Huonslab Submits Biologics License Application for Recombinant Human Hyaluronidase HYDIZYME™
核心洞察
Huonslab (搜索) has submitted a Biologics License Application to South Korea's Ministry of Food and Drug Safety for HYDIZYME™ (搜索), targeting approval in the second half of 2026.
The submission is based on pivotal Phase 1 clinical trial results from 243 healthy volunteers, confirming safety and tolerability with no serious adverse events.
HYDIZYME™ (搜索) is manufactured using Huonslab (搜索)'s proprietary HyDIFFUZE™ technology and is identical in amino acid sequence to Halozyme's HYLENEX® (搜索).
Huonslab (搜索), a subsidiary of Huons Global (搜索) (KOSDAQ:084110), has submitted a Biologics License Application (BLA) to South Korea's Ministry of Food and Drug Safety for its recombinant human hyaluronidase HYDIZYME™ (搜索) (Development code: HLB3-002), targeting regulatory approval in the second half of 2026.
Clinical Trial Results Support Regulatory Submission
The BLA submission is based on pivotal Phase 1 clinical trial results that enrolled a total of 243 healthy volunteers. The study confirmed safety and tolerability with no serious adverse events reported. The clinical trial was conducted across four major medical centers in South Korea: Konkuk University Medical Center, Seoul National University Hospital, Asan Medical Center, and Chung-Ang University Hospital.
HYDIZYME™ (搜索) is positioned as a stand-alone drug product that is identical in amino acid sequence to HYLENEX® (搜索) by Halozyme Therapeutics. The product is manufactured using Huonslab (搜索)'s proprietary HyDIFFUZE™ technology platform.
Manufacturing and Development Collaboration
The development and manufacturing of HYDIZYME™ (搜索) were conducted through collaboration among subsidiaries of Huons Group, including PanGen Biotech (搜索) and Humedix (搜索). The company has completed process validation, stability testing, and Chemistry, Manufacturing, and Controls (CMC) documentation for the product.
Huonslab (搜索) expects HYDIZYME™ (搜索) to be utilized as a stand-alone drug product across multiple therapeutic areas including aesthetics, dermatology, pain management, and edema (搜索) treatment upon market launch.
Intellectual Property Portfolio Expansion
Huonslab (搜索) is strengthening its intellectual property portfolio by securing patents in South Korea and globally for its recombinant human hyaluronidase production and formulation technology. In July 2024, the company registered its method for producing human hyaluronidase PH20 (搜索) in South Korea.
Global patent registrations are currently underway in major markets including the United States, Europe, China, Japan, and India. The patented technology encompasses recombinant protein production using CHO cell lines and HyDIFFUZE™ production processes designed to achieve high-purity hyaluronidase in its intact form without degradation byproducts.
Company Leadership Perspective
"Submission of the BLA for HYDIZYME™ (搜索) marks an important milestone in our efforts toward proving the clinical safety and manufacturing robustness of our proprietary recombinant human hyaluronidase technology," stated Chae Young Lim, Huonslab (搜索)'s Chief Technology Officer.
About Huonslab's Technology Platform
Founded in 2018 as the biologics R&D hub of Huons Group, Huonslab (搜索) develops innovative drug delivery technologies based on its proprietary HyDIFFUZE™ platform. The company's recombinant human hyaluronidase technology enables the conversion of intravenous drugs to subcutaneous formulations.
Huonslab (搜索)'s pipeline includes candidates for Alzheimer's disease (搜索), obesity (搜索), and short bowel syndrome (搜索), along with discovery programs focused on tropoelastin and collagen for medical and skin applications. Through these research efforts, the company aims to advance next-generation biologics and deliver therapeutic solutions designed to improve patients' quality of life.