[K Manufacturing Industry, On Site] The 'Vaccine Production Hub' Is Hungry... Samsung Biologics Ventures into mRNA Raw Materials

Growing Presence of 'K-Bio'
Five Companies Including SK Bioscience Develop Vaccines Directly

Samsung Biologics Plant 3 (Photo by Samsung Biologics)

"COVID-19 has driven unprecedented rapid collaboration and innovation in the bio industry. Through the process of realizing innovation, we have been able to accelerate growth, find new opportunities, and achieve business expansion."

John Rim, CEO of Samsung Biologics, emphasized this in his opening remarks at the global bio event ‘BIO Digital 2021.’ Since his appointment at the end of last year, CEO Rim has declared a leap toward becoming a global comprehensive bio company. Over the past six months, Samsung Biologics has been expanding its business scope, including engaging in ‘end-to-end’ production from raw materials to packaging of messenger RNA (mRNA) vaccines, which have rapidly emerged due to COVID-19. COVID-19 has become both a crisis and an opportunity for ‘K-Bio.’

Last month, Samsung Biologics strengthened Korea’s position as a ‘global vaccine production hub’ by signing a contract with Moderna in the U.S. for COVID-19 vaccine contract manufacturing (CMO). This is the first case where a domestic company is responsible for the finished production of an mRNA vaccine. Starting in August, Samsung Biologics will begin full-scale production of the Moderna vaccine and supply hundreds of millions of doses worldwide, excluding the U.S. Industry experts evaluate that the contract was driven by Samsung Biologics’ production capacity, which is the largest in the world with a total of 364,000 liters. By the end of next year, the partially operational 4th plant, with a capacity of 256,000 liters that began construction last year, will also come online.

Samsung Biologics has also entered the raw material market for mRNA vaccines. It is expanding production facilities for mRNA vaccine active pharmaceutical ingredients. Until early this year, Samsung Biologics played a forward base role in producing antibody therapeutics for COVID-19 under contract for GSK and Eli Lilly, but it is now increasing its presence in the vaccine field as well. CEO John Rim stated, "As a leader in contract manufacturing, we will transform into a true ‘end-to-end’ solution provider company, from contract development to bio-safety testing, aseptic filling, and finishing processes."

There are also companies directly involved in COVID-19 vaccine development. According to the Ministry of Food and Drug Safety, five domestic companies have currently received approval for clinical trials of COVID-19 vaccines: SK Bioscience, Cellid, Genexine, YUBIOLOGICS, and GeneOne Life Science. All are conducting Phase 1 to 2 clinical trials, with some expected to enter Phase 3 in the second half of the year. Although they lagged slightly in the speed race, they aim to establish the presence of ‘K-Vaccine’ next year by emphasizing variant response capabilities and safety.

SK Bioscience is expected to enter Phase 3 next month. SK Bioscience is currently developing two COVID-19 vaccines: ‘NBP2001’ (Phase 1) and ‘GBP510’ (Phases 1 and 2). They plan to complete clinical trials for both candidates this month and select the one with superior data to proceed to Phase 3 in July. NBP2001 has received support through a national project by the Korea Disease Control and Prevention Agency, while GBP510 is being developed with support from the Bill & Melinda Gates Foundation (BMGF) and the Coalition for Epidemic Preparedness Innovations (CEPI). GBP510 recently received an additional $173.4 million (approximately 190 billion KRW) in funding from CEPI.

Cellid, which is conducting Phase 1 and 2a clinical trials for the candidate ‘AdCLD-CoV19,’ is also expected to enter Phase 3 in the third quarter. Previously, Cellid announced that all 30 participants in the Phase 1 trial developed neutralizing antibodies. Genexine, which switched its candidate to ‘GX-19N’ to enhance variant response, achieved a milestone by signing a contract to supply 10 million doses to Indonesia in April. This pre-sale was made while Phase 2a clinical trials are ongoing domestically.

Additionally, YUBIOLOGICS will begin Phase 2 clinical trials for its COVID-19 vaccine candidate ‘Yukobac-19’ at the end of this month. It plans to enter Phase 3 in the second half of the year and, based on interim results, apply for approval as early as the end of the year. GeneOne Life Science has completed the second dosing of Phase 1 clinical trials for ‘GLS-5310’ and plans to announce clinical results around next month.

This content was produced with the assistance of AI translation services.