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ArborMed Co., Ltd. (Co-CEOs: Kyojin Park and Weonbin Lim), focused on the development of therapies for rare and intractable diseases, announced on the 5th that it has entered into a licensing-out agreement with Belgium-based pharmaceutical company Hyloris Pharmaceuticals SA for the European rights to its rare disease drug candidate, ARBM-101.

The agreement covers multiple indications, including Wilson disease, iron overload disorders (including hereditary hemochromatosis), and primary biliary cholangitis (PBC), all of which are rare and difficult-to-treat hepatic and metabolic diseases. The total deal value, including milestone payments, amounts to up to approximately KRW 2.3 trillion (USD 160 million).

ArborMed noted that successfully completing a European licensing-out agreement at the clinical entry stage demonstrates that its overseas partner highly values the innovation and commercial potential of ARBM-101.

Hyloris is a publicly listed Belgian pharmaceutical company with capabilities spanning clinical development, regulatory approval, pricing and reimbursement negotiations, and commercialization across Europe. ArborMed stated, “Hyloris possesses strong pipeline management capabilities and deep expertise in product development and commercial strategy, including product positioning, launch planning, and partner execution support. It is an optimal partner to accelerate early entry into the European market.”

Co-CEO Kyojin Park commented, “This agreement goes beyond merely completing European partnering; it represents a meaningful validation of the potential of ARBM-101. Following its selection in 2023 for research support under the Korea Drug Development Fund (KDDF) and the acquisition of FDA Orphan Drug Designation (ODD) in 2024, we plan to design a development and regulatory strategy in Europe leveraging fast-track pathways such as Conditional Marketing Authorization (CMA) from the EMA. At the same time, we will actively pursue additional partnering opportunities in the United States, Japan, and other markets.”

The Korea Drug Development Fund is a pan-government national R&D program designed to strengthen the global competitiveness of the domestic pharmaceutical and biotech industry and secure pharmaceutical sovereignty by supporting the full lifecycle of drug development. With support from KDDF, ArborMed has completed final validation of ARBM-101 through additional mechanism-of-action studies, animal efficacy studies, and preliminary toxicology studies for its copper-specific low-molecular-weight peptide.

Stijn Van Rompay, CEO of Hyloris, stated, “We bring extensive experience across clinical development, competitive positioning, and market entry toward commercialization. Through a joint committee with ArborMed, we will further strengthen the execution of early market entry strategies in Europe.”

ArborMed is a biopharmaceutical company dedicated to developing innovative therapies for rare and intractable diseases, aiming for rapid development, approval, and commercialization based on strong scientific evidence and clinical execution capabilities. In addition to ARBM-101, the company is developing a pipeline of therapeutic candidates targeting multiple indications, including congenital hearing loss and acute respiratory distress syndrome (ARDS).

Co-CEO Kyojin Park added, “With this agreement, we have completed the technology transfer of ARBM-101 in the European region. Building on this milestone, we aim to secure additional licensing agreements and achieve our goals of Pre-IPO financing in 2026 and a KOSDAQ listing in 2027.”