China's Centre for Drug Evaluation (CDE) has accepted domestic company Rhegen's investigational new drug (IND) application for RH119, the world's first lyophilised mRNA vaccine against tuberculosis (TB), classified as a Category 1.1 innovative biologic for diseases lacking effective prevention. TB caused 1.25 million deaths globally in 2023, with China ranking third in new cases at 741,000. The century-old BCG vaccine shows declining efficacy from 82% in children under 15 to 20% in adults aged 25 to 34, creating an urgent need for improved vaccines targeting adolescents and adults.

RH119 has demonstrated promising safety and immunogenicity in investigator-initiated trials since January. World Health Organization (WHO) modelling indicates successful TB vaccines could prevent 8.5 million deaths over 25 years while generating USD 440 billion in market revenue. Rhegen's candidate represents China's potential contribution to the goal of ending the TB epidemic by 2035.

PharmCube's NextBiopharm® database lists 9 institutions developing mRNA-based vaccines for TB. Click here to request a free trial for NextBiopharm®.