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Daewoong Group to Spearhead Domestic Production of Hyperlipidemia Treatments

by Amy

Daewoong Group announced on Thursday that three of its subsidiaries will spearhead a government initiative aimed at increasing the local production of raw materials for hyperlipidemia treatments. This move comes in response to the rising number of patients affected by the condition in South Korea.

The subsidiaries involved—Daewoong Pharmaceutical, Daewoong Bio, and Daewoong Therapeutics—have been designated as key organizers for the 2024 Material and Parts Technology Development Project. This project, which will last over four years, is backed by the Ministry of Trade, Industry and Energy.

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Currently, South Korea’s self-sufficiency in raw materials for hyperlipidemia medications stands at just 13%, with a significant 87% imported from abroad. This heavy reliance on foreign sources poses risks to the supply chain, especially during global disruptions like those seen during the pandemic.

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The project’s goal is to localize the production of third-generation statin-based drugs, such as pitavastatin, and to develop the technologies needed for manufacturing both intermediate and finished products domestically. The initiative will span 54 months, concluding in December 2028, and will receive approximately 18 billion won (about $13.5 million) in research and development funding from the government.

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Daewoong Group plans to identify essential starting materials and develop processes for creating intermediate compounds and finished drugs. To ensure effective manufacturing, the company will implement systems for managing purity, flexible substance management, and process evaluations. They also aim to produce finished drugs that comply with Good Manufacturing Practice standards.

Most raw materials for hyperlipidemia drugs currently produced in Korea utilize a “batch process,” where each step is conducted separately. In contrast, Daewoong’s proposed “continuous process” allows for a constant flow of raw materials, which enhances quality control. This method is expected to improve production efficiency, reduce manufacturing time, and lower costs by around 30%.

“Daewoong Group is dedicated to improving quality management and manufacturing capabilities,” said Park Seong-soo, CEO of Daewoong Pharmaceutical. “Through this domestic project, we aim to create a successful model for integrating localization from raw materials to finished products. This will enhance our self-sufficiency rate and boost the global competitiveness of domestic pharmaceuticals.”

Additionally, Daewoong will establish a comprehensive database for each production process, develop automation software and equipment, and evaluate the performance of their continuous production methods alongside the raw materials generated through this system.

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