Huonslab Secures Key Patent for Albumin-Free Hyaluronidase Formulation, Advances Toward 2026 Market Authorization
Key Insights
Huonslab obtained a South Korean patent for an albumin-free formulation of HYDIZYME (search)™, its recombinant human hyaluronidase product, enhancing stability under refrigerated conditions.
The company completed patient enrollment for HYDIZYME (search)™ clinical trials and plans to submit marketing application to South Korea's MFDS in the second half of 2025.
HYDIZYME (search)™ serves as a drug diffusion enhancer through the proprietary HyDIFFUZE™ platform, enabling conversion of intravenous biologics to subcutaneous formulations.
Huonslab Co., Ltd. (search), a subsidiary of Huons Global (search) (KOSDAQ:084110), has secured a crucial patent for its recombinant human hyaluronidase product HYDIZYME (search)™ in South Korea, marking a significant milestone toward obtaining marketing authorization by 2026. The newly granted patent covers a pharmaceutical formulation without serum albumin that demonstrates enhanced stability for the hyaluronidase enzyme.
Enhanced Formulation Stability
The albumin-free formulation represents a major advancement in product development, as it maintains potency and purity without degradation under refrigerated conditions. This stability improvement secures the product integrity for the finished dosage form of HYDIZYME (search)™ (Recombinant Human Hyaluronidase PH20, HLB3-002), addressing critical manufacturing and storage challenges.
The patent builds upon Huonslab's previous intellectual property achievement from July 2024, when the company registered a patent for the manufacturing method of intact recombinant hyaluronidase. Together, these patents significantly strengthen the company's intellectual property portfolio related to recombinant human hyaluronidase technology.
Clinical Progress and Regulatory Timeline
Chief Technology Officer Chae Young Lim announced that the company has successfully completed patient enrollment for the HYDIZYME (search)™ clinical trial. "We plan to submit the marketing application to South Korea's Ministry of Food and Drug Safety (search) (MFDS) in the second half of 2025 with a complete data package," Lim stated.
The regulatory submission timeline positions Huonslab to achieve its goal of obtaining marketing authorization by 2026, representing a critical step in bringing this drug delivery enhancement technology to market.
HyDIFFUZE™ Platform Technology
HYDIZYME (search)™ operates through a novel mechanism utilizing hyaluronidase, an enzyme that temporarily degrades hyaluronic acid in the subcutaneous space. This action enhances the dispersion and absorption of co-administered drugs, enabling more effective subcutaneous delivery.
Through this mechanism, Huonslab is developing its proprietary HyDIFFUZE™ platform technology to convert intravenous biologics, including monoclonal antibodies (search), into subcutaneous formulations. "We will continue to expand the use of our HyDIFFUZE™ platform as a drug diffusion enhancer and accelerate the development of more convenient subcutaneous injectable formulations," Lim added.
Global Patent Strategy
The manufacturing method patent is currently under examination or has been filed in key international markets including Japan, China, India, Europe, and the United States. The newly registered formulation patent in Korea will also undergo Patent Cooperation Treaty (PCT) filing, aiming to secure intellectual property rights in major global markets.
This comprehensive patent strategy positions Huonslab to protect its hyaluronidase technology across multiple jurisdictions, supporting potential international commercialization efforts following regulatory approval.
Huonslab was established in 2018 as a dedicated biologics research and development organization, focusing on innovation in human hyaluronidase-based biologics through its proprietary subcutaneous drug delivery platform technology.