CanSinoBIO Announces Approval for its Single-Dose COVID-19 Vaccine Convidecia™ in Hungary

• Marks vaccine's first approval by an European Union member state, following Mexico, Pakistan and China
• Continues to boost production capacity to meet increasing demand
• Safe, stable storage and transportation between 2°C and 8°C, accessible by under-developed regions
• 95.47% effective overall in preventing severe COVID-19 diseases 14 days after vaccination
• Vaccines provide timely mass protection for adults aged 18 and above, including those over 60

TIANJIN, China, March 22, 2021 /PRNewswire/ -- CanSinoBIO Biologics Inc. ("CanSinoBIO") (HKEX: 06185) today announced that the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI) granted emergency use authorization for its Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) ("Ad5-nCoV", trade name: Convidecia™). The approval is based on the vaccine's interim results for Phase III clinical trial and marks the first approval of Convidecia™ in an European Union member state.

"We are pleased to see the authorization by the Hungarian authority for our vaccine, which marks an important step forward in the global fight against the COVID-19 pandemic. As CanSinoBIO continues to receive approvals from various governments across different continents, we are focusing on ramping up production capacity to deliver our one-shot vaccines quickly and safely to countries that are in desperate need of mass protection from this pandemic," said Dr. Xuefeng YU, Chairman and Chief Executive Officer of CanSinoBIO.

On February 25, 2021, Convidecia™ was granted a conditional marketing authorization by the National Medical Products Administration of China ("NMPA"), the first of its kind authorized in China. Globally, Convidecia™ received authorization for emergency use by the Federal Commission for Protection against Sanitary Risks of Mexico and the Drug Regulatory Authority of Pakistan for adults aged 18 and above in February 2021.

Convidecia™ Production, Access and Distribution

The Company continues to invest in and expand its production capacity by building its own manufacturing facility and partnerships to meet the increasing demand of Convidecia™. In August 2020, CanSinoBIO entered into a strategic partnership with Shanghai Pharmaceuticals, China's second largest pharmaceutical company, in fast expanding production capacity, storage and supply chain management of COVID-19 vaccines.

CanSinoBIO has signed a purchase agreement with Mexico to supply 35 million doses. The Company has also been discussing with authorities in Pakistan, Malaysia, Hungary and many other countries about delivery and distribution with local partners of millions of doses in the future.

Benefits of Single-Shot Regimen

CanSinoBIO is committed to bringing affordable, timely and mass immune protection to the global population by significantly shortening the vaccination cycle and reducing the burden placed on healthcare systems and medical workers.

Convidecia™ provides protection against severe COVID-19 disease and prevention of COVID-19-related medical interventions for a broad range of age groups above 18, including those over the age of 60.  

Convidecia™ can be stably transported between 2°C and 8°C and stored for at least three months. It is estimated to remain stable for over two months at 25°C and for over three weeks at 37°C, making it more accessible to regions with insufficient storage facilities.

Multi-center Study Provides Phase III Efficacy Data

Since September 2020, CanSinoBIO has been conducting a multicenter Phase III clinical trial in Pakistan, Mexico, Russia, Chile and Argentina and dosed more than 40,000 volunteers over 18 years old. The trial was led by global principal investigators ("PI"), global co-PIs and country co-PIs from seven countries including Canada, Mexico and Russia, and strictly complies with high ethical standards and rigorous scientific principles.

The interim analysis and data of the Phase III clinical trial disclosed by NMPA, reflect that Convidecia™ was 65.28% effective overall in preventing all symptomatic COVID-19 disease 28 days post-vaccination, and 68.83% in preventing all symptomatic COVID-19 disease 14 days post-vaccination. Convidecia™ has an efficacy of 90.07% in preventing severe COVID-19 disease 28 days post-vaccination, and 95.47% in preventing severe COVID-19 disease 14 days post-vaccination. The Phase III clinical trial results announced by the Pakistani authority showed an efficacy rate of 100% against severe COVID-19 disease and 74.8% at preventing all symptomatic COVID-19 disease in Pakistan.

"We are encouraged by the results announced by the countries where we have been conducting clinical trials of our vaccine. We appreciate the dedication and support from the global principal investigators, co-principal investigators, volunteers, governments and everyone else who has been contributing throughout the process," said Dr. Tao ZHU, Executive Director and Chief Scientific Officer of CanSinoBIO.

In early 2020, Convidecia™ was the first candidate vaccine to publish positive results from Phase I and Phase II clinical studies in The Lancet, one of the world's most distinguished medical journals. In August 2020, CanSinoBIO became the first company in China to be granted a patent for its COVID-19 vaccine in China. CanSinoBIO plans to publish its Phase III results in a peer-reviewed medical journal in due course.

About CanSinoBIO

Incorporated in 2009, CanSinoBIO (SHSE: 688185, HKEX: 06185) commits to research, production and commercialization of innovative vaccines for China and global public health security. It possesses four integrated platform technologies including adenovirus-based vectors, conjugation, protein design and recombination and formulation. As of today, it has established a robust pipeline of 16 vaccines preventing 13 diseases, including a globally innovative Ebola virus vaccine (Adenovirus Type 5 Vector) approved in 2017 as well as the Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) conditionally approved in 2021. Additional information can be found online at www.cansinotech.com