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On December 1, CSPC Pharmaceutical Group (1093.HK) announced that upon the recommendation of the National Health Commission of the People's Republic of China and the approval of the National Medical Products Administration, the new coronavirus bivalent (XBB.1.5+BQ. 1) The mRNA vaccine (SYS6006.32) (this product) is included in emergency use in China to prevent disease (COVID-19) caused by novel coronavirus (SARS-CoV-2) infection.
SYS6006.32 is a new coronavirus bivalent mRNA vaccine containing XBB.1.5 and BQ.1 mutant strains developed by the Group based on the first-generation new coronavirus mRNA vaccine (trade name: Duentai) that has been included in the national emergency use. It is for mRNA vaccines for mainstream mutant strains represented by XBB.1.5. Clinical trials of
show that this product has very high immunogenicity against mainstream EG.5 and 4.9 and 5.0 times, and can have broad-spectrum cross-immunity against mutant strains including XBB.1.16, BA.5, XBB.2.3 and BA.2.86, suggesting that this product is effective against current major epidemic strains and possible future epidemic strains. Has a very good protective effect. This product has good safety, and the types and extent of major adverse reactions are comparable to those of Duentai, without adding new risks. Compared with the adult population, the level of neutralizing antibodies produced by the elderly population is similar, but the safety is better, suggesting that this product may have a better protective effect on the elderly population.
This product adopts advanced process technology with independent intellectual property rights, and has the advantages of stronger production capacity, better process reproducibility, and easy amplification and large-scale production. The product has good quality consistency and all batch samples submitted to the China Institute for Food and Drug Control have passed the test results; the product has good stability and can be stored at 2-8°C for a long time. The key raw materials and excipients used in production, such as core lipids and cap analogs for mRNA preparation, are produced by the Group. Other excipients and key equipment are domestically produced, and there is no need to rely on overseas suppliers in the supply chain.
This product is another mRNA vaccine product approved for emergency use after Duentai, which proves the research and development strength of the Group’s nucleic acid platform. The Group will actively promote the development of other products on this platform.
Source of article: CSPC Pharmaceutical Group
