· 96.0% effective against severe disease 14 days post-vaccination for population aged 18 and above.

· Single-dose vaccine received approvals in at least 10 markets including China, Mexico, Ecuador, Chile, Argentina, Hungary, Kirghizstan, Pakistan, Indonesia and Malaysia.

Tianjin, December 23, 2021 – CanSino Biologics Inc. (“CanSinoBIO”) (SSE: 688185, HKEX: 06185) today announced that The Lancet^[1] published its Phase III clinical trial results on the safety and efficacy of its Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (“Ad5-nCoV”, trade name: Convidecia™). The publication of the analysis showed that a single dose of Convidecia™ is efficacious and safe with an efficacy of 96.0% in preventing severe COVID-19 disease and an overall efficacy of 63.7% 14 days post-vaccination for healthy adults aged 18 and above, without any reported vaccine-related serious adverse events. 

“We are thrilled to have our Phase III trial results fully disclosed and published in The Lancet, one of the world’s most prestigious peer-reviewed medical journals. This represents another milestone and provides further evidence of the strong protection provided by our single-dose vaccine, which is now approved in at least 10 markets across multiple continents. CanSinoBIO remains committed to our mission of providing affordable, timely and mass immune protection to the global population, and will continue to collaborate with partners in the public and private sectors to improve vaccine access and have more people benefit from our technology breakthroughs,” said Dr. Xuefeng YU, Chairman and Chief Executive Officer of CanSinoBIO.

CanSinoBIO’s Phase III clinical trial is a global multicenter, randomized, double-blind and placebo-controlled study in Argentina, Chile, Mexico, Pakistan and Russia and enrolled 45,000 volunteers globally, representing the same sample size as that of other leading global vaccine manufacturers.

The Phase III trial results met all of the study’s primary efficacy endpoints and indicated an overall efficacy rate of 63.7% (95% CI 52.9-72.1) and an efficacy rate of 96.0% (95% CI 70.5-99.5) against severe disease 14 days after receiving a single dose of Convidecia. The overall efficacy rate 28 days post-vaccination was 57.5% (95% CI 39.7-70.0), with an efficacy rate of 91.7% (95% CI 36.1- 99.0) against severe disease. The results met the efficacy rate requirement of the World Health Organization for COVID-19 vaccines. Additionally, the trial proved the safety of Convidecia for a broad range of age groups above 18, including those over the age of 60.

In addition to significantly shortening the vaccination cycle, Convidecia™ can be stably transported and stored between 2°C and 8°C, making it more accessible to regions with insufficient storage facilities and medical resources, reducing the burden placed on healthcare systems and medical workers, and contributing to building broad immune protection globally by leveraging the advantages of its single-dose regimen.

CanSinoBIO has also seen encouraging data in the trial of a booster dose of Convidecia™ for people inoculated with two doses of inactivated vaccines. Data showed that administering a booster dose of Convidecia™ could result in an approximately 78-fold increase in neutralizing antibody level 14 days post-vaccination^[2]. Additionally, administering a homologous booster dose of Convidecia™ six months after the prime immunization could result in a 7-fold increase in neutralizing antibody level.

In addition, CanSinoBIO has made notable progress in the development of its Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for inhalation. Studies showed that a combination of intramuscular and inhaled regimen of Convidecia™ provides stronger protection than a single intramuscular dose. The neutralizing antibody level 28 days after the mixed regimen was four times higher than that of a single intramuscular injection, which could remain at a high level after 6 months.

CanSinoBIO’s inhaled version of its COVID-19 vaccine Convidecia™ can be inhaled through the respiratory tract and lungs, thereby stimulating mucosal, humoral and cellular immunity with added layer of protection. CanSinoBIO is committed to continuing to explore the optimal COVID-19 vaccination strategy for the world, making continuous contributions in the global fight against the pandemic.

References：

[1]https://doi.org/10.1016/S0140-6736(21)02753-7

[2]https://doi.org/10.1101/2021.09.03.21263062.