The global competition in messenger RNA (mRNA) platform development has entered a critical phase. Major pharmaceutical companies are investing heavily in new indications for vaccines targeting influenza and cancer, achieving visible results. In South Korea, the government and biotech firms are collaborating to initiate domestic production efforts.
According to industry sources, amid competition surrounding next-generation platforms such as antibody-drug conjugates (ADCs), bispecific antibodies, and cell therapies, mRNA cancer vaccines have emerged as a new battleground, demonstrating the potential for personalized treatment. Recently, a personalized mRNA cancer vaccine jointly developed by U.S. pharmaceutical companies Moderna and Merck (MSD) showed positive results in a Phase 3 trial for melanoma, positioning it as a 'game changer.'
The competition among big pharmaceutical companies utilizing mRNA technology is expected to intensify. German biotech firm BioNTech signed a deal last year to acquire its competitor CureVac for $1.25 billion in an all-stock transaction, focusing on expanding its mRNA cancer pipeline. This acquisition aims to strengthen research, manufacturing, and commercialization of mRNA-based cancer immunotherapies.
Sanofi invested $3.2 billion in 2021 to acquire the mRNA venture Translate Bio, aiming to develop new mRNA vaccines for influenza and other diseases. Pfizer and BioNTech are also advancing their mRNA influenza vaccine into Phase 3 trials, closely following Moderna. In August, Moderna received FDA approval for its mRNA influenza vaccine, 'EmplusiVa,' marking the first mRNA-based flu vaccine to gain regulatory approval in the U.S. GSK recently announced Phase 2 results for its mRNA seasonal flu vaccine candidate and plans to enter Phase 3 trials.
An industry insider noted, "The fact that mRNA technology has moved beyond COVID-19 to the seasonal flu market signifies its commercialization stage. If GSK proves competitive in Phase 3 trials, the competition between traditional technologies and mRNA platforms in the flu vaccine market will intensify further."
The South Korean government's push for domestic mRNA production is gaining momentum. The Korea Disease Control and Prevention Agency has increased its budget for the 'Pandemic Preparedness mRNA Vaccine Development Support Project' to 40.5 billion won ($30 million) for next year, a 53.4% increase from this year's budget of 26.4 billion won. The government previously announced plans to invest a total of 505.2 billion won by 2028 to localize currently imported mRNA vaccines and secure rapid development platforms. The goal is to support development from preclinical to Phase 3 trials, aiming for product approval by 2028.
GC Pharma is a leading candidate for domestic production. The company submitted an Investigational New Drug (IND) application for its COVID-19 mRNA vaccine candidate last month and plans to enter Phase 2 trials this fall. GC Pharma stated, "We aim to establish a proprietary mRNA-lipid nanoparticle (LNP) platform that can be used broadly, not limited to specific vaccine development, and create a structure that allows us to expand our business into contract development and manufacturing (CDMO) beyond mere technological independence."
In addition to vaccine developers, movements toward localization are also evident in the CDMO sector. ST Pharm has announced its transition to an 'integrated RNA CDMO' by expanding its existing oligonucleotide CDMO business into mRNA and LNP formulation.
Jeong I-soo, a researcher at IBK Investment & Securities, commented, "As global latecomers accelerate their mRNA cancer vaccine development, the demand for CDMO services for early clinical volumes is expected to rise, increasing market interest in domestic companies with mRNA delivery and platform technologies."
* This article has been translated by AI.
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