On April 2, 2025 Huonslab Co., Ltd. ("Huonslab"), a subsidiary of Huons Global (KOSDAQ: 084110), reported that its abstract titled "The Role of HyDIFFUZE in Co-formulation with Subcutaneous Infliximab" has been selected for poster presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place on April 28, 2025 (Press release, Huons Global, APR 2, 2025, View Source [SID1234651773]).
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The study demonstrated that HyDIFFUZE (rHuPH20) significantly improves the relative bioavailability of co-formulated infliximab compared to infliximab without rHuPH20 when administered subcutaneously.
These findings suggest that co-formulation with HyDIFFUZETM (rHuPH20) may reduce the required dose of infliximab while maintaining equivalent therapeutic efficacy and potentially extending dosing interval in the maintenance regimen.
Huonslab previously validated the role of HyDIFFUZE (rHuPH20) as a locally acting, transient permeation enhancer for subcutaneous delivery of high-dose, high-volume biotherapeutics, supported by dye dispersion studies in nude mice and in vivo comparative pharmacokinetic (PK) studies in Sprague-Dawley rats.
In parallel, Huonslab is currently conducting a pivotal Phase 1 clinical trial in South Korea for Hydizyme, a stand-alone recombinant human hyaluronidase (rHuPH20) drug product, with the goal of obtaining product approval from the Ministry of Food and Drug Safety (MFDS) by 2026.
"Huonslab is committed to converting high-dose, high-volume antibody-based biotherapeutics from intravenous (IV) infusion to subcutaneous (SC) injection using human hyaluronidase PH20," said Dr. Young Sun Lee, Chief Business Officer of Huonslab.
Lee added, "Our HyDIFFUZE (rHuPH20) drug delivery technology is redefining the landscape of SC antibody development and expanding patient access to more convenient and effective subcutaneous antibody therapies."