As the ribonucleic acid (mRNA) candidate for the K-vaccine injection strategy of 2.2 trillion won is still being tested for immunogenicity in the laboratory, distrust is raised about the “application for emergency use approval in the first half of next year” that was announced in April. done.
President Moon Jae-in announced to the Global Vaccine Hub Promotion Committee that was launched on the 5th, “Please be prepared to develop an mRNA vaccine and see the end.” ST Pharm, which is in charge of clinical development of ', is currently conducting an immunogenicity test to confirm that it is possible to prevent corona infection in a laboratory to discover candidate substances, and did not disclose element technology information.
On June 8, Professor Hyuk-jin Lee of Ewha University (College of Pharmacy), an advisory member of the government’s expert committee on domestic mRNA vaccine development, said, “MRNA mass production technology, lipid nanoparticle (LNP) formulation (wrapping technology), human input technology, and material’s own element technology are stable. It is impossible to make mRNA without any one of commercialization technology and element technology, such as such.
ST Pharm, a clinical developer of candidate substances, replaced it with the introduction of LNP (lipid nanoparticle) drug delivery technology for the development and commercialization of a coronavirus vaccine from Genevant Science, Switzerland, on April 8.
ST Pharm, who participated in President Moon's vaccine strategy meeting, applied for a domestic patent for one LNP drug delivery system technology before its introduction in Switzerland. .
K-Vaccine's 'K-mRNA Consortium' (Korea Innovative Medicine Consortium, KIMCo) CEO Heo Kyung-wha told Newsis on the 19th of last month, "We plan to enter phase 1 clinical trial of vaccine candidate 'STP-2104'. The first stage goal is to obtain emergency use approval next year (phase 3 conditional permission) and produce 100 million doses that can be vaccinated to all citizens,” he said.
Regarding the consortium of three companies, CEO Huh said, “Three strong companies in each field of raw material, manufacturing, and new drug development will form a team to commercialize the mRNA COVID-19 vaccine by next year and build a mass production system of over 1 billion doses by 2023.” Building a development platform for the prototype virus is our priority,” so they demanded government support.
On the basis of the government's large amount of support, he set the vaccine development cost of existing vaccine manufacturers as equal to the investment cost of laboratory companies, and said, "We provided 12 trillion won to Pfizer and Moderna vaccines for the 20 trillion won emergency development cost of the US coronavirus vaccine. Full support from the government is essential. · Government support is needed in areas such as facility investment, clinical development, and licensing, he said.
In an interview at the time of introduction of the delivery system technology in Switzerland on April 9, SST Pharm CEO Kim Kyung-jin said, "As Moderna took 9 to 10 months to develop the corona virus, we expected that it would take a similar period to develop a vaccine," Business Post reported. did.
Regarding the K-Vaccine consortium, CEO Huh divided it into raw materials, manufacturing, and new drug development, and Hanmi Pharmaceutical plans to immediately supply linearized plasmid DNA (pDNA), a quality raw material suitable for mRNA vaccine production, and ST Pharm is pursuing emergency use approval for clinical trials. Production of lipid coating undiluted solution, GC Green Cross announced that it was in charge of filling and packaging of the undiluted solution.
Regarding the formulation of lipid nanoparticles (LNP), which is the core of mRNA vaccines, Professor Lee said in the previous interview, “mRNA has a large molecular weight and cannot enter the cell. It showed a difference from the K-Vaccine Consortium, saying, “Moderna has element technology and LNP technology depends on Arbutus of the United States.”
Professor Lee said, “There is a lot of need for element technology,” and “depending on how each of the five elements of the basic structure (5'CAP-5'UTR-ORF-3'UTR-PolyAtail) constituting the mRNA material is optimized, the antigen (virus) ) expression and mRNA stability.”
Professor Lee, who is a disciple of MIT professor Robert Langer, the founder of Moderna, said in an interview earlier, "Without one of commercialization technology and element technology, mRNA cannot be made."
Celltrion, which had surged in share price by preempting the subsidy as a supplier for the treatment of COVID-19 in the pharmacy, announced on the 4th that it had signed a contract with Trilink, a US mRNA platform-based drug contract development and manufacturing (CDMO) company.
Trilink possesses '5 prime capping' technology, a technology for producing mRNA raw materials, and Celltrion, a domestic technology introduction contractor, is eligible for state support as a candidate material supplier in the development of Moderna mRNA vaccine.