Applying HyDIFFUZE™ technology, aiming for Approval by MFDS in 2026

Huonslab, a subsidiary of Huons Global (KOSDAQ:084110), has submitted a Biologics License Application (BLA) to the Ministry of Food and Drug Safety for its recombinant human hyaluronidase HYDIZYME™ (Development code: HLB3-002), targeting approval in the second half of 2026.

The submission is based on the Pivotal Phase 1 clinical trial results, which enrolled a total of 243 healthy volunteers, confirming safety and tolerability with no serious adverse events. The study was conducted at Konkuk University Medical Center, Seoul National University Hospital, Asan Medical Center, and Chung-Ang University Hospital.

HYDIZYME™ is a stand-alone drug product identical in amino acid sequence to HYLENEX^® by Halozyme Therapeutics and is manufactured using Huonslab’s proprietary HyDIFFUZE™ technology.

Huonslab's development and manufacturing of HYDIZYME™ were conducted through collaboration among subsidiaries of Huons Group, PanGen Biotech and Humedix. HYDIZYME™ has currently completed process validation, stability testing, and CMC documentation. Huonslab expects HYDIZYME™ to be utilized as a stand-alone drug product in aesthetics, dermatology, pain management, and edema treatment upon launch.

Huonslab Chief Technology Officer, Chae Young Lim stated, "Submission of the BLA for HYDIZYME™ marks an important milestone in our efforts toward proving the clinical safety and manufacturing robustness of our proprietary recombinant human hyaluronidase technology."

Huonslab is also reinforcing IP portfolio, securing patents in South Korea and globally for its recombinant human hyaluronidase production and formulation technology.

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 hyaluronidase in its intact form without degradation byproducts.

About Huonslab Co., Ltd.

Huonslab, founded in 2018 as biologics R&D hub of Huons Group, develops innovative drug delivery technologies based on its proprietary HyDIFFUZE™ platform. Its recombinant human hyaluronidase, HyDIFFUZE™, enables the conversion of IV drugs to subcutaneous formulations. Huonslab’s pipeline includes candidates for Alzheimer’s disease, obesity, and short bowel syndrome, along with discovery programs on tropoelastin and collagen for medical and skin applications. Through these innovative research efforts, Huonslab aims to advance next-generation biologics and deliver new therapeutic solutions that improve patients’ quality of life.

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"Filing for HYDIZYME™ Injection Biologics License Application, comprehensively proves the clinical safety and manufacturing suitability of our proprietary recombinant human hyaluronidase technology.”