Joint Research with Kookmin University and Dongguk University… Aiming to Enter Phase 1 Clinical Trials by 2030
 
MFC, a company specializing in active pharmaceutical ingredients (APIs) led by CEO Hwang Seong-gwan (Department of Chemistry, Class of ’85), an alumnus of our university, has been selected as the lead research and development institution for a national project in the “Personalized Diagnostic and Therapeutic Products” category under the Bio-Industry Technology Development Program administered by the Ministry of Trade, Industry and Energy.
 
With a total project budget of approximately 7.1 billion won (including 4.8 billion won in government funding), MFC will lead the development of an AI-based oral insulin over a period of about 54 months, through December 2030. The project holds particular significance as it represents new drug development through industry-academia collaboration between an alumni-led company and Kookmin University, CEO Hwang’s alma mater, which is participating in the joint research.
 
This research aims to develop technology to shift insulin administration from the current injection-based method to an oral formulation. Insulin, being a protein, is easily broken down by digestive enzymes in the gastrointestinal tract and has an extremely low absorption rate through the intestinal mucosa, which has posed challenges for the development of oral medications. To overcome these limitations, MFC proposed a new approach that combines AI-based formulation design with continuous manufacturing process technology.
 
In this research, Kookmin University is contributing to the design of an optimal, customized oral formulation for pediatric diabetes by applying stabilization technology to prevent the breakdown of insulin in the gastrointestinal tract and absorption-enhancing technology to improve intestinal permeability. The Dongguk University Industry-Academic Cooperation Foundation is also participating as a joint R&D partner and plans to conduct nonclinical pharmacokinetic (PK) and bioavailability studies, as well as efficacy verification research.
 
MFC plans to complete nonclinical efficacy and safety evaluations of the oral insulin finished drug product by 2030 and lay the groundwork for entering Phase 1 clinical trials, as well as for global regulatory approval and technology transfer. Furthermore, the company intends to explore new business opportunities by expanding the oral peptide drug delivery platform secured through this project to various protein-based pharmaceuticals.
 
CEO Hwang Seong-gwan stated that being selected for this government-funded project is highly significant as it recognizes the company’s technological capabilities in active pharmaceutical ingredients (APIs) and the innovation of its AI-based manufacturing technology. He also expressed his ambition to successfully develop oral insulin—which will enhance patient convenience—and thereby continue the company’s leap toward global technology transfer and its transformation into a next-generation digital pharmaceutical platform company.
 
As this project involves collaboration between a company led by a Kookmin University alumnus and researchers from his alma mater under the common goal of new drug development, it is expected to serve as a meaningful example of industry-academia cooperation between the university and its alumni-led companies.