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艾美疫苗(06660)进入密集申报大年,mRNA技术平台布局多个爆款疫苗

The Le Méridien vaccine (06660) has entered a major year of intensive reporting, and the mRNA technology platform lays out multiple popular vaccines

Zhitong Finance ·  Mar 27 20:04

The Zhitong Finance App learned that on March 28, Emmy Vaccine (06660) released the 2023 results and several major new product development announcements. The data...

The Zhitong Finance App learned that on March 28, Le Méridien Vaccine (06660) released its 2023 results and several major new product R&D announcements. The data showed that the company continued to maintain a high growth rate of R&D investment, with R&D expenses exceeding 636 million yuan in 2023, an increase of 27.2% over the previous year. New products developed have entered the harvest period one after another. In 2024, the company expects that 3 products, including the 13-valent pneumonia-conjugate vaccine, will be declared for marketing, and 7 products, including the 20-valent pneumonia-conjugate vaccine and the novel high-cost human diploid vaccine, will be declared clinical.

According to the latest announcement, the quadrivalent MDCK cell influenza vaccine currently being developed by the company has submitted a pre-application for clinical trials. Currently, all influenza vaccines marketed domestically are produced based on the chicken embryo process, and no influenza vaccine based on a cellular matrix has been approved for marketing. Due to the high variability of the influenza virus, Le Méridien uses MDCK cells to replace chicken embryos for cultivation. The production cycle is short, there is no problem of unstable supply of raw materials, and the ability to cope with virus mutations is strong. It can be automated and cultivated on a large scale in bioreactors. The risk of contamination is low, and it is easy to be industrialized on a large scale. Therefore, it is possible to produce products for seasonal strains announced by WHO to better meet the needs of public health. Furthermore, the chance of virus mutation during transmission is low, egg albumin is not included, and the risk of allergies is significantly reduced.

According to the annual report, by the end of 2023, the Emmy vaccine had obtained a total of 14 clinical approvals and carried out 21 clinical trials. Of these, 5 have completed phase III clinical trials, 5 production workshops for phase III clinical vaccine products have been basically completed, and all preparations before marketing are underway. Up to now, the 13-valent pneumococcal conjugate vaccine (PCV13) has completed full phase III clinical immunization, and pre-trial application materials have been submitted to the State Drug Administration; the 23-valent pneumococcal polysaccharide vaccine (PPSV23) and phase III clinical trials of the serum-free iterative rabies vaccine have been fully vaccinated; the world's first innovative vaccine EV71-CA16 bivalent hand, foot and mouth vaccine (human diploid cells) has obtained clinical approval; mRNA iterative rabies vaccine is the first non-mRNA vaccine product accepted domestically.

Emmy Vaccine has now commercialized eight vaccine products. Among them, Hanson's yeast recombinant hepatitis B vaccine and Vero cell freeze-dried human rabies vaccine are in a leading position in the market. In the future, as hepatitis B vaccination completely shifts from neonates to vaccination promotion for the entire population, the company's sales revenue will usher in a new increase. The company will soon launch serum-free iterative rabies vaccine, novel high-cost human diploid rabies vaccine, and mRNA iterative rabies vaccine products, leading the in-depth technological iterative upgrading of global rabies vaccines and enhancing the company's competitiveness in the rabies vaccine market.

It is worth noting that the mRNA vaccine technology platform and products laid out by the company are in a leading position in the industry. Clinical trial data from tens of thousands of subjects has fully verified the safety and efficacy of the platform's products, and many popular and major single-product vaccines are already advancing at an accelerated pace.

The mRNA iterative rabies vaccine developed by the company on this platform has been proven through extensive animal testing. Compared with traditional rabies vaccines through virus culture, it has the characteristics of significantly fewer vaccinations, higher protective neutralizing antibodies, significantly faster production, and strong immunity durability, providing a better choice for improving the level of rabies prevention and control. Meanwhile, the mRNA RSV and mRNA shingles vaccines being developed by the company are all major single-product vaccines in the world, and clinical trial applications are expected to be completed in 2024. In the future, Le Méridien Vaccine will continue to promote mRNA vaccine innovation based on this, focusing on unmet clinical needs in core disease fields and further enhancing core competitiveness.

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