Huonslab Secures Formulation Patent for Recombinant Human Hyaluronidase Product, HYDIZYME™

 

A major step toward product launch with improved formulation stability

Huonslab, a subsidiary of Huons Global, announced that it has obtained a patent for the formulation without serum albumin of HYDIZYME™ (Recombinant Human Hyaluronidase PH20, HLB3-002) in South Korea, bringing it closer to its goal of obtaining marketing authorization by 2026.

The newly granted patent covers a pharmaceutical formulation with enhanced stability containing hyaluronidase. According to the company, this formulation without serum albuminmaintains its potency and purity without degradation under refrigerated conditions, securing product stability for the finished dosage form of HYDIZYME™.

This follows the company’s previous patent registration in July last year for a manufacturing method for the intact form of recombinant hyaluronidase. With the addition of the serum albumin-free formulation patent, Huonslab has significantly strengthened its intellectual property (IP) portfolio related to recombinant human hyaluronidase.

The manufacturing method patent is currently under examination or has been filed in key markets including Japan, China, India, Europe, and the United States. The newly registered formulation patent in Korea will also undergo PCT (Patent Cooperation Treaty) filing, aiming to secure IP rights in major global markets.

Chief Technology Officer (CTO) of Huonslab, Chae Young Lim, stated, “We have successfully completed last patient enrollment for the HYDIZYME™ clinical trial, and we plan to submit the marketing application to South Korea’s Ministry of Food and Drug Safety (MFDS) in the second half of 2025 with a complete data package.” He added, “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.”

HYDIZYME™ utilizes hyaluronidase, an enzyme that temporarily degrades hyaluronic acid in the subcutaneous space, enhancing the dispersion and absorption of co-administered drugs. Through this mechanism, Huonslab is developing its proprietary HyDIFFUZE™ platform technology to convert intravenous (IV) biologics, such as monoclonal antibodies, into subcutaneous (SC) formulations.

About Huonslab Co., Ltd.

Huonslab was established in 2018 as a dedicated biologics R&D organization and with a mission to innovate human hyaluronidase-based biologics with its proprietary subcutaneous (SC) drug delivery platform technology, HyDIFFUZE™.

Contacts

Dr. Byung Ha Lee

Chief Business Officer

blee@huonslab.com