Daewoong Bio expands into biopharmaceutical CMO business

Daewoong Bio is ramping up its efforts to enter the contract manufacturing organization (CMO) bunsiness.

The company announced on Wednesday that it will finish the construction of its biopharmaceutical plant in Hyangnam, Gyeonggi Province, in August and will use the plant to enhance its microbial-based biopharmaceutical CMO capabilities. The company had started constructing the plant in March of last year.

According to Daewoong Bio, its plant is designed to prevent cross-contamination through unidirectional flow.

The company explained that the new plant will feature an automated system from raw material intake to product shipment, enhancing cost competitiveness and quality.

Also, the plant will implement a manufacturing control system (MCS) to maximize efficiency and accuracy in production, as well as independent production lines for various formulations such as liquid vials, lyophilized products, cartridges, and spray solutions.

Once completed, the company aims to secure good manufacturing practice (GMP) approval from the Ministry of Food and Drug Safety (MFDS) by 2027 and approval from the U.S. FDA by 2028.

The facility will also take over the production of biopharmaceuticals currently manufactured by Daewoong Pharmaceutical and its affiliates, reinforcing its growth trajectory.

This move marks Daewoong Bio’s expansion from its traditional active pharmaceutical ingredients (API) manufacturing to biopharmaceutical production, with an eye on global market penetration.

Notably, the company stressed that it is targeting the growing market for microbial-based recombinant biopharmaceuticals.

According to the Domestic Biopharmaceutical Industry Key Data 2024 report by the Korea Biomedicine Industry Association (KoBIA), the Korean biopharmaceutical market grew by 14.9 percent over the past decade, reaching 5.2 trillion won ($3.7 billion) in 2022. Biopharmaceuticals now constitute 17.3 percent of the overall pharmaceutical market, with vaccines (45 percent), recombinant drugs (31.7 percent), and blood products (8.7 percent) leading the segment.

“Daewoong Bio is committed to evolving from a traditional API manufacturer to a biopharmaceutical company,” Daewoong Bio's Bio Plant Head Lee Ho-jin said. “Leveraging our capabilities in microbial-based recombinant drug production, we aim to penetrate the global CMO market and contribute to achieving 1 trillion won in sales by 2030.”