Group Introduction
[Its Dual-Listed Companies] Joincare Pharmaceutical Group (Stock Code: 600380 GDR Code：JCARE) Livzon Pharmaceutical Group (Stock Code: 000513 Hong Kong Stock Code: 01513)
vaccine
Livzon Bio's Likang V-01 recombinant COVID-19 protein vaccine (trade name: Likang ®) is a recombinant novel coronavirus fusion protein vaccine jointly developed by Livzon Mab and the Institute of Biophysics, Chinese Academy of Sciences. It is the first vaccine with Omicron protective efficacy data and has strong protective efficacy against the Omicron variant virus. It is a 2.0 upgraded version of the protein vaccine.
In September 2022, Livzon Bio's Likang V-01 was officially approved for inclusion in the emergency use of sequential booster immunization for novel coronavirus prevention and control after being reviewed by the National Health Commission and other departments, and was launched nationwide.
In December 2022, the Joint Prevention and Control Mechanism of the State Council's Leading Group on Novel Coronavirus Pneumonia Prevention and Control issued the "Implementation Plan for the Second Booster Immunization of COVID-19 Vaccines," and Livzon Bio's recombinant COVID-19 fusion protein vaccine (CHO cells) was selected as an optimal combination.
Product Advantages:
1. Preferred vaccine for sequential booster immunization—The first COVID-19 vaccine to obtain Omicron protective efficacy data from Phase III clinical trials. Livzon Bio's Likang V-01, through the first international multicenter, large-sample sequential booster protection efficacy Phase III clinical trial, obtained Omicron protective efficacy data. The results showed that the absolute protective efficacy of Livzon Bio's Likang V-01 reached 61.35%, with strong protection against Omicron, comparable to the absolute protective efficacy (62.5%) of Moderna's mRNA vaccine's self-booster immunization, reaching the international first-class level. Literature studies have shown that in terms of neutralizing antibody titers against Omicron: Livzon Bio's Likang V-01 sequential booster immunization based on inactivated vaccines is 4-8 times that of inactivated vaccine self-booster immunization, and 2-4 times that of other recombinant protein vaccine sequential booster immunizations.
2. Sequential booster immunization is safe and effective, which is of great significance to key populations, especially those aged 60 or older or with underlying diseases. Currently, sequential booster immunization is a key focus of epidemic prevention. Phase III clinical data of Livzon Bio's Likang V-01 sequential booster immunization show that the absolute protective efficacy for key populations (such as those aged 60 or older or with underlying diseases) is 61.19%, and the absolute protective efficacy for people with underlying diseases is 71.83%. Clinical results from over 30,000 subjects in 6 countries worldwide show that Livzon Bio's Likang V-01 has good overall safety, a low incidence of adverse events, and mainly mild and common vaccine adverse reactions. The incidence of adverse events in people aged 60 and over is lower than that in people aged 18-59. Given the current scattered and sporadic transmission of Omicron variants in China, booster vaccination, especially effective vaccination of key populations such as the elderly and those with underlying diseases, is crucial for epidemic prevention.
3. Advantages of a novel molecular structure—Fusion protein molecular design with globally innovative patented technology. Based on traditional protein vaccines, Livzon Bio's Likang V-01 uses DNA recombination technology to innovatively develop an IFNα-Pan-RBD-Fc fusion protein molecule with independent intellectual property rights (other recombinant protein vaccines on the market in China only have RBD dimers; Livzon Bio's Likang V-01 fuses biological adjuvants, Pan epitopes, and Fc fragments, etc., to the RBD dimer), which can rapidly activate and produce a lasting immune response and high-titer neutralizing antibodies. It is a 2.0 upgraded version of the recombinant protein vaccine.
4. Stable product, sufficient reserves, mature and advanced recombinant protein vaccine R&D technology platform, capable of rapid response to virus mutations. Livzon Bio's Likang V-01 is expressed by highly efficient Chinese hamster ovary (CHO) cells that express recombinant novel coronavirus fusion protein, and is produced through purification and formulation. The production process is safe, the technology is robust, and it is easy to scale up and mass produce; the product quality is excellent, and the finished product can be stored and transported at 2-8℃, and remains stable for 1 month at 40℃ and 6 months at 25℃ in short-term storage. There are sufficient reserves, and high-standard bulk and finished product commercialization workshops have been put into operation, with an annual production capacity of 1.5 billion doses. At the same time, Livzon has a mature and advanced vaccine platform technology, which can quickly respond to virus mutations and efficiently develop next-generation variant vaccines.
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