Huonslab Patents Subcutaneous ADC Formulation Using HyDIFFUZE Platform, Demonstrating 126% Increase in Systemic Drug Exposure
核心洞察
Huonslab (搜索) has secured a patent for a subcutaneous ADC formulation using its proprietary hyaluronidase-based HyDIFFUZE (搜索) platform, potentially replacing IV infusion for antibody-drug conjugates.
In nonclinical pharmacokinetic studies, the HyDIFFUZE (搜索)-enabled formulation increased systemic drug exposure (AUC) by up to 126% and peak plasma concentration (Cmax) by up to 149%.
The platform demonstrated excellent physicochemical stability at high concentrations and faster plasma concentration increases following subcutaneous administration.
Gyeonggi-based pharmaceutical firm Huonslab (搜索), the R&D subsidiary of Huons Group, has secured a patent covering a subcutaneous formulation for antibody-drug conjugates (ADCs) incorporating its proprietary human-derived hyaluronidase-based platform technology, HyDIFFUZE (搜索), the company announced Monday.
The patent represents a significant step toward replacing intravenous infusion—the current standard for all approved ADCs—with a more convenient subcutaneous injection. ADCs are targeted cancer therapies that pair a monoclonal antibody with a cytotoxic drug payload to attack specific cells such as cancer cells. The global ADC market has been expanding rapidly across diverse indications, yet all currently approved ADCs are administered via IV infusion, creating demand for subcutaneous alternatives that improve patient convenience and healthcare efficiency.
Platform Mechanism and Pharmacokinetic Performance
The HyDIFFUZE (搜索) platform works by breaking down hyaluronic acid in the skin and underlying tissue, thereby speeding absorption and improving how ADC drugs spread through the body. Because ADCs are structurally complex biologics, developing subcutaneous formulations requires advanced technologies capable of simultaneously ensuring stability at high concentrations and efficient subcutaneous drug delivery.
In nonclinical pharmacokinetic evaluations, the HyDIFFUZE (搜索)-enabled ADC subcutaneous formulations demonstrated compelling results. Compared to formulations without HyDIFFUZE, systemic drug exposure measured by AUC increased by up to 126%, while peak plasma concentration (Cmax) increased by up to 149%. The formulations also showed a faster increase in plasma concentrations following subcutaneous administration and maintained excellent physicochemical stability even at high concentrations.
The findings were presented at the ASCPT Annual Meeting in March.
Intellectual Property and Strategic Significance
With the patent registration, Huonslab (搜索) has secured intellectual property rights covering core technologies for ADC subcutaneous formulations. The company emphasized the broader implications of this achievement.
"This patent is meaningful because it demonstrates the applicability of the HyDIFFUZE (搜索) platform to ADCs while expanding its potential applications," a Huonslab (搜索) official said. "We will continue to advance the platform technology and broaden its application across next-generation biopharmaceuticals."
The company also indicated plans to further strengthen the platform's competitiveness through global business development.
Regulatory Progress and Pipeline Expansion
Beyond the ADC formulation patent, Huonslab (搜索) is pursuing marketing authorization from Korea's Ministry of Food and Drug Safety (MFDS) within this year for HYDIZYME Injection (搜索), its standalone recombinant hyaluronidase product. The HyDIFFUZE (搜索) platform continues to expand its application to next-generation biopharmaceuticals, including ADCs.
Founded in 2018 as Huons Group's biologics R&D hub, Huonslab (搜索) leverages its HyDIFFUZE (搜索) platform to convert IV drugs into subcutaneous formulations with the goal of improving patients' quality of life.