STGenBio "Next Year, Leap to Global Company with Biosimilar 'DMB-3115'"

Interview with Choi Kyung-eun, CEO of STGenBio

Autoimmune Treatment Stelara Biosimilar
Phase 3 Clinical Trials Underway in 9 Countries Including the US
Global Market Size Reaches 9 Trillion Won
Intense Competition in Biosimilar Development

STGenBio's 7th Anniversary
Reborn as a Dong-A Socio Group Affiliate
License-Out Agreement with Multinational Intas
Plans to Accelerate Global Expansion

Choi Kyung-eun, CEO of STGen Bio

[Asia Economy Reporter Chunhee Lee] "Next year, through ‘DMB-3115,’ we aim to have Estigen Bio's quality level evaluated by advanced regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), establishing ourselves as a truly global biopharmaceutical manufacturing specialist."

Choi Kyung-eun, CEO of Estigen Bio, stated in an interview with Asia Economy on the 6th the significance of DMB-3115 as Estigen Bio's core pipeline going forward. DMB-3115 is a biosimilar (biopharmaceutical generic) of ‘Stelara,’ an autoimmune disease treatment jointly developed at the Dong-A Socio Group level. Currently, Phase 3 clinical trials are underway in the U.S. and nine European countries. Stelara is a blockbuster drug with a global market size of about 9 trillion KRW, but with its patent expiration approaching, fierce competition in biosimilar development is unfolding.

Taking a Bold Step in Biosimilars

Estigen Bio may be an unfamiliar name, but it celebrated its 7th anniversary on the 1st of this month. At its founding, it was established as DMBio, a joint venture (JV) between Dong-A Socio Group and Japan’s Meiji Seika Pharma. However, recently, Dong-A Socio Group acquired all shares, transforming it into a Dong-A Socio Group affiliate.

The name change to Estigen Bio marked a fresh start. ‘ST’ stands for Science Technology, a term frequently found in Dong-A Socio Group subsidiaries such as Dong-A ST and ST Pharm. CEO Choi explained, "Through the name change, we have solidified our identity as part of Dong-A Socio Group and declared the company’s future strategy and direction." By adding ‘gen’ for gene to the name, they expressed their intention to diversify business from producing mainly monoclonal antibodies and recombinant proteins to next-generation modality drugs such as cell and gene therapies (CGT).

Regarding the relationship with Meiji Seika Pharma, CEO Choi said, "We have a long history of cooperation," and added, "A comprehensive and strategic partnership will continue." DMB-3115 is not solely developed by Dong-A Socio Group but is a joint development with Meiji Seika Pharma. Furthermore, they have signed a global license-out agreement with multinational pharmaceutical company Intas to accelerate global expansion.

They also revealed plans to secure production of a wider variety of biosimilars beyond DMB-3115. Currently, Estigen Bio is cooperating on the production and supply of ALT-L9, a biosimilar of Alteogen’s age-related macular degeneration treatment ‘Eylea.’ Through this, "within the next 1 to 2 years, we will manufacture and supply two biosimilar products launched in the U.S. and European markets," and "we are also exploring investments in various next-generation biopharmaceuticals," they stated.

Flexible CDMO Operation

They are actively pursuing expansion into contract development and manufacturing organization (CDMO) beyond biosimilars. CEO Choi said, "We expanded into CDMO to diversify our business," and added, "Recently, as domestic bio-venture companies’ development items have diversified and visible achievements have increased, production requests for global clinical trials are rising."

However, in the bio CDMO industry, where economies of scale through mass production are a key driver of increased production capacity, Estigen Bio’s relatively small production scale is sometimes seen as a risk. This is because Estigen Bio’s production capacity remains at the 8,000-liter scale established at its founding.

Regarding this, CEO Choi emphasized that being small actually enables efficient and flexible production. He explained, "We have a hybrid system that combines the advantages of single-batch and multiple repeated production systems," and said, "When production scale is too large, it can be difficult to respond quickly to market changes, but Estigen Bio’s small-scale, independent production facilities are suitable for flexible operation." However, he added that they are also reviewing the possibility of increasing production capacity and establishing a second plant to expand overall business orders and attract new customers.

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