Huonslab Secures Patent for ADC Subcutaneous Formulation Incorporating ‘HyDIFFUZE™’ Platform

Demonstrates competitiveness of hyaluronidase-based ADC SC conversion platform

Confirms stability of high-concentration ADC SC formulations and improved drug dispersion

PANGYO, South Korea--(BUSINESS WIRE)--Huonslab, the R&D subsidiary of Huons Group (KOSDAQ:084110), announced that it has secured a patent covering a subcutaneous (SC) formulation of an Antibody-Drug Conjugate (ADC) incorporating its proprietary human-derived hyaluronidase-based platform technology, HyDIFFUZE™.

An ADC is a targeted therapeutic combining a monoclonal antibody, which delivers therapeutic agents to target cells such as cancer cells, with a cytotoxic drug. Recently, the global ADC market has been expanding rapidly across diverse indications.

Currently approved ADCs are all administered via intravenous (IV) infusion, driving demand for SC formulation to improve patient convenience and healthcare efficiency. Because ADCs are structurally complex biologics, the development of SC formulations requires advanced formulation technologies capable of simultaneously ensuring stability at high concentrations and efficient subcutaneous drug delivery.

The newly granted patent covers ADC SC formulation technology utilizing the HyDIFFUZE™ platform to enable therapeutics development.

Through formulation studies, Huonslab confirmed that HyDIFFUZE™-enabled ADC SC formulations maintained excellent physicochemical stability even at high concentrations. In nonclinical pharmacokinetic (PK) evaluations, the formulations showed a faster increase in plasma concentrations following SC administration. Compared to formulations without HyDIFFUZE™, systemic drug exposure (AUC) and peak plasma concentration (Cmax) increased by up to 126% and 149%, respectively.

Based on this study, Huonslab expects HyDIFFUZE™-enabled ADC SC formulations to improve early absorption following subcutaneous administration and enhance systemic drug exposure.

The findings were presented at the ASCPT Annual Meeting in March. With the patent registration, Huonslab has also secured intellectual property rights covering core technologies for ADC SC formulations.

“This patent is meaningful because it demonstrates the applicability of the HyDIFFUZE™ platform to ADCs while expanding its potential applications,” a Huonslab official said. “We will continue to advance the platform technology and broaden its application across next-generation biopharmaceuticals.”

Meanwhile, Huonslab is seeking marketing authorization from Korea’s Ministry of Food and Drug Safety (MFDS) within this year for HYDIZYME Injection, its standalone recombinant hyaluronidase product. In addition, the HyDIFFUZE™ platform continues to expand its application to next-generation biopharmaceuticals, including ADCs.

About Huonslab Co., Ltd.

Founded in 2018 as Huons Group’s biologics R&D hub, Huonslab leverages its HyDIFFUZE™ platform to convert IV drugs into SC formulations and improve patients’ quality of life.