Huonslab Reaches LPI in Phase 1 Trial for Hyaluronidase PH20

South Korea’s Huonslab Co., Ltd, a subsidiary of Huons Global (KOSDAQ: 084110), has reached a major clinical development milestone with the successful completion of patient enrollment in its Phase 1 clinical trial of Hydizyme (HLB3-002), a recombinant human hyaluronidase PH20 (rHuPH20).

This pivotal step brings the company closer to submitting its Biological License Application (BLA) with the Ministry of Food and Drug Safety (MFDS) in the second half of 2025.

Inside the HLB3-002 Phase 1 Study

Registered under NCT06713317, the Phase 1 study is a two-part, randomized, double-blind, placebo-controlled clinical trial involving 243 healthy volunteers. Conducted at four leading clinical centers in South Korea, Seoul National University Hospital, Asan Medical Center, Konkuk University Medical Center, and Chung-Ang University Hospital—the trial aims to thoroughly assess:

• Part 1: Allergenicity of HLB3-002 via a single intradermal injection
• Part 2: Safety profile via a single subcutaneous administration

These top-tier sites were carefully selected to ensure high-quality trial conduct and efficient patient recruitment, both critical for generating robust safety data.

Hydizyme and the HyDIFFUZE Platform

Hydizyme is Huonslab’s flagship product developed using its HyDIFFUZE platform, which employs a proprietary CHO (Chinese Hamster Ovary) cell line and patented manufacturing process. The platform is designed to:

• Enable subcutaneous (SC) delivery of a wide range of drugs
• Serve as a patient-friendly and cost-effective alternative to intravenous (IV) administration
• Expand treatment access and convenience across therapeutic areas

The use of rHuPH20 like Hydizyme™ facilitates enhanced dispersion and absorption of co-administered therapeutics, improving pharmacokinetics and reducing the burden of IV infusions.

Industry Attention and Next Steps

Hydizyme gained international visibility in April 2025 during the AACR Annual Meeting in Chicago, where Huonslab presented promising results of its formulation conversion study using HLB3-002.

The data underscored its potential for clinical utility in oncology and other indications where rapid and effective drug delivery is vital.

A Huonslab official commented:

“This milestone represents an important step in advancing the HLB3-002 development program. The results will provide critical insights into the safety and allergenicity profile of Hydizyme™, laying the groundwork for future clinical trials and regulatory submissions.”

Pending favorable Phase 1 outcomes, Huonslab plans to submit its BLA in H2 2025, with expectations of progressing to Phase 2 trials shortly thereafter.

About Huonslab

Founded in 2018, Huonslab is a biologics-focused R&D powerhouse under Huons Global, a diversified healthcare group with over 2,200 employees worldwide. The company is dedicated to pioneering human hyaluronidase-based biologics, particularly for subcutaneous administration of monoclonal antibodies, biologics, and other complex drugs.

Its HyDIFFUZE™ platform is positioned to unlock new delivery pathways for a wide spectrum of biologics, improving patient adherence, reducing healthcare burdens, and offering pharmaceutical partners new formulation pathways.

Conclusion

As the global biopharma industry shifts towards more patient-centric delivery methods, Hydizyme™ and Huonslab’s HyDIFFUZE™ platform reflect the forefront of this transformation. With the successful completion of this Phase 1 trial and a regulatory filing on the horizon, Huonslab is well-positioned to reshape the future of SC drug delivery, not just in South Korea, but globally.

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