Event: in April 3, 2022, the Shijiazhuang group announced that the New Coronavirus mRNA vaccine SYS6006 developed by the company has been approved by the State Administration of food and drug for clinical research. In April 4, 2022, Cansino Biologics Inc(688185) bio announced at the HKEx that the New Coronavirus mRNA vaccine developed by the group has been approved by the National Drug Administration’s clinical trial.
Covid-19 epidemic continues, and it is the general trend to strengthen vaccination in sequence.
Since March, Omicron mutant has spread rapidly in many places in China. As of April 4, 2022, 1366 locally diagnosed patients and 11862 asymptomatic patients have been added. With the repeated occurrence of covid-19 epidemic in all parts of China, with the approval of the joint prevention and control mechanism of the State Council, the National Health Commission began to deploy covid-19 vaccine to strengthen immunization in sequence. Covid-19 vaccine with different technical route from the first two injections can be used for the third injection. Sequential immunization with covid-19 vaccine has two main purposes: one is that different vaccines can complement each other; the other is that people have different side effects for different kinds of vaccines. Vaccination with different technical routes can avoid side effects.
The clinical development of domestic mRNA vaccine is in full swing
Due to its high antibody titer and expression characteristics, mRNA vaccine is expected to play an important role in sequential booster immunization. According to the results of recent clinical trials in Hong Kong, compared with three doses of Kexing inactivated vaccine, the antibody expression level produced by two doses of Kexing vaccine + mRNA booster is higher. At present, China has made rapid progress in the cooperation between Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) and biontech, tozinameran (China Phase II clinical), arcovax (China phase III clinical) of Aibo biology and lvrna009 (China Phase II clinical) of rivanda biology.
The incident was approved to carry out the clinical mRNA vaccine from the Cansino Biologics Inc(688185) bio New Coronavirus mRNA vaccine and the SYS6006 of the stone Pharmaceutical Group. According to the announcement, SYS6006 is a mRNA vaccine against the COVID-19 virus variant strain, which has good protective effect on the main mutation strains such as Omicron and Delta. At the same time, sys6006 has good stability and can be stored at 2-8 ℃ for a long time.
Cansino Biologics Inc(688185) biology has published three mRNA related patents with application publication numbers cn113215178a, cn113684219a and cn114149337a, covering the delivery technology of covid-19 related mRNA vaccine and preparation. Where CN113684219A inventions cover SARS? CoV? 2 and the mRNA sequence encoding RBD (receptor binding domain) in S protein or its variant. Cn114149337a and Jenkem Technology Co.Ltd(688356) jointly applied for 11 kinds of lipid compounds, which are mainly new ionizable lipids for nucleic acid delivery and their application in the delivery of bioactive substances. At the same time, according to the announcement of stone Pharmaceutical Group, sys6006 has realized internalized production and domestic production in the key production raw materials and auxiliary materials of mRNA technology, which can meet the demand of large-scale capacity supply.
MRNA industry chain is developing rapidly, and domestic substitution is imminent
According to the medical magic cube database, since 2017, there have been 54 mRNA vaccine related investment and financing events, including classic cases of single round financing of more than US $200 million, such as Aibo biology and Si microorganism. On January 1 this year, Messenger biology obtained millions of dollars of financing from angel round. The company established a complete mRNA drug R & D and large-scale production system by introducing the world’s leading LNP delivery technology, and rapidly developed new infectious diseases and tumor mRNA vaccines. On March 28, convinced biology obtained 120 million US dollars in round B financing, which is mainly responsible for building LNP technology platform, designing and constructing various ionizable phospholipids.
According to the previous calculation of the University of Pennsylvania, plasmids, capping enzymes, t7rna polymerase and various lipids account for the main part of the cost of consumables in the production of mRNA vaccine. According to the announcement of Cansino Biologics Inc(688185) biology and Petrochemicals Group, at present, the key raw materials and production processes in the mRNA industry chain have been gradually internalized and domestically produced. With the continuous expansion of technologies of mRNA related companies in China, domestic substitution is imminent.
Investment suggestion: with the continuous recurrence of epidemic situation and the national support for the sequential strengthening of vaccination policy of covid-19 vaccine, the clinical progress of domestic mRNA vaccine is expected to accelerate. We focus on domestic mRNA vaccine targets with mature pipelines and independent intellectual property rights, such as Cansino Biologics Inc(688185) biology, Shijiazhuang Pharmaceutical Group, etc; At the same time, we mainly recommend domestic mRNA upstream industry chain targets, such as Kingsley biotechnology, Nanjing Vazyme Biotech Co.Ltd(688105) , Jenkem Technology Co.Ltd(688356) , etc.
Risk warning: policy change risk; R & D is less than expected risk; Regulatory risk
