Shanghai Company's Self-Developed COVID-19 mRNA Vaccine Approved For Clinical Trials And mRNA Vaccines Animal Trials

April 29, 2022, China's State Council Information Office held apress conference in Beijing. At the press conference, Lei Zhenglong, head ofthe Disease Control Bureau of the National Health and Wellness Commission, saidthat China's fastest progressing mRNA vaccine is currently undergoing phase IIIclinical trials outside of China.

(SMC) has recently received approval from the State DrugAdministration of China to conduct clinical trials and mRNA vaccines animaltrials for its COVID-19 mRNA vaccine. The vaccine that was approved forclinical trials and mRNA vaccines animal trials is an iteration of the vaccinedeveloped by SMC. The vaccine is designed to include the D614G mutation, whichis found in many COVID-19 strains such as Delta and Omicron, and has a broadspectrum of protection against current COVID-19 strains.

mRNA is a natural molecule that can send instructions to human cellsto create target proteins or antigens to stimulate the body's immune response. mRNAcarries the genetic information encoded by proteins and can be translateddirectly into proteins when delivered to the ribosomal machinery, hence thename "messenger RNA". Compared with traditional inactivated and liveattenuated vaccines, the development of mRNA vaccines is easier and moreefficient. However, the development of this new vaccine is technicallychallenging. mRNA is easily degraded if it enters the human body directly, andan LPP nano-delivery system is needed to encapsulate mRNA in safe anddegradable nanoparticles. The nano-delivery system is one of the biggesttechnical barriers.

It is understood that SMC was established in 2016, and is one of theinnovative companies that are the first to carry out mRNA drug development and mRNAtumor precision vaccines human clinical trials and mRNA vaccines animal trialsin China. Relying on the mRNA lipid polymorph nano-delivery technology platform(LPP/mRNA) with independent intellectual property rights, SMC has made acomprehensive layout in the fields of human preventive vaccines, tumorvaccines, antibody drugs, animal health care, protein replacement therapy andmedical aesthetics. We have mastered the core technology of mRNA vaccine andhave the exclusive global rights of LPP nano-delivery system; we have theself-developed antigen analysis, prediction and sequence optimization platform;we have the core patents of key technology/equipment for mass production of mRNAvaccine with annual production capacity of hundreds of millions of doses, andwe have completely achieved domestic substitution of key materials.

Currently, more than 90% of SMC's materials are domesticallyproduced; the scaling-up process can achieve large-scale mass production; SMCuses AI to optimize sequencing, with huge production and market potential.Baidu Research Institute and SMC have cooperated on the development of COVID-19mRNA vaccine with AI sequence optimization algorithm, and developed anefficient algorithm specifically for designing optimized mRNA sequences.

Mr. Li Hangwen, the founder and chairman of SMC, introduced that SMChas established modern production plants in Zhoupu and Fengxian, Shanghai,which can realize large-scale quantitative production. The annual productioncapacity of the two plants is expected to reach 400 million doses. SMC willcontinue to adjust its production capacity according to market demand. In termsof commercialization, SMC is in the process of setting up a sales team and isin contact with well-known companies at home and abroad to exchange ideas aboutcooperation.

In the future clinical trials and mRNA vaccines animal trials, SMCwill develop scientific and rigorous clinical trial protocols, continuouslyimprove the investigator's manual according to the epidemic and the researchprocess, improve quality research, strengthen the quality control of clinicalresearch samples, and report the progress of clinical research phases to thenational drug review department in a timely manner. The company will furtherimprove the process products, enhance process stability and conduct systematicand complete validation of the production process during the clinical trial.

The mRNA vaccine works by delivering andexpressing mRNA encoding antigens through dendritic cells, which then presentthe antigens and generate neutralizing antibody responses. mRNA vaccines aredegraded after intracellular expression of the target antigens, thus minimizingthe potential risk of insertion-induced mutations. mRNA vaccines producepotent, antiviral neutralizing immunoglobulins through only one or two low-doseimmunizations. Anti-viral neutralizing immunoglobulins induce humoral andcellular immunity with good protective effect. Compared to conventionalmethods, mRNA production facilitates large-scale production of sufficient dosesof vaccines needed to treat large populations. It offers multiple advantages interms of safety, cost-effectiveness, and induction of cellular and antibody-mediatedimmune responses.