Kyungdong Pharmaceutical announced on the 11th that it has been selected for the project "Development of Formulation and Manufacturing Technology for Highly Stable Oral Antibody Drugs," part of the Bioindustry Technology Development Project led by the Ministry of Trade, Industry and Energy.
With this project selection, Kyungdong Pharmaceutical plans to embark on the world's first research and development of oral antibody drugs. Last month, it signed an agreement with the Korea Institute for Advancement of Technology to carry out the project. The project will receive a total of 4.5 billion KRW in government funding over 4 years and 7 months. Including institutional contributions, approximately 6 billion KRW will be invested.
In the first phase, Mokpo National University will lead the technology development until 2026. The goal is to secure core technology for an intestinal transporter-mediated oral absorption enhancement drug delivery system, clarify the mechanisms for improved oral absorption, and obtain non-clinical data.
In the second phase, Kyungdong Pharmaceutical aims to manufacture oral antibody finished drugs, demonstrate Good Manufacturing Practice (GMP) production, and apply for an Investigational New Drug (IND) approval by 2028. Daegu Catholic University and Dongguk University will participate as joint research institutions.
A Kyungdong Pharmaceutical representative stated, "There are no antibody drugs approved in oral formulations for the treatment of cancer or autoimmune diseases," adding, "Developing oral antibody drug formulations is a highly challenging technology, and success in development is expected to have a significant ripple effect."
They continued, "We will do our best to develop the world's first oral antibody drug formulation and manufacturing technology to secure differentiated product competitiveness, enhance patient convenience, and lead efforts to address unmet needs in medical practice."
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