Huonslab Receives Patent for HyDIFFUZETM and MFDS IND Clearance for HLB3-002

Huonslab Co. Ltd., a subsidiary of Huons Global, recently secured a process patent from the Korean Intellectual Property Office (KIPO) for its innovative HyDIFFUZE™ and rHuPH20 production methods. This patent underscores significant advancements in both upstream and downstream processes for manufacturing recombinant human hyaluronidase, PH20 (rHuPH20). Huonslab’s next steps include filing international patent applications across the United States, Europe, Australia, Japan, and China to further protect their intellectual property globally.

In parallel, Huonslab has received approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for an Investigational New Drug Application (IND) for their product HLB3-002, which is also based on recombinant human hyaluronidase PH20. This IND approval marks a crucial step towards Huonslab’s goal to advance to a Phase 1 clinical study and eventually file for a Biological License Application (BLA) with the MFDS by 2025. The Phase 1 study aims to assess the safety and tolerability of HLB3-002 in 243 healthy volunteers across four prominent clinical institutions in South Korea.

In preclinical animal trials, HLB3-002 has demonstrated comparable efficacy and safety to Hylenex, a product by Halozyme US, which is the only FDA-approved human hyaluronidase currently available on the market. Hylenex is widely used as a dispersion agent and permeation enhancer for co-administered drugs.

Dr. Young Sun Lee, Chief Business Officer of Huonslab, expressed his enthusiasm about the recent achievements. He highlighted that the process patent granted by KIPO and the IND approval for HLB3-002 both serve as public recognition for Huonslab’s groundbreaking work in the field of biologics subcutaneous (SC) delivery. According to Dr. Lee, these milestones bolster Huonslab’s position in the industry and reinforce their commitment to revolutionizing the delivery of high-dose, high-volume biologics.

Established in 2018, Huonslab operates as a specialized research and development branch of Huons Global Co., Ltd., a fast-growing company in the bio, pharmaceuticals, and healthcare sectors with over 2,200 employees worldwide. Huonslab focuses on innovating human hyaluronidase-based biologics SC delivery through its proprietary platform, HyDIFFUZE™.

Huonslab’s research pipeline is both well-balanced and patient-centric. Besides HLB3-002, which is currently in Phase 1, the company is also working on various non-clinical developments targeting Alzheimer’s disease, obesity, and diabetes. This diverse portfolio underscores Huonslab’s commitment to advancing healthcare solutions and improving patient outcomes through innovative biologics.