Huonslab Achieves Last-Patient-In (LPI) in Phase 1 Pivotal Study for Recombinant Human Natural Hyaluronidase PH20
Plans to apply for marketing approval with the MFDS by the 2H 2025
PANGYO, South Korea, May 26, 2025--(BUSINESS WIRE)--Huonslab Co., Ltd. ("Huonslab"), a subsidiary of Huons Global (KOSDAQ:084110) has announced the successful completion of patient enrollment in its pivotal phase 1 clinical trial of Hydizyme™ (recombinant human natural hyaluronidase PH20; rHuPH20; HLB3-002), marking a significant milestone in the ongoing 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 a 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 their excellence in clinical research: Seoul National University Hospital, Asan Medical Center, Konkuk University Medical Center, and Chung-Ang University Hospital. The participating sites were selected to support consistent trial conduct and participant recruitment.
Huonslab 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 a solid foundation for future clinical trials 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 in a poster presentation.
About Huonslab
Huonslab, a South Korean biologics R&D leader and subsidiary of Huons Global (KOSDAQ:084110), is a fast-paced Bio, Pharmaceuticals & Healthcare business holding company with more than 2,200 employees, worldwide.
Huonslab was established in 2018 to innovate human hyaluronidase-based biologics for subcutaneous (SC) delivery. Its proprietary HyDIFFUZE™ platform, manufactured with a recombinant CHO cell line and patented process, offers a patient-friendly and economical alternative to traditional intravenous (IV) delivery by streamlining SC administration of various therapeutic modalities.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250526729798/en/
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Media Contact Dr. Byung Ha LeeChief Business Officerblee@huonslab.com
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