Daewoong to lead homegrown hyperlipidemia therapy

Daewoong Group announced Thursday that three of its subsidiaries will participate in a government-led project aimed at localizing raw materials for hyperlipidemia treatments amid a growing number of patients suffering from the disease here.

Daewoong Pharmaceutical, Daewoong Bio and Daewoong Therapeutics were picked as primary organizers for the 2024 Material and Parts Technology Development Project, an over four year-long scheme initiated by the Ministry of Trade, Industry and Energy.

Currently, the country is 13 percent self-sufficient in raw material for hyperlipidemia medications, with 87 percent reliant on overseas imports. Such heavy dependency on foreign markets raises concern about the vulnerability of the supply chain in the event of global disruptions, such as those experienced during a pandemic.

The project's objective is to localize third-generation statin-based hyperlipidemia drugs, including pitavastatin, and develop the necessary technologies for producing both intermediate and finished drugs within Korea. Spanning 54 months from this year until December 2028, the initiative will receive a total of 18 billion won ($13.5 million) in R&D support from the government.

Daewoong Group intends to identify key starting materials, develop intermediate and synthetic processes, and secure the technology required for manufacturing finished drugs.

To establish an effective manufacturing process for finished drugs, Daewoong plans to implement systems for purity management, flexible substance management and process evaluations, along with demonstrating the production of finished drugs under Good Manufacturing Practice standards.

According to the group, most raw materials for hyperlipidemia drugs produced in Korea are currently manufactured using a "batch process" method, which operates each process separately. In contrast, Daewoong's "continuous process" ensures consistent quality by allowing raw materials to be input in a constant flow, thereby enhancing overall raw material quality. The approach promises significant improvements in production efficiency, a reduction in production time, and an approximate 30 percent decrease in manufacturing costs, according to the company.

"Daewoong Group has been committed to enhancing quality management and manufacturing capabilities," Daewoong Pharmaceutical CEO Park Seong-soo said. "Through the domestic project, we aim to establish a successful model for the vertical integration of localization from raw materials to finished products, thereby contributing to the improvement of the self-sufficiency rate and the global competitiveness of domestic raw materials and finished drugs."

Daewoong will also establish a database for each process, develop automation software and equipment, and evaluate the performance of the continuous process along with the raw materials produced through it.