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BMI-2004 is a novel recombinant ovine hyaluronidase developed by BMI Korea Co., Ltd. It functions as a hyaluronic acid modulator by enzymatically degrading hyaluronic acid in the extracellular matrix, which temporarily increases the permeability of subcutaneous tissue. This mechanism is primarily intended to facilitate the transition of large-volume biologics, such as monoclonal antibodies, from intravenous (IV) to subcutaneous (SC) administration. BMI-2004 utilizes a proprietary liquid formulation technology that ensures enzyme stability at a pH of 5, which is compatible with the preferred pH for most monoclonal antibody formulations. The drug is currently in Phase 1 clinical development, where it is being evaluated for safety, tolerability, and allergic potential in healthy adults.
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