DC) vaccines, due toLack of Ideal Adjuvants and Antigen Delivery Systems, making it difficult to effectively break the immune tolerance state in patients with chronic hepatitis B, inadequately induce specific immune responses of CD4+ T cells and CD8+ T cells, and clear hepatitis B virus antigens from the body. Consequently, achieving functional cure for hepatitis B, which is urgently needed in clinical practice, remains elusive. Most patients require long-term medication to control the disease, resulting in high treatment costs and limited prognostic outcomes.
On the other hand, although traditional nucleic acid vaccines can achieve antigen expression,Some technologies carry a risk of intranuclear infection., andLow Antigen Delivery Efficiency, mRNA is susceptible to degradation by extracellular RNases, exhibits insufficient uptake by target cells, and fails to effectively elicit humoral and cellular immune responses. Consequently, no mature therapeutic mRNA vaccines for hepatitis B have been applied in clinical practice, leaving a significant technological gap in the field of chronic hepatitis B treatment.
From a preventive perspective, traditional prophylactic hepatitis B vaccines exhibit significant limitations in population-specific immunogenicity.
Commercially available traditional hepatitis B vaccines, such as recombinant Hepatitis B Vaccine (rHBVvac), exhibit extremely low immunogenicity in older populations (adults). They fail to effectively induce the production of high levels of protective anti-HBs antibodies, representing a core challenge in adult hepatitis B prevention. Furthermore, the antigens in traditional vaccines are mostly heterologously expressed, resulting in insufficient fidelity of protein spatial structure and post-translational modifications (such as glycosylation). This leads to limited immune response intensity; some vaccinees fail to generate effective antibodies, significantly compromising vaccine efficacy and hindering effective protection across the entire population.
Furthermore,Traditional Hepatitis B Vaccines Still Have Inherent Defects in Production and Immune Mechanisms, further limiting its clinical application.
Production Side, traditional protein vaccines rely on cell expansion for production, requiring complex processes of cell culture, antigen extraction, and purification. This results in long production cycles, high costs, and significant challenges in monitoring and quality control during manufacturing, often leading to issues such as insufficient antigen expression and substandard purity;Immune Side, traditional vaccines lack intrinsic adjuvant effects and require the addition of exogenous adjuvants to enhance immunogenicity, resulting in complex manufacturing processes. Furthermore, certain live-attenuated vaccines carry potential risks of causing disease, such as inducing herpes zoster, thereby compromising their clinical safety profile.
These issues directly limit the clinical efficacy and accessibility of hepatitis B prevention and treatment:Therapeutic vaccines fail to achieve functional cures, leading to disease relapse in patients with chronic hepatitis B; preventive vaccines are ineffective in inducing immunity in adults, leaving gaps in universal prevention systems. Inherent defects in production and immunogenicity drive up costs and compromise safety, making it difficult to meet the demands of large-scale hepatitis B prevention and control. To address these clinical pain points, there is an urgent need for a novel vaccine that combines both therapeutic and preventive functions, is suitable for the entire population, and features efficient and safe production processes, thereby overcoming the core technical bottlenecks in hepatitis B prevention and control.
This hepatitis B virus mRNA vaccine relies onIntegrated Design for Treatment and Prevention, Optimized and Modified mRNA with Lipid Nanoparticle DeliveryCore innovations comprehensively overcome the therapeutic, immunological, and manufacturing limitations of traditional hepatitis B vaccines, delivering significant advantages in immunogenicity, clinical adaptability, production efficiency, and safety profile, thereby providing an efficient solution for the functional cure of hepatitis B and effective prevention across the entire population.
From the Perspective of Core Molecular Design, codon optimization and multi-dimensional modifications enable efficient antigen expression and potent immune activation.Codon optimization of the full-length hepatitis B surface antigen (HBsAg) gene using CAI and MFE algorithms to enhance protein expression and mRNA stability; modification of the SEQ ID NO. 2 sequence through untranslated region engineering and pseudouridine substitution to ensure high-fidelity antigen expression in the cytoplasm with native spatial conformation and glycosylation, thereby significantly boosting immunogenicity. Furthermore, the mRNA activates intracellular pathogen-associated pattern recognition receptors, providing an inherent adjuvant effect that eliminates the need for additional adjuvants, simplifies the manufacturing process, and removes the potential disease risks associated with live-attenuated vaccines.
From the Perspective of Delivery System Construction, customized liposomal nanoparticles achieve efficient mRNA delivery and stable protection.Liposomes are formulated using ionizable cationic lipids to precisely protect mRNA from RNase degradation, thereby facilitating target cell uptake and intracellular release. The particle size of the lipid-mRNA complex is optimized to 80–120 nm to balance delivery efficiency and stability. Administered via intramuscular injection, the vaccine offers ease of use and strong clinical adaptability.
From the Perspective of Production and Clinical Function, the in vitro transcription process integrates prevention and treatment while balancing cost control with applicability across all scenarios.Production leverages in vitro transcription, eliminating the need for cell expansion and bypassing the traditional vaccine steps of culture, extraction, and purification. This approach offers ease of quality control, short production cycles, low costs, and high batch-to-batch stability. Clinically, it achieves dual therapeutic and prophylactic efficacy: it breaks immune tolerance in patients with chronic hepatitis B, reverses CD8+ T cell exhaustion, clears HBV antigens, thereby achieving functional cure and inducing long-term immune memory; meanwhile, it elicits robust immune responses in older age groups (simulating adults), overcoming the lack of immunogenicity of traditional vaccines in adults and enabling protection across the entire population.
Furthermore, the vaccine can be combined with immunomodulatory agents such as PD-1 monoclonal antibodies and interleukin (IL) cytokines to further enhance immune efficacy, thereby meeting the needs of complex clinical cases and expanding its therapeutic applications.
These advantages facilitate a comprehensive upgrade across the entire chain of hepatitis B prevention and control:Highly efficient molecular design and delivery systems significantly enhance vaccine immunogenicity. The integrated prevention-and-treatment design breaks through the barriers of traditional approaches, achieving a leap from disease control to functional cure, and from pediatric prevention to population-wide protection. The in vitro transcription process facilitates large-scale production and widespread adoption of vaccines. The natural adjuvant effect, combined with the absence of risk for nuclear infection, balances immunogenicity and safety. This technology overcomes multiple bottlenecks of conventional hepatitis B vaccines, achieving quadruple improvements in immunogenicity, clinical adaptability, production efficiency, and safety profile. It provides robust technical support for clinical practice in hepatitis B prevention and treatment, demonstrating high value for clinical translation and market application.
R&D momentum in the hepatitis B prevention and treatment sector, encompassing both vaccines and innovative therapies, is on the rise. Domestic and international companies are focusing their strategic layouts on diverse technological pathways, including mRNA technology, epigenetic regulation, lentiviral vectors, and siRNA combined with monoclonal antibodies, among whichmRNA-based Hepatitis B Vaccines: Dual Potential for Therapy and PreventionHave become core R&D directions, with multiple products entering clinical stages. Traditional recombinant protein vaccines remain the mainstream products in the current market. Products based on various technological routes exhibit significant differentiation in terms of clinical development stage, focused indications, and mechanisms of action.
Chengdu Weijin Biopharmaceutical Technology Co., Ltd.R&DWGc-0201 InjectionUtilizing a proprietary mRNA sequence design and a highly efficient targeted LNP delivery system, it can activate dual immune responses against HBV and associated tumors, break immune tolerance in virus-driven tumors, and combine antiviral and antitumor mechanisms. It can be used as a monotherapy or in combination with antiviral drugs and immune checkpoint inhibitors, demonstrating the potential to achieve functional cure for hepatitis B. As the world’s first mRNA therapeutic vaccine targeting hepatitis B virus-related diseases, it received Investigational New Drug (IND) approval from the U.S. FDA in October 2025, having previously completed investigator-initiated trials (IIT) in China that verified its favorable safety profile and immunogenicity.
Genetically Engineered Recombinant Protein VaccineIt is currently the only mainstream type of hepatitis B vaccine on the market, replacing the discontinued plasma-derived inactivated vaccine. Produced by expressing and purifying the hepatitis B surface antigen using yeast or mammalian cell systems, it demonstrates a favorable safety profile. However, it serves solely as a prophylactic agent and cannot treat chronic hepatitis B; furthermore, its applicability is limited across different immune populations. Classified as a Category I vaccine under China’s National Immunization Program, it is provided free of charge to newborns, while adults must pay for vaccination out-of-pocket, with a unit price ranging from 100 to 200 RMB. The vaccine exhibits 95%–100% protective efficacy in newborns and children, but elicits a low immune response rate in adults and is ineffective for chronic hepatitis B virus carriers.
Johnson & Johnson's Novel Hepatitis B Vaccine, focusing on optimizing preventive efficacy, adapted for individuals of different age groups and genders, with strong immune adaptability. As an upgraded version of traditional vaccine technology, it has completed Phase III clinical trials. The trial results demonstrated that the vaccine can induce high levels of anti-HBV antibodies in the body, with a significantly lower infection rate compared to the control group. It exhibits a favorable safety profile, with mild and transient adverse reactions, offering a new candidate solution for global hepatitis B prevention.
Overall, the integrated therapeutic and prophylactic mRNA hepatitis B vaccine covered by this patent holds a core advantage over existing competitors by simultaneously addressing two major industry pain points: low immune response in adults and the functional cure of chronic hepatitis B. Having completed animal studies that validated protection across the entire population and long-term immune memory, it fills the market gap between traditional vaccines and single-mechanism innovative therapeutics in terms of technical positioning, thereby offering significant differentiated competitive advantages.