Huonslab Expands Intellectual Property Portfolio for HyDIFFUZE™ Platform to Advance Subcutaneous Biologic Drug Delivery
Huonslab, the research and development subsidiary of Huons Global (KOSDAQ: 084110), has strengthened its position in the rapidly evolving biologics market by securing new intellectual property rights for its proprietary formulation conversion platform, HyDIFFUZE™. The company announced that it has obtained patent registration and completed Patent Cooperation Treaty (PCT) international patent filings covering 11 pharmaceutical formulations designed for subcutaneous (SC) administration of antibody therapeutics in combination with recombinant human-derived hyaluronidase.
The move represents an important milestone in Huonslab’s strategy to expand the use of HyDIFFUZE™ beyond individual products and establish the platform as a versatile technology capable of supporting a broad range of biologic medicines. Following the international filings, the company plans to pursue patent applications in individual countries to further strengthen global protection for the technology.
Growing Demand for Subcutaneous Drug Delivery
The global biopharmaceutical industry has seen increasing interest in subcutaneous drug formulations in recent years, driven by a desire to improve patient convenience, reduce treatment time, and ease the burden on healthcare systems. Many antibody therapies currently require intravenous (IV) infusion, which often involves lengthy administration times and hospital visits.
Subcutaneous administration offers several potential advantages, including shorter treatment sessions, improved patient comfort, and the possibility of administration outside traditional infusion settings. As a result, pharmaceutical companies are actively exploring technologies that can convert IV-based therapies into SC formulations while maintaining or improving therapeutic effectiveness.
This trend has created growing demand for advanced drug delivery platforms capable of enabling high-dose biologic therapies to be administered through subcutaneous injection. Hyaluronidase-based technologies have become a key area of interest because they help increase tissue permeability, allowing larger molecules and higher drug volumes to be delivered more efficiently.
Huonslab’s HyDIFFUZE™ platform has been developed to address this need by utilizing recombinant human-derived hyaluronidase to facilitate the subcutaneous delivery of complex biologic therapies.
Broad Application Across Antibody Therapeutics
A notable aspect of Huonslab’s recent patent activity is the wide range of antibody therapies included in the filings. Rather than focusing on a single medicine, the company evaluated the potential of HyDIFFUZE™ across multiple commercially important biologic products.
The antibody therapeutics assessed include:
- Pembrolizumab
- Bevacizumab
- Obinutuzumab
- Ramucirumab
- Donanemab
- Isatuximab
- Durvalumab
- Dostarlimab
- Cetuximab
- Risankizumab
- Dupilumab
These medicines are used across a variety of therapeutic areas, including oncology, immunology, inflammatory diseases, neurology, and autoimmune disorders. The ability to apply a single platform technology across such a broad range of biologics highlights the versatility and potential commercial value of HyDIFFUZE™.
According to Huonslab, pharmacokinetic evaluations were conducted to examine how the platform affects drug absorption and systemic exposure when antibody therapeutics are delivered subcutaneously.
Positive Pharmacokinetic Findings
Non-clinical pharmacokinetic studies showed promising results for formulations incorporating HyDIFFUZE™. Compared with conventional subcutaneous administration without the platform, the HyDIFFUZE™-enabled formulations demonstrated significant improvements in both peak plasma concentration (Cmax) and overall systemic drug exposure, measured by area under the curve (AUC).
The studies indicated that:
- Peak plasma concentration increased by approximately 113% to 170%.
- Systemic exposure increased by approximately 117% to 162%.
These findings suggest that HyDIFFUZE™ may improve the efficiency of subcutaneous drug delivery and help achieve therapeutic drug levels comparable to or potentially exceeding those seen with standard approaches.
Enhanced systemic exposure is particularly important for biologic therapies because maintaining adequate concentrations of therapeutic antibodies is essential for achieving clinical benefit. By improving absorption and distribution, HyDIFFUZE™ may support the development of effective SC formulations for medicines that have traditionally required intravenous administration.
The results also support Huonslab’s broader goal of establishing the platform as a flexible solution that can be applied to multiple classes of biologic drugs rather than being restricted to a limited number of molecules.
Building a Strong Intellectual Property Foundation
Securing patents is a critical element in the commercialization of pharmaceutical technologies, especially in highly competitive areas such as biologics and drug delivery systems.
Huonslab’s patent registrations and international filings strengthen the company’s ability to protect its innovations while supporting future licensing, partnership, and commercialization opportunities. The broad scope of the patents could provide a competitive advantage by covering multiple therapeutic antibodies and enabling future product development efforts.
Lim Chae-young, Chief Technical Officer at Huonslab, emphasized the significance of the patent achievements, noting that they demonstrate the applicability of HyDIFFUZE™ across a diverse range of antibody therapeutics rather than being confined to a specific product.
According to Lim, the company intends to continue expanding the platform’s use across various biologic medicines while strengthening its intellectual property portfolio and laying the groundwork for commercialization.
Expansion into Antibody-Drug Conjugates and Other Biologics
Huonslab’s ambitions extend beyond traditional monoclonal antibodies. The company is actively pursuing research and development programs aimed at converting additional categories of biologics into subcutaneous formulations.
One area of interest is Antibody-Drug Conjugates (ADCs), a rapidly growing class of targeted therapies that combine antibodies with potent therapeutic agents. ADCs have emerged as an important treatment option in oncology, but many currently require intravenous administration.
Huonslab has already expanded its intellectual property portfolio by securing patents related to ADC applications involving hyaluronidase technology. This suggests that the company sees opportunities to apply HyDIFFUZE™ to increasingly sophisticated biologic medicines.
If successful, such applications could broaden the commercial relevance of the platform and position Huonslab as an important player in next-generation drug delivery technologies.
The ability to transform complex biologics into more convenient SC formulations may offer advantages for patients, healthcare providers, and pharmaceutical companies alike. Reduced administration times could lower healthcare costs, improve patient adherence, and make advanced therapies more accessible.
Progress Toward Commercialization
In addition to platform development, Huonslab is also advancing standalone products based on recombinant hyaluronidase technology.
The company is currently undergoing regulatory review by South Korea’s Ministry of Food and Drug Safety (MFDS) for marketing authorization of HYDIZYME™ Injection, its recombinant human hyaluronidase product.
Approval of HYDIZYME™ would provide Huonslab with a commercial product while also supporting broader applications of its technology platform. Regulatory success could strengthen confidence in the company’s capabilities and facilitate future collaborations with pharmaceutical partners interested in developing SC formulations.
Positioning for Future Growth
The biopharmaceutical industry continues to move toward therapies that offer greater convenience, efficiency, and patient-centered care. Subcutaneous administration is increasingly viewed as an important component of this transition, particularly for biologic medicines that have traditionally depended on intravenous delivery.
Huonslab’s recent patent achievements demonstrate the company’s commitment to building a versatile technology platform that can support this evolution. By combining recombinant human-derived hyaluronidase with a broad range of therapeutic antibodies, the company aims to create new opportunities for biologic drug development.
The expansion of HyDIFFUZE™ across multiple therapeutic categories, combined with growing intellectual property protection and ongoing commercialization efforts, positions Huonslab to play a meaningful role in the future of drug delivery innovation.
As the company advances regulatory reviews, pursues additional patents, and explores collaborations across the global pharmaceutical industry, HyDIFFUZE™ could become an increasingly important platform for transforming how biologic medicines are delivered and experienced by patients worldwide.