\u3000\u3000 Livzon Pharmaceutical Group Inc(000513) (000513)
Events. The recombinant New Coronavirus fusion protein vaccine (V-01), which was jointly operated by Affiliated Companies and the Institute of Biophysics, China Academy of Sciences, has completed the interim master data analysis of the sequential III phase clinical trials and obtained key data.
Viewpoint:
Adjuvant antigen integrated design, v-01 opens a new idea of high-efficiency anti epidemic. V-01 molecule is composed of interferon, pan epitope, RBD dimer and Fc fusion protein. The biological adjuvant antigen integrated design of i-r-f bypasses the production and safety problems of new adjuvants and minimizes the dependence on external adjuvants. IFN fusion induces Th1 biased cellular immunity, combined with common alum adjuvants, which can reduce the probability of severe toxicity and slowly release i-r-f molecules into draining lymph nodes (DLN). Due to the fusion of human interferon as a biological adjuvant in the antigen structure, v-01 can significantly improve the level of neutralizing antibody against covid-19 virus and activate the body to produce an effective cellular response.
The sequential strengthening scheme shows its superiority and good protection effect for Omicron. The phase III clinical trial of v-01 in Pakistan and Malaysia has enrolled 10241 cases, and the absolute protective power of sequential enhancement is 61.35%, which has significant strong and excellent effect and meets the WHO standard; In addition, 60 covid-19 virus genotyping and first-generation sequencing of all valid samples in this test are Omicron (the rest are still undergoing second-generation sequencing), which has good protection against infection caused by Omicron mutant strains. In addition, v-01 did not find any safety problems worthy of attention, and its use safety was good.
V-01 has excellent immunogenicity, safe use and bright early clinical data. The phase II clinical trial data of two doses of v-01 vaccination were published in Chinese medical journal in July 2021. The test results showed that two doses of v-01 stimulated significant immune response and obtained considerable high titer neutralizing antibody and anti RBD IgG antibody; Vaccination safety is good, especially in the elderly group, the overall incidence of vaccine related adverse events is lower than the corresponding adult group. V-01 vaccine has excellent immunogenicity and safety.
V-01 has a first mover advantage in the technical route of covid-19 vaccine recombinant protein, and has a broad application market at home and abroad. At present, China’s recombinant protein covid-19 vaccine has not been approved for marketing with conditions, one has been approved for emergency use, and eight are in the stage of clinical research. The global phase III multi center clinical trial project of v-01 recombinant protein vaccine is progressing smoothly, and the two clinical trial schemes have been declared by many countries. The results of this key data analysis actively and more effectively promote the R & D process of v-01. After being successfully approved and listed, it will provide vaccine support for global immunization.
The localization of materials and the continuous and stable supply of v-01 will provide strong support for China’s epidemic prevention and control. The v-01 recombinant protein vaccine has been developed rapidly, with bright data on safety and effectiveness, and can take into account the elderly; Reliable process quality and high localization rate of materials can realize continuous and stable mass supply. We expect that the company will rapidly promote the listing application of v-01 vaccine in China and actively ensure the smooth progress of covid-19 epidemic prevention and control in China.
Profit forecast and rating. Regardless of the amount of vaccine, it is estimated that the net profit attributable to the parent company from 2021 to 2023 will be 1.801 billion yuan, 2.075 billion yuan and 2.439 billion yuan respectively, with an increase of 5.0%, 15.2% and 17.5% respectively. EPS is 1.92 yuan, 2.21 yuan and 2.60 yuan respectively, and the corresponding PE is 19x, 17x and 14x respectively. We are optimistic about the long-term development of the company and maintain the “buy” rating.
Risk warning: R & D progress is not as expected; Product demand is less than expected; There are differences in individual response rate of vaccine; The products shall comply with the cooperative research and development agreement.
