February 25, 2021
National Medical Products Administration (NMPA) of China has approved an application for conditional marketing authorization of the Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (“Ad5-nCoV”, trade name: Convidecia™) . CanSino Biologics Inc. (“CanSinoBIO”) (SHSE: 688185, HKEX:06185) filed the application on February 21.
As part of the regulatory process, CanSinoBIO will continue to carry out relevant clinical research work, fulfill the conditional requirements, and submit follow-up research results to the NMPA in a timely manner.
The interim analysis data of the phase III clinical trial of Convidecia™ shows that the vaccine candidate has an overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single dose vaccination, and 68.83% at preventing all symptomatic COVID-19 disease 14 days after single dose vaccination. Ad5-nCoV has an efficacy of 90.07% at preventing severe disease 28 days after single dose vaccination, and 95.47% at preventing severe disease 14 days after single dose vaccination.
The data is supportive of the fact that the efficacy of Convidecia™ has met the relevant technical standards laid out by the World Health Organization and relevant standards and requirements set out in ‘Guiding Principles for Clinical Evaluation of Novel Coronavirus Preventive Vaccines (Trial Implementation)’ issued by the NMPA.
Convidecia™ is currently the only COVID-19 vaccine candidates that applies single-dose regime among other front-runners in China. It is the ideal candidate that is capable of providing immune protection in a timely manner. Since it is built upon adenovirus-based viral vector vaccine technology platform that has successfully developed the Ebola vaccine, Convidecia™ can be stably stored and transported between 2°C and 8°C, making it more accessible especially to the regions with underserved public health.
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 investigational Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector). Additional information can be found online at www.cansinotech.com.