Tianjin, 15 May 2025 - CanSino Biologics Inc (“CanSinoBIO” or  “the Company”) is pleased to announce that it has obtained clinical trial approval from the Badan Pengawas Obat danMakanan, Republik Indonesia to initiate a clinical trial for its Inhaled Tuberculosis Vaccine (Adenovirus Type 5 Vector) (the “inhaled TB Booster”) .

Tuberculosis (TB) has likely become the leading cause of death worldwide from a single infectious agent. It was also a major cause of deaths related to antimicrobial resistance. According to the World Health Organization (WHO), approximately 10.8 million people fell ill with TB , and a total of 1.25 million people died from TB in 2023 globally. Additionally, multidrug-resistant TB (MDR-TB) remains a serious public health crisis and a health security threat, with only about 2 in 5 individuals with drug resistant TB accessing treatment in 2023. Therefore, it is crucial to promote TB vaccine, which is the most effective and efficiency way to combat this infectious disease.

Currently, the traditional Bacillus Calmette-Guerin vaccine (BCG vaccine), also the only available tuberculosis vaccine in the world, is typically administered at birth. Additionally, the BCG vaccine declines over time and cannot enhance vaccine protection through booster doses, resulting in limited protection for adults. To address this deficiency, the inhaled TB vaccine is the first generation of a globally innovative tuberculosis booster vaccine for the BCG vaccine.

The inhaled TB Booster is designed to be administered via inhalation, inducing stronger immune responses in the respiratory tract and the lungs—the primary site of tuberculosis infection. This needle-free delivery method aims to clear tuberculosis bacilli and control latent infection, potentially achieving the effect of preventing infections and marking a breakthrough in tuberculosis prevention.

The Phase Ia and Phase Ib clinical trials for TB Booster were completed in Canada, and the clinical trial data demonstrated its safety and its effectiveness as a booster for BCG vaccine, as well as its superiority of mucosal immunity. The upcoming clinical trial in Indonesia will assess the inhaled TB Booster’s safety and immunogenicity of a single dose in adults aged 18 to 49 years.

CanSinoBIO is committed to advancing global health through innovation in vaccine delivery platforms, particularly for diseases that disproportionately affect the world’s most vulnerable populations.