Graphic=Son Min-gyun

SK pharmteco, a contract development and manufacturing organization (CDMO) subsidiary of SK Group, has begun producing clinical active pharmaceutical ingredients (APIs) for the development of Eli Lilly and Company's next-generation glucagon-like peptide-1 (GLP-1) obesity drug. The APIs will be used in research on a long-acting formulation that can be administered once a month.

According to the industry on the 10th, SK pharmteco began producing clinical trial APIs last month through its subsidiary SK biotek. The batch is for clinical trials, not for commercial use, and is expected to be used to develop a long-acting formulation that extends the dosing interval of the existing once-weekly injection to once a month.

The exact components of the substance have not been disclosed. However, the industry sees a high likelihood that it is Lilly's obesity drug "Mounjaro (tirzepatide)." Specific trial plans, including the countries or institutions where the clinical studies will be conducted, have not been revealed.

The day before, Lilly also signed a memorandum of understanding (MOU) with the Korean government to invest a total of $500 million (about 736.5 billion won) in Korea over the next five years. The company is expected to expand cooperation with domestic corporations across key research and development (R&D) areas going forward.

Previously, Lilly had pursued building an integrated production system in North Chungcheong Province that would cover pharmaceutical intermediates, APIs, and finished goods. Under the structure, SK would produce the core peptide raw materials for Mounjaro and supply them to the finished goods manufacturer.

The construction site of the new M5 (left) and M6 (right) plants at SK biotek in the Sejong Myeonghak Industrial Complex in November last year. The two buildings are connected./Courtesy of Reporter Yeom Hyun-ah

SK pharmteco is currently building SK biotek's large-scale peptide raw material production facilities, Plants 5 and 6 (M5·6), in the Sejong Myeonghak Industrial Complex. After completion in June, the goal is to begin full-scale operation by year's end.

The global obesity drug market is currently led by Wegovy and Mounjaro. Both products are once-weekly injections. Major pharmaceutical companies, including Denmark's Novo Nordisk, U.S. firms Pfizer and Amgen, and the United Kingdom's AstraZeneca, are actively developing long-acting formulations dosed about once a month to improve dosing convenience.

Lilly is also collaborating with domestic and overseas corporations to develop long-acting formulations.

With Peptron, a domestic drug delivery technology corporation, it signed a technology evaluation agreement in Oct. 2024 for the long-acting drug delivery platform "SmartDepot" and is conducting joint research.

In June last year, it signed a deal with Swedish pharmaceutical company Camurus to adopt the lipid-based drug delivery platform "FluidCrystal." It plans to apply the platform to incretin-based new drug candidates to develop a long-acting formulation that can be administered once a month.

Initially, Lilly planned to apply a drug delivery system (DDS) to the API produced by SK to make finished goods. For this clinical API, however, there is also a possibility that Lilly will forgo DDS and independently research a new formulation substance.

Novo Nordisk developed "Wegovy (semaglutide)," which extended the duration of action to once weekly by modifying part of the molecular structure and fatty acid chain of "Saxenda (liraglutide)," an obesity drug that previously required daily injections.

Meanwhile, the manufacturing of intermediates needed for raw material production is reportedly being handled by domestic corporation IT-CHEM. In Dec. last year, IT-CHEM disclosed that it had signed a contract worth about 10 billion won with SK biotek for contract manufacturing of pharmaceutical intermediates. The contract period runs from Feb. 2026 to May 2027.

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