Huonslab Secures Patent for Subcutaneous Injection Formulation Comprising Therapeutic Antibody and ‘HyDIFFUZE™’ Platform

Huonslab Secures Patent for Subcutaneous Injection Formulation Comprising Therapeutic Antibody and ‘HyDIFFUZE™’ Platform

• Evaluates pharmacokinetic characteristics after applying HyDIFFUZE™ to 11 antibodies, including Pembrolizumab
• Confirms potential for platform expansion following ADC SC formulations

Huonslab, the R&D subsidiary of Huons Global (KOSDAQ: 084110), has secured intellectual property (IP) rights to expand the application scope of its recombinant human-derived hyaluronidase-based formulation conversion platform technology, HyDIFFUZE™.

Huonslab announced that it has secured patent registration and completed PCT international patent filing for 11 pharmaceutical formulations for subcutaneous (SC) injection comprising therapeutic antibody and hyaluronidase, HyDIFFUZE™. Huonslab plans to proceed with patent applications in individual overseas countries.

Huonslab applied HyDIFFUZE™ to antibody therapeutics—including Pembrolizumab, Bevacizumab, Obinutuzumab, Ramucirumab, Donanemab, Isatuximab, Durvalumab, Dostarlimab, Cetuximab, Risankizumab, and Dupilumab—and evaluated their pharmacokinetic (PK) characteristics.

In non-clinical PK evaluations, the SC administration group treated with HyDIFFUZE™ demonstrated a peak plasma concentration (Cmax) and systemic drug exposure (Area Under the Curve, AUC) of approximately 113% to 170%, and 117% to 162%, respectively, compared to the SC administration group without HyDIFFUZE™. These results confirm that applying HyDIFFUZE™ to antibody therapeutics for SC administration can improve systemic drug exposure.

Huonslab expects to develop SC formulation-converted drugs using HyDIFFUZE™ across various antibodies, rather than being limited to specific ones.

In the global biopharmaceutical market, interest in SC formulations continues to rise as they enhance patient convenience and shorten administration time in medical institutions. As efforts are growing to convert antibody therapeutics traditionally administered via intravenous (IV) injection into SC formulations, SC drug delivery platforms capable of effectively delivering high-dose antibody therapeutics are gaining attention.

Lim Chae-young, Chief Technical Officer at Huonslab, stated, "This patent registration is significant in that we have confirmed the applicability of HyDIFFUZE™ to various antibody therapeutics, rather than a specific antibody, and secured our IP rights." He added, "We plan to expand the application scope of HyDIFFUZE™ to various biotherapeutics, while continuously strengthening our IP rights and commercialization foundation."

Huonslab is promoting R&D and commercialization for the SC conversion of various biotherapeutics, including Antibody-Drug Conjugates (ADCs). Huonslab has recently expanded its platform application scope and IP portfolio by registering patents for ADC applications using hyaluronidase. Meanwhile, Huonslab is undergoing regulatory review by South Korea’s Ministry of Food and Drug Safety to secure marketing authorization for HYDIZYME™ Injection, its standalone recombinant hyaluronidase product.

Dr. Byung Ha Lee
Chief Business Officer
blee@huonslab.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20260831002276/en/