Events
From April 3 to 4, Shijiazhuang Pharmaceutical Group and Cansino Biologics Inc(688185) biology successively announced that the mRNA covid-19 vaccine developed against the mutant strain was approved by the State Food and drug administration to carry out clinical trials.
Commentary
Cansino Biologics Inc(688185) biological mRNA covid-19 vaccine has good preclinical research results, and can produce high titer neutralizing antibodies against current epidemic variants Cansino Biologics Inc(688185) biological mRNA covid-19 vaccine is a new generation vaccine with better protective effect against existing mutant strains. According to the company’s announcement, the preclinical results show that the vaccine can induce high titer neutralizing antibodies against a variety of important variants identified by the WHO (including the current epidemic strain). Compared with the existing covid-19 vaccine developed based on the prototype strain, it has a wider spectrum and can more effectively protect the body from the infection of existing variants. The company targets international biomedical enterprises at the forefront of this field and is expected to have important localization substitution value after completion. According to the company’s official wechat, the company has laid out mRNA synthesis and delivery technology for many years, and has applied for a number of patents on mRNA vaccine design and new delivery system design. The mRNA technology platform of the company has independently designed and developed sequence optimization software, which can obtain the key sites affecting stability and the optimal sequence to effectively improve the antigen expression. The CMC process is simple and conducive to industrialization.
The preclinical study of mRNA covid-19 vaccine of Shijiazhuang Pharmaceutical Group showed good protective efficacy and safety, and the domestic substitution of key supply chain raw materials was realized. According to the announcement of the company, the mRNA covid-19 vaccine sys6006 of China Pharmaceutical Group is an mRNA vaccine independently developed for covid-19 virus mutant strain. Through targeted antigen mutation design, preclinical research shows that it has good immune protection against the current mainstream mutant strains including Omicron and delta. In addition, the safety has also been proved by preclinical safety evaluation data. Sys6006 uses advanced production technology and has strong industrialization ability; It has good stability and can be stored at 2-8 ℃ for a long time. In addition, in the supply chain, the company has achieved internalized production and domestic substitution for the key production raw materials and auxiliary materials of mRNA technology, which can meet the demand of large-scale production capacity supply. Based on the comprehensive advantages of many aspects, sys6006 was included in the special approval procedure by nmpa and quickly approved to enter the clinic. The follow-up company will fully promote the Chinese and international multi center clinical research of the product and strive to be listed as soon as possible.
The technical advantages of mRNA platform are constantly verified, and the breakthrough progress of subsequent milestone nodes is paid attention to. We pointed out in the industry in-depth report “nucleic acid vaccine, innovative future” that mRNA technology platform has unique advantages and is one of the main directions of vaccine technology platform research and development in the future. The new mRNA vaccine can be designed, synthesized and prepared rapidly at the R & D end, with multiple advantages such as high efficiency and flexibility; At the production end, it has the advantages of rapid production, low production cost and easy to carry out large-scale production in vitro. In terms of new vaccine research and development, mRNA vaccine has a relatively fast development speed for mutant strains and shows a relatively good protective effect. Therefore, an important milestone in the clinical promotion of mRNA covid-19 vaccine is worthy of attention. If the subsequent clinical marketing progress of covid-19 mRNA vaccine is smooth, it is expected to add new means to epidemic prevention and control and bring new catalysis to the industry. In addition, mRNA platform technology can be used to develop a variety of different vaccines. The milestone progress in the field of conventional infectious diseases and therapeutic tumor vaccines such as herpes zoster vaccine, rabies vaccine and influenza vaccine is also worthy of attention.
Investment advice
We are optimistic about the future market prospect of mRNA vaccine. We suggest paying attention to leading companies with forward-looking strategic layout and innovative technology ability, Chongqing Zhifei Biological Products Co.Ltd(300122) , Cansino Biologics Inc(688185) biology, stone Pharmaceutical Group, Walvax Biotechnology Co.Ltd(300142) , Shenzhen Kangtai Biological Products Co.Ltd(300601) etc.
Risk tips
R & D fails or R & D progress does not meet expectations; Risk of adverse reactions; Covid-19 strain mutation risk; Intensified market competition; Independent and controllable risks of the supply chain.
