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• Time of issue:2019-03-07
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(Summary description)


Sinopharm Sinopharm Group China Biotech introduced the Omicron variant strain from the University of Hong Kong for the first time on the basis of the prototype new crown inactivated vaccine and the completion of the development of beta and delta variant inactivated vaccines in the early stage, December 2021 On the 9th, the research and development of the Austrian strain inactivated vaccine was quickly launched.

According to the guiding principles and research and development strategies of the improved new crown vaccine of the State Food and Drug Administration, Sinopharm Group China Biotechnology has completed the screening, passage and expansion of the Austrian strain by using the newly built P3 high-level biosafety laboratory, and established a three-level virus. The seed bank has completed process verification, preparation of multiple batches of large-scale products, quality standard research, safety evaluation in animals and immunogenicity research. titer of neutralizing antibodies. On March 3, 2022, the Beijing Institute of Biology of Sinopharm, Wuhan Institute of Biology and Hong Kong research institutions confirmed the clinical plan and related details. The clinical application materials were submitted to the Hong Kong Department of Health on the 1st, the ethics approval was obtained on April 12th, and the clinical research approval was obtained on April 13th, becoming the world's first inactivated vaccine of Chronomicron strains approved for clinical use.

At the same time of Sinopharm, Sinopharm Group Sino Bio began to submit domestic clinical application materials to the Drug Evaluation Center of the State Food and Drug Administration on a rolling basis from January 26 to start the technical review.

Sinopharm On April 26, Sinopharm China Bio-Beijing Biological Products Research Institute's Omicron variant new coronavirus inactivated vaccine obtained the clinical approval issued by the State Food and Drug Administration of China. Sinopharm Group China Biotechnology will use a randomized, double-blind, cohort study to conduct a sequential immunization clinical study in people aged 18 and over who have completed 2 or 3 doses of the new crown vaccine to evaluate the efficacy of the new crown virus of the Omicron variant. Safety and immunogenicity of live vaccines.

Sinopharm shoulders the political and social responsibilities of a central enterprise. Sinopharm Group China Bio has independently developed 4 new crown diagnostic reagents, 4 new crown specific treatment drugs and successfully developed three technical routes in the three fields of "diagnosable, curable and preventable". The four new crown vaccines have given full play to the role of the national team, main force and pillar of the pharmaceutical industry, created a strategic scientific and technological force to maintain national biosecurity, and promoted Chinese vaccines and therapeutic drugs to benefit the Chinese people and the world.