23 March 2021 | News
Marks vaccine's first approval by a European Union member state, following Mexico, Pakistan and China
Photo Credit: Freepik
CanSinoBIO Biologics Inc. 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.
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.