CanSinoBIO Receives European GMP Certification for its COVID-19 Vaccine Convidecia™
- A major step for introducing Convidecia™ to more countries and people in need for protection
- Vaccine has been approved in China, Mexico, Pakistan, Hungary and Chile
- Provides timely clinical protection for adults aged 18 and above, including those over 60
TIANJIN, China, May 24, 2021 /PRNewswire/ -- CanSino Biologics Inc. ("CanSinoBIO") (SHSE: 688185, HKEX: 06185) today announced that its Recombinant Novel Coronavirus Vaccine, (Adenovirus Type 5 Vector) ("Ad5-nCoV", trade name: Convidecia™), has been granted a Good Manufacturing Practice ("GMP") certificate by the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI). The certification was issued on May 21, 2021 after a thorough inspection of CanSinoBIO's production of Convidecia™.
The GMP certificate recognizes that CanSinoBIO's manufacturing facilities and quality control system comply with the high production standards and guidelines required by the European Union ("EU"). The EU GMP certification is required to import COVID-19 vaccines into the European Union and is regarded as a recognition of leading industry standards by many authorities outside of the EU. This certification signifies CanSinoBIO's readiness to enter more markets in Europe and globally.
"We are pleased to receive the GMP certificate by the European Union, which is a testament to our capability to safely and reliably produce COVID-19 vaccines when many countries around the world are still in desperate need of mass protection from this pandemic. We will continue to support the supply of COVID-19 vaccines to China and other markets and contribute to the global fight against the pandemic by protecting more people's lives," said Dr. Xuefeng YU, Chairman and Chief Executive Officer of CanSinoBIO.
CanSinoBIO opened a new vaccine production site in Tianjin, China, with the expectation to produce over 200 million doses of Convidecia™ per annum. It will continue to expand its manufacturing capacity by collaborating with other top-tier pharmaceutical companies in China, including Shanghai Pharmaceuticals Holding Co., Ltd., to better meet the growing global demand.
In March 2021, CanSinoBIO started the phase I clinical trial of an inhaled version of Convidecia™ immediately after receiving the approval from the National Medical Products Administration of China, marking another milestone in bringing more acceptable, affordable, timely and mass immune protection to the global population and reducing the burden placed on healthcare systems and medial workers.
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
SOURCE CanSino Biologics Inc.
Company Codes: HongKong:6185, Shanghai:688185