Q. Please introduce STgen Bio.

A. STgen Bio, formerly known as DM Bio, was initially established as a joint venture CMO between Korea’s Dong-A Socio Holdings and Japan’s Meiji Seika Pharma. In September 2021, the company centralized its governance structure and operations under Dong-A Socio Holdings, and rebranded as STgen Bio.

The name “STgen Bio” is derived from the combination of ‘Science Technology’ and ‘Gene’, symbolizing the company’s strong commitment to establishing a clear identity and direction of future strategies and businesses.

As a leading biopharmaceutical company, STgen Bio provides CMO services for mammalian cell-based drug substances and drug products including antibodies, recombinant proteins, and vaccines. STgen Bio has horizontally expanded its services by partnering with CDO to offer clients a one-stop CDMO platform. Through this collaboration, we offer a comprehensive range of services from process development, technology transfer, manufacturing, analysis, and regulatory support.

Q. Could you please introduce the production facilities and technology.

A. STgen Bio produces high-quality biopharmaceuticals through its state-of-the-art production facility located in Songdo. STgen Bio's total DS production facility of 9000L consists of production lines of various sizes such as 500L, 1000L, and 2500L, and it can respond flexibly from preclinical to commercial production to meet the needs of customers. In addition, hybrid design using a mixture of single-use and multi-use systems can minimize cross-contamination and produce high-quality medicines stably. DP has a PFS charging line and can charge 10,800 syringes per hour. In addition, the entire process from syringe labeling to blister/carton packaging and barcode printing has automated secondary packaging facilities, increasing the efficiency in production. These production facilities and technology are playing an important role in STgen Bio's competitiveness in the global market. In addition, STgen Bio is responding to the needs of the global market through continuous research and development and quality management, and is striving to meet the diverse needs of customers.

Q. We would like to know the key vision and goals of STgen Bio moving forward.

A. STgen Bio's vision is to strengthen its position as a global CMO and contribute to the expansion of K-Bio's global market.

Notably, within just four years of its establishment, STgen Bio has achieved a significant milestone by successfully passing the Japanese PMDA GMP conformity inspection. This accomplishment has allowed us to market our biopharmaceutical products in Japan. Additionally, in line with the development timeline of DMB-3115 (Stelara biosimilar), a collaborative project between Dong-A ST and Meiji Seiki Pharma, we, as the manufacturer, are preparing for GMP inspections by the regulatory authorities in the United States (FDA) and Europe (EMA) within this year. We have undertaken the enhancement of our manufacturing and quality management systems based on cGMP standards.

Drawing upon our experience and expertise gained through biopharmaceutical manufacturing and global expansion, STgen Bio aims to establish robust manufacturing and quality management systems that can swiftly adapt to global regulatory changes. Through collaborations with renowned domestic biopharmaceutical ventures and companies, we strive to contribute to the expansion of the Korean global biopharmaceutical market.

In line with our mission, STgen Bio plans to expand its business scope to include the production of next-generation modalities, such as bispecific antibodies, antibody-drug conjugates (ADCs), and cell and gene therapies.