Shandong Xinbo helped Ruiji Biology to obtain the approval of the first freeze-dried tuberculosis mRNA vaccine in the world
2025/11/20
As an important partner in the research and development process, Shandong Xinbo strictly adheres to the guidelines of NMPA and ICH. With its profound accumulation in the field of preclinical safety evaluation of drugs, it has provided a complete set of preclinical safety evaluation techniques for the development of this innovative drug, helping partners to obtain clinical trial permits smoothly.
The prevention and control of tuberculosis has broken the situation and solved the double problems of prevention and control
The situation of tuberculosis prevention and control is urgent - a quarter of the world's population carries pathogenic bacteria, but the only widely used BCG vaccine has a protection period of only 15-25 years, and the adult protection is insufficient. Now the impasse has been broken. The freeze-dried tuberculosis mRNA vaccine RH119 precisely solves the pain points of traditional vaccines. Through the multi antigen combination design, the early IIT test showed the "double high" advantage: high safety among healthy adults aged 18-59 and people with latent infection, and can induce strong antigen specific cellular immune response, which can double guarantee the prevention of infection and prevent the onset of latent infection.
Innovation breakthrough: Freeze dried mRNA technology breaks the 'cold chain curse'
The Reggie Biotech RH119 vaccine adopts the world's leading freeze-dried mRNA technology and has three core advantages:
✅ The storage and transportation threshold has been significantly reduced: 2-8 ℃ can meet the demand under normal conditions, without the need for ultra-low temperature cold chains, significantly reducing global transportation and storage costs, especially suitable for resource limited areas;
✅ Significant improvement in application efficiency: Long term stable characteristics reduce vaccine expiration waste, simplify vaccination process planning, and enhance emergency response capabilities in public health emergencies;
✅ Comprehensive upgrade of immune protection: relying on independent intellectual property technology, the immune efficacy and cellular immune stimulation effect are better, and it is expected to achieve a protection level beyond the existing BCG vaccine.
Collaborative deep cultivation of vaccine research and development 'safety bottom line'
As an important partner of Reggie Biotech, Shandong Xinbo has been fully involved in the development of RH119 vaccine: conducting systematic toxicology research and immunogenicity evaluation on vaccine safety, laying a "safety bottom line" for Reggie Biotech's technological transformation; Based on the evaluation experience of multiple mRNA vaccines such as herpes zoster, respiratory syncytial virus, and novel coronavirus, accurate pharmacokinetic analysis methods are customized for vaccines, and advanced animal models are used to simulate human immune response, helping Ruiji Biotech optimize its clinical program; With over 100 varieties of evaluation experience and standardized processes, we ensure the completeness and reliability of preclinical data, becoming a key support for the efficient approval of vaccines.
This breakthrough is the result of complementary advantages between the two parties. Reggie Biotech deeply cultivates its core areas with its globally leading full chain mRNA technology platform, while Shandong Xinbo accurately supplements with its preclinical evaluation capabilities, helping to efficiently promote vaccine research and development. Both parties collaborate professionally to inject momentum into the high-quality development of the biopharmaceutical industry.
Shandong Xinbo's performance in preventive vaccines in the past 3 years
