CanSino Biologics Inc. announced on November 13th that the Phase I clinical trial for the inhaled tuberculosis (TB) vaccine (Adenovirus Type 5 Vector) ("inhaled TB Booster") developed by the Company was officially initiated in Indonesia recently and the first trial patient case of the Phase I clinical trial has been formally enrolled. This milestone marks an important step forward in the global development of this innovative tuberculosis vaccine.

CanSinoBIO Chairman and CEO Dr. Xu Xuefeng stated: "As a company committed to innovative vaccine development, we aim to contribute to global TB control and elimination. The initiation of this Phase I trial represents a key milestone for our inhaled TB booster vaccine and demonstrates CanSinoBIO’s ongoing commitment to advancing innovative vaccines for global access."

Tuberculosis remains a major global public health problem. According to the World Health Organization Global Tuberculosis Report 2025¹, there were an estimated 10.7 million new tuberculosis cases worldwide in 2024. Most of the people who develop tuberculosis disease each year are in 30 high tuberculosis burden countries: they accounted for 87% of the global total in 2024. The top eight (67% of the worldwide total) were India (25%), Indonesia (10%), the Philippines (6.8%), China (6.5%), Pakistan (6.3%), Nigeria (4.8%), the Democratic Republic of the Congo (3.9%) and Bangladesh (3.6%).

Currently, Bacillus Calmette-Guerin is the only available tuberculosis vaccine in the world and is widely vaccinated globally, playing an important role in the prevention of tuberculosis in infants and children. However, the efficacy of Bacillus Calmette-Guerin declines over time and it is unable to enhance vaccine protection through booster dose for vaccination. To address this deficiency, the Company has developed the first generation of a globally innovative tuberculosis booster vaccine ("TB Booster") for the Bacillus Calmette-Guerin-vaccinated population. 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 Bacillus Calmette-Guerin booster vaccine, as well as its superiority of mucosal immunity.

Based on the accumulation of technology in the development of COVID-19 vaccine for inhalation, the Company has established a complete inhalation pharmacy and quality control system, upgraded the first generation of product, and also increased the antigen components to develop inhaled TB Booster, which is delivered through aerosol inhalation, and it is expected to be able to stimulate the immune response in lungs, so as to clear tuberculosis bacilli and control latent infection, and to achieve the effect of preventing infections.

In May 2025, the vaccine received clinical trial approval from Indonesia’s Food and Drug Authority (BPOM). The Phase I clinical trial was conducted in Indonesia to investigate the safety and immunogenicity of a single dose of inhaled TB Booster in adults aged 18 to 49 years.

Looking ahead, CanSinoBIO remains committed to its mission of providing innovative, high-quality, and affordable vaccines for global public health, advancing scientific innovation and international collaboration to contribute to the global goal of ending tuberculosis.

References：

1.Global Tuberculosis Report 2025: Top findings and messages
https://www.who.int/zh/publications/m/item/global-tuberculosis-report-2025--top-findings-and-messages