“STgen Bio’s entry into the global market and a growth to become a global contract development and manufacturing organization (CMDO) will play a significant role for Dong-A Socio Group to become a global healthcare player by 2025.”
STgen Bio CEO Choi Kyung-eun said this and other remarks at a recent interview with Korea Biomedical Review.
STgen Bio is a joint venture established in 2015 between Dong-A Socio Holdings and Meiji Seika Pharma. Last year, Dong-A Socio Holdings acquired STgen Bio as a subsidiary. In March, the company's name changed from DM Bio to STgen Bio.
With the streamlined governance, STgen Bio could pursue mid-to-long-term growth strategies quickly and flexibly, the company said.
According to Choi, STgen Bio plays a significant role within Dong-A Socio Group in discovering and nurturing new growth engines in the biopharmaceutical sector, along with Dong-A ST and ST Pharm.
“Last year, in Songdo, where STgen Bio is located, Dong-A ST’s biotech research institute and Dong-A ST’s pharmaceutical production site have been completed,” Choi said. “By building a biotech cluster within Dong-A Socio Group, we can simultaneously generate synergy effects to run R&D and manufacturing."
STgen Bio plans to actively develop DMB-3115, a biosimilar of Stelara (ustekinumab), which the group pushes for aggressively. STgen Bio handles manufacturing samples for clinical trials of DMB-3115, jointly developed by Dong-A ST and Meiji Seika. After a phase 3 study, STgen Bio plans to produce the drug for commercial use.
The company said DMB-3115 could be released after the original drug Stelara’s patent expires in September 2023 in the U.S. and July 2024 in Europe.
STgen Bio also manufactures DA-3880 (ingredient: darbepoetin alfa), a biosimilar of Aranesp developed by Dong-A ST, and supplies it to Japan. Aranesp is an anemia treatment developed by Amgen.
The company also manufactures and supplies Alteogen’s ALT-L9, a biosimilar of Eylea.
STgen Bio readies CDMO biz for cell/gene therapy
This year, STgen Bio has three goals – to prepare for inspections by the U.S. FDA and the EMA scheduled for 2023, expand manufacturing capacity with facility expansion, and broaden its business portfolio by establishing a platform for CDMO business.
“By receiving inspections by global regulatory agencies such as the FDA and EMA, we will secure a track record for commercialization of DMB-3115,” Choi said.
STgen Bio plans to construct a second plant. According to Choi, the existing plant is capable of producing 8,000 liters of drugs.
Out of 220 employees at STgen Bio, 80 percent are manufacturing workers.
To enter the CDMO market, the company plans to form a technology strategy team and collaborate with contract research organizations (CROs), contract development organizations (CDOs), and Dong-A ST Biotech Research Institute, Choi said.
Last year, STgen Bio signed an agreement with Protium Science to start the CDMO business.
Protium Science specializes in CDO business as a subsidiary of TiumBio, a local rare disease drug developer.
According to Choi, STgen Bio plans to enter the CDMO market in partnership with Protium Science to build an all-cycle, integrated system from R&D to production.
Such integrated CDMO service will help Korean bio venture firms develop and produce their pipelines swiftly to strengthen their business capabilities and create more opportunities.
STgen Bio is particularly interested in CDMO services for cell and gene therapy (CGT).
According to Choi, the company focuses on manufacturing monoclonal and recombinant protein-based biopharmaceuticals.
“In the short term, we will manufacture antibody-based next-generation dual antibodies and antibody-drug conjugates (ADCs). We will expand our business portfolio in the long term by manufacturing advanced modality drugs such as CGT,” she said.