Qualified for Sales at Home and Abroad
Moderna's COVID-19 vaccines produced by Samsung Biologics have obtained approval from the Korean Ministry of Food and Drug Safety. This means that the vaccines can be sold at home and abroad.
The approved product is Spikevax, which is administered in the form of an injection. It is the first domestically produced mRNA COVID-19 vaccine.
Moderna's vaccines produced by Samsung Biologics were supplied to Korea in October. At the time, a limited amount of the vaccine, 2.43 million doses, was delivered to hospitals under emergency use authorization before official product approval.
The vaccines produced by Samsung Biologics were also approved for emergency use in the Philippines on Nov. 26 and Colombia on Dec 2.
Samsung Biologics has recently signed a contract with Greenlight Bioscience of the United States for contract production of drug substances for COVID-19 mRNA vaccines. Thus far, Samsung Biologics has received drug substances from Moderna to produce the vaccines. But now, it can produce the vaccines using the substances it produces. This means it can provide end-to-end services related to contract manufacturing of mRNA vaccines, from raw material production to fill & finish manufacturing, labeling, and packaging.
Samsung Group is determined to expand its biotechnology business. Samsung Electronics vice chairman Lee Jae-yong laid out a 240 trillion won investment plan on Aug. 24, 11 days after his release on parole. The bio-industry was selected as a next-generation growth engine along with semiconductors and next-generation telecommunications.
Samsung Biologics’ market cap has reached 57.7 trillion won over the past 10 years since its foundation. It has three contract development and manufacturing organization (CDMO) plants. When its fourth plant is completed, its production capacity will rise to 620,000 liters, making it an unrivaled No. 1 player in the global CDMO market. The new plant will widen the capacity gap with Germany’s Beringer Ingelheim, whose capacity is expected to reach 480,000 liters in 2023.
During his visit to the U.S. from Nov. 14 to 24, Lee met with Nuba Apeyan, co-founder and chairman of Moderna’s board of directors before anyone else. He sought to strengthen ties with Moderna to enhance the stability of Samsung Biologics' CDMO business.