What's Happening?
Huonslab, a subsidiary of Huons Global, has submitted a Biologics License Application (BLA) to South Korea's Ministry of Food and Drug Safety for its recombinant human hyaluronidase product, HYDIZYME. The application is based on successful Phase 1 clinical trials involving 243 healthy volunteers, which confirmed the product's safety and tolerability without any serious adverse events. HYDIZYME, developed using Huonslab's proprietary HyDIFFUZE technology, is intended for use in aesthetics, dermatology, pain management, and edema treatment. The company aims for approval in the second half of 2026. The development and manufacturing of HYDIZYME involved collaboration with PanGen Biotech and Humedix, subsidiaries of Huons Group. The product is identical
in amino acid sequence to HYLENEX by Halozyme Therapeutics and has completed process validation, stability testing, and CMC documentation.
Why It's Important?
The submission of the BLA for HYDIZYME represents a significant milestone for Huonslab, as it seeks to expand its presence in the global biologics market. The approval of HYDIZYME could enhance treatment options in various medical fields, potentially improving patient outcomes in aesthetics and pain management. Additionally, the successful commercialization of HYDIZYME could strengthen Huonslab's competitive position and contribute to its financial growth. The company's efforts to secure patents globally, including in the United States, Europe, and China, underscore its commitment to protecting its intellectual property and expanding its market reach. This development also highlights the growing importance of biologics in the pharmaceutical industry, as companies seek innovative solutions to meet diverse medical needs.
What's Next?
Huonslab is awaiting the decision from the Ministry of Food and Drug Safety, expected in the second half of 2026. In the meantime, the company is reinforcing its intellectual property portfolio by securing patents for its recombinant human hyaluronidase production and formulation technology. Global patent registrations are underway in major markets, which could facilitate future international expansion. The company is also advancing its pipeline, which includes candidates for Alzheimer's disease, obesity, and short bowel syndrome, as well as research on tropoelastin and collagen for medical and skin applications. These efforts indicate Huonslab's strategic focus on developing next-generation biologics and expanding its therapeutic offerings.
