Huonslab has submitted the Biologics License Application for Recombinant Human Hyaluronidase ‘HYDIZYME™ Injection’

- Applying HyDIFFUZE™ technology… Aiming for Approval in 2026 -

Huonslab, subsidiary of Huons Global has entered the final stage for commercializing recombinant human hyaluronidase, targeting approval in the second half of 2026.

Huonslab announced on the 22nd that it has filed for Biologics License Application with the Ministry of Food and Drug Safety (MFDS) for its recombinant human hyaluronidase 'HYDIZYME™’ (Development code: HLB3-002).

The submission is based on the results of a (Pivotal) Phase 1 clinical trial, which enrolled a total of 243 healthy volunteers. The study was conducted at Konkuk University Medical Center, Seoul National University Hospital, Asan Medical Center, and Chung-Ang University Hospital.

The study evaluated safety and tolerability, while no Serious Adverse Events (SAEs) were observed and the trial successfully met its primary endpoint.

HYDIZYME™ contains recombinant human hyaluronidase that shares an identical amino acid sequence with HYLENEX^®, the original product developed by Halozyme Therapeutics. It is a stand-alone drug product manufactured using Huonslab’s proprietary HyDIFFUZE™ manufacturing technology.

Huonslab expects, HYDIZYME™ to be utilized as a stand-alone drug product in aesthetics, dermatology, pain management, and edema treatment upon launch. The company also plans to actively leverage its HyDIFFUZE™ technology platform to develop drug diffusion agents that convert intravenous formulations to subcutaneous formulations.

Huonslab's development and manufacturing of HYDIZYME™ were conducted through collaboration among subsidiaries of Huons Group. The drug substance was manufactured by PanGen Biotech, another subsidiary of Huons, followed by process validation and stability testing. The drug product has completed process validation and stability testing at Humedix based on the Drug Product Specifications, and the filing is based on these Chemistry, Manufacturing, and Control (CMC) data package.

Huonslab Chief Technology Officer, Chae Young Lim stated, "Filing for HYDIZYME™ 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.”

Huonslab is also strengthening its intellectual property portfolio for HYDIZYME™ and related technologies.

In July 2024, method for producing human hyaluronidase PH20 was registered in South Korea. Global patent registrations are also underway in major countries including the United States, Europe, China, Japan, and India. The patented technology encompasses recombinant protein (CHO cell line) and HyDIFFUZE™ production processes, to achieve high-purity, high-yield hyaluronidase in its intact form without degradation byproducts.

In July 2025, patent registration was completed for the pharmaceutical formulation without serum albumin of HyDIFFUZE™ and use of the drug product HYDIZYME™ Injection. International patent (PCT) was also filed. Meanwhile, Halozyme's patent for hyaluronidase expired in South Korea and Europe in 2024. It is scheduled to expire 2027 in the United States.