Stgenbio expands global footprint in biopharma CMO market

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Stgenbio expands global footprint in biopharma CMO market

Published: 30 Jun. 2025, 14:02

The Stgenbio offices [STGENBIO]

Stgenbio is strengthening its presence in the global biopharmaceutical Contract Manufacturing Organization (CMO) market, following a profitable turnaround and steady increase in sales last year.

The company is responsible for the production of Dong-A ST’s biosimilar Imuldosa, which has received regulatory approval in both the United States and Europe. Domestic sales of the drug are also climbing, with the company crediting its growth to a quality-focused CMO service platform.

Founded in 2015, Stgenbio has made continuous investments in high-end facilities and manufacturing technologies. That commitment bore fruit last year, when the company passed inspections by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on its first attempt — a major achievement for a Korean CMO.

The company has also secured Good Manufacturing Practice (GMP) certifications from eight additional countries, including Japan, Saudi Arabia and Turkey. Its production track record includes biosimilars such as Imuldosa and Darbepoetin alfa, a biosimilar of NESP, a drug used to treat anaemia, further demonstrating its capabilities in commercial-scale drug manufacturing.

To meet rising global demand, Stgenbio is now expanding its manufacturing capacity. It has recently acquired advanced aseptic filling equipment, including an isolator system that enables sterile production in a sealed environment. With this addition, the company expects to triple its annual output to 28 million pre-filled syringes (PFS).

“Increasing our PFS capacity more than threefold enables us to meet the diverse needs of global clients,” a company representative said. “In the mid-to-long term, we plan to construct a second facility to expand total production to four times current levels.”

The company also aims to secure future growth engines by investing in next-generation platform technologies, including cell and gene therapies.

Backed by international certifications and recent technological upgrades, Stgenbio is now seen as a growing player in the global CMO market.

BY JANG HAYOON [[email protected]]

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