Huonslab Co., Ltd., a South Korean biologics company and subsidiary of Huons Global (KOSDAQ:084110), has achieved last-patient-in status for its pivotal Phase 1 clinical trial of HLB3-002 (Hydizyme™), a recombinant human natural hyaluronidase PH20. The milestone marks a critical advancement in the company's development program for subcutaneous drug delivery enhancement technology.
Phase 1 Trial Design and Scope
The Phase 1 study (NCT06713317) enrolled 243 healthy volunteers in a two-part, randomized, double-blind, placebo-controlled design. The first component evaluates allergenicity following single intradermal administration of HLB3-002, while the second part assesses safety after single subcutaneous administration. This dual-approach methodology provides comprehensive safety and tolerability data essential for regulatory submission.
The trial is being conducted across four prestigious South Korean medical institutions: Seoul National University Hospital, Asan Medical Center, Konkuk University Medical Center, and Chung-Ang University Hospital. These sites were strategically selected for their clinical research excellence and ability to ensure consistent trial conduct and robust participant recruitment.
Regulatory Timeline and Commercial Strategy
Huonslab anticipates submitting a Biological License Application (BLA) to South Korea's Ministry of Food and Drug Safety (MFDS) by the second half of 2025, contingent on favorable trial outcomes. This timeline positions the company for potential market entry within the next two years, assuming successful regulatory review.
"This milestone represents an important step in advancing the HLB3-002 development program," stated a Huonslab official. "The results of this phase 1 will provide Huonslab with important insights into the safety and allergenicity profile of HLB3-002, laying a solid foundation for future clinical trials and regulatory submission."
Technology Platform and Market Positioning
HLB3-002 is the lead candidate from Huonslab's proprietary HyDIFFUZE™ platform, which utilizes recombinant CHO cell line manufacturing and patented processes. The technology aims to facilitate subcutaneous delivery of various therapeutic modalities, offering a patient-friendly and economically advantageous alternative to traditional intravenous administration.
The company's approach addresses a significant unmet need in drug delivery, as subcutaneous administration can reduce healthcare facility burden, improve patient compliance, and potentially lower treatment costs compared to IV infusion requirements.
Recent Scientific Presentations
In April 2025, Huonslab presented formulation conversion data using HLB3-002 at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, demonstrating the company's commitment to advancing the scientific understanding of hyaluronidase-enhanced drug delivery.
Company Background
Founded in 2018, Huonslab focuses specifically on developing human hyaluronidase-based biologics for subcutaneous delivery applications. As part of Huons Global, a healthcare conglomerate with over 2,200 employees worldwide, the company leverages substantial resources and expertise in biologics research and development.
The successful completion of enrollment represents a significant operational achievement for Huonslab, positioning the company to generate critical safety and efficacy data that will inform both regulatory strategy and future clinical development plans for its hyaluronidase platform technology.
