Huonslab Achieves ‘Last-Patient-In (LPI)’ in Phase 1 Pivotal Study for Recombinant Human Natural Hyaluronidase PH20 (rHuPH20)

- Phase 1 Pivotal Study in Korea for HLB3-002 -

- Plans to apply for marketing approval with the MFDS by the 2H 2025 -

 

Huonslab Co. Ltd (“Huonslab”), a subsidiary of Huons Global (KOSDAQ: 084110), has announced on May 26 the successful completion of patient enrollment in its pivotal phase 1 clinical trial of Hydizyme™ (recombinant human natural hyaluronidase PH20, HLB3-002), marking a significant milestone in the ongoing the HLB3-002 development program. HLB3-002 Phase 1 Study (NCT06713317) was designed to evaluate the safety and allergenicity of HLB3-002 in 243 healthy volunteers.

The study is being conducted as two-part, randomized, double-blind, placebo-controlled study, the first part focuses on evaluating allergenicity of HLB3-002 upon single intradermal administration of HLB3-002, while the second part focuses on evaluating safety of HLB3-002 upon single subcutaneous administration. The study is ongoing at four leading medical institutions in South Korea, known for the excellence in clinical research: Seoul National University Hospital, Asan Medical, Konkuk University Medical Center, and Chung-Ang University Hospital. The participating sites were selected to support consistent trial conduct and participant recruitment.

Huonlab expects to submit a Biological License Application (BLA) for marketing approval with the MFDS by the second half of this year, pending trial outcomes.

Huonslab’s official said, “This milestone represents an important step in advancing the HLB3-002 development program. The results of this phase 1 will provide Huonslab with important insights into the safety and allergenicity profile of HLB3-002, laying solid foundation for future clinical trial and regulatory submission.”

In April, Huonslab attracted much attention at the 2025 Annual Meeting of the American Association for Cancer Research (AACR 2025), held in Chicago, when the company announced the result of formulation conversion using recombinant human hyaluronidase ‘HLB3-002’ (also known as rHuPH20) in a poster presentation

 

About Hydizyme™ (rHuPH20, HLB3-002)

Hydizyme™ is being developed as a stand-alone, proprietary alternative to Halozyme Therapeutics’ Hylenex®. Unlike existing animal-derived hyaluronidase products, which derived from animal tissues, HLB3-002 is manufactured using recombinant CHO cell line and Huonslab process patented manufacturing technology for HyDIFFUZE^TM, which is Huonslab’s proprietary subcutaneous (SC) delivery platform technology.  

About Huonslab

Huonslab, a subsidiary of Huons Global (KOSDAQ: 084110) based in South Korea, stands as a leader in biologics research and development. The company is committed to pushing the boundaries of therapeutics through the creation of innovative drug development and delivery technologies. A cornerstone of its mission is the development of solutions for universal subcutaneous delivery, exemplified by HyDIFFUZE^TM. Huonslab’s specialization includes its proprietary subcutaneous (SC) drug delivery platform. HyDIFFUZE^TM is defined as highly purified recombinant human natural hyaluronidase (PH20), a glycoprotein with a molecular weight of 61 kDa. Its co-formulation with partner therapeutics streamlines the subcutaneous delivery of various therapeutic modalities, thereby offering a more patient-friendly and economically advantageous alternative to traditional intravenous administration.