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Huonslab’s Hydizyme enters final stages of commercialization with biologics license application submission

Published: 24 Dec. 2025, 15:44

The Huonslab logo [HUONS GLOBAL]

Huonslab has entered the final stage for the commercialization of its recombinant human hyaluronidase, with the aim of receiving approval in the second half of 2026.

The Huons Global subsidiary announced on Dec. 22 that it has filed a Biologics License Application for Hydizyme with the Ministry of Food and Drug Safety based on the results of a pivotal Phase I clinical trial of 243 test subjects, conducted at the Konkuk University Medical Center, Seoul National University Hospital, Asan Medical Center and Chung-Ang University Hospital.

The study evaluated the safety and tolerability of Hydizyme, with no serious adverse side effects observed.

The pharmaceutical contains recombinant human hyaluronidase that shares an identical amino acid sequence with Hylenex, the original product developed by Halozyme Theraputics.

Hydizyme, designed to be a standalone product manufactured using Huonslab’s proprietary Hydiffuze production technology, is expected to be utilized as a standalone drug product in aesthetics, dermatology, pain management and edema treatment. Huonslab also intends to leverage its Hydiffuze technology platform to develop drug diffusion agents that convert formulations delivered intravenously to products applied under the skin.

The development and manufacturing of Hydizyme was completed through a collaboration of Huons Group subsidiaries, with PanGen Biotech produced the product, while Humedix completed process validation and stability testing based on the drug product specifications, with the filing based on the Chemistry, Manufacturing and Controls data set.

Chae Young-lim, Huonslab’s chief technology officer, said, “Filing Hydizyme’s injection biologics license application comprehensively proves the clinical safety and manufacturing suitability of our proprietary recombinant human hyaluronidase technology. Building on Huons Group’s capabilities in biopharmaceutical development and manufacturing, we will ensure thorough preparation through to the product commercialization stage following approval.”

The company has also been strengthening its intellectual property portfolio for Hydizyme and other related technologies since the method for production human hyaluronidase PH20 was registered in Korea in July 2024. Patents registrations have been filed in such markets as the United States, Europe, China, Japan and India, including technology that encompasses the production processes for recombinant proteins from Chinese hamster ovary cells and Hydiffuze to achieve high-purity, high-yield hyaluronidase in its complete form without any degradation.

In July of this year, the company completed the registration of a patent for the pharmaceutical formulation of Hydiffuze without serum albumin as well as for the use of Hydizyme, while international patents were also filed, with Halozyme’s patent for hyaluronidase expiring in Korea and Europe in 2024 and scheduled to expire in the United States in 2027.

BY LEE DAHYUN [[email protected]]

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