"We aim to obtain US GMP certification by 2028 through our own products and achieve annual sales of 1 trillion KRW to become one of the top 10 pharmaceutical companies in Korea."
Pen Do-gyu, Head of Production at Daewoong Bio, recently met at Daewoong Bio headquarters in Gangnam-gu, Seoul, and stated, "We will complete all facilities at the Hyangnam Bio Plant within this year and start operations," adding, "Although we started with active pharmaceutical ingredients (APIs), we have transformed into a pharmaceutical company encompassing finished products and biopharmaceuticals, and we aim to create a growth trajectory."
Daewoong Bio, established in 1983 as part of the Daewoong Group, began with APIs and has recently expanded into finished pharmaceutical production. With the construction of a new plant, it is further expanding its business scope to include biopharmaceutical contract development and manufacturing organization (CDMO) services. The core of this expansion is the Hyangnam Bio Plant in Hwaseong-si, Gyeonggi-do, which was completed earlier this month. The plant is equipped with various state-of-the-art production equipment, focusing on microbial-based recombinant gene medicines as its main products.
To ensure quality assurance, a unidirectional flow system was introduced to prevent cross-contamination of medicines by other pharmaceuticals. The entire process from culturing, purification, to finished product manufacturing is sequentially conducted. Regarding finished product manufacturing, the plant has a diverse lineup including liquid vials, lyophilized products, prefilled syringes (PFS), and topical solutions. Daewoong Bio plans to participate in the international pharmaceutical and bio exhibition (CPhI) held in Italy early next month, focusing on promoting the Hyangnam Bio Plant.
Pen, the head of the division, explained, "The plant was designed and built with the US market as the initial target," adding, "We aim to meet Korea’s Good Manufacturing Practice (GMP) standards by 2027 and obtain the US Food and Drug Administration (FDA) current Good Manufacturing Practice (cGMP) certification the following year." To obtain cGMP certification, it is necessary to produce products actually sold in the US. However, companies without experience producing such products often face a vicious cycle where securing US-approved product orders becomes difficult. Daewoong Bio plans to overcome this by leveraging Novosis, a bone substitute medical device from its group affiliate CJ Bio. Pen said, "We are looking at bone morphogenetic protein (BMP-2) used in Novosis as a product for the US market," and explained, "Our goal is to produce this and obtain cGMP certification." Novosis has recently signed technology export contracts and continues to explore entry into the US market.
Recently completed Daewoong Bio Hyangnam Bio New Factory in Hwaseong-si, Gyeonggi-do [Photo by Daewoong Bio]
The Hyangnam Plant was built specializing in microbial medicines rather than antibody drugs or animal cell-based medicines, which occupy the largest share in the existing bio CDMO market. Pen emphasized, "Although microbial medicines account for less than 20% of the total share, they have an annual growth rate of about 7-8%, showing sufficient potential," adding, "Since Novosis and EGF, which we have produced, are all microbial-based, we plan to specialize and leverage our strengths in this area." Furthermore, by 2027, Daewoong Bio plans to establish its own formulation research institute to develop specialized production technologies and enhance CDMO competitiveness.
Another growth engine aimed at achieving annual sales of 1 trillion KRW by 2028 is the new cephalosporin antibiotic plant scheduled for completion near the new bio plant in May next year. Cephalosporins are a class of antibiotics that, despite concerns about antibiotic misuse and resistance leading to reduced prescriptions, are still widely used for patients with respiratory or gastrointestinal infections. Pen explained, "Although there are concerns about market growth due to the lack of new antibiotic drugs, it remains a market growing globally at about 3% annually," adding, "With no newly built or remodeled domestic plants for over ten years, we plan to target the market with better quality and productivity through a new plant equipped with the latest equipment."
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