Huonslab Announces Issuance of Process Patent for HyDIFFUZETM Drug Delivery Platform and MFDS IND Clearance for HLB3-002

- A striking success in the development of HyDIFFUZE^TM, a recombinant human hyaluronidase-based SC Delivery platform including HLB3-002

SEONGNAM, South Korea--(BUSINESS WIRE)--Huonslab, Co. Ltd. (“Huonslab”), a subsidiary of Huons Global (KOSDAQ: 084110) today announced the registration of process patent covering the HyDIFFUZE™, rHuPH20 manufacturing methods by KIPO (Korean Intellectual Property Office).

The invention of Huonslab process patent relates to an improved upstream and downstream process for production of recombinant human hyaluronidase, PH20 (rHuPH20).

Huonslab will file the international patent application in the United States, Europe, Australia, Japan and in China, sequentially.

In addition, South Korea’s MFDS (Ministry of Food and Drug Safety) approved the Investigational New Drug Application (IND) for HLB3-002 (recombinant human hyaluronidase PH20) allowing Huonslab to proceed with P1 study, which is pivotal for the Biological License Application (BLA) with the MFDS, S. Korea.

Huonslab plans to complete P1 and apply for the BLA in 2025.

The Phase 1 study will evaluate safety and tolerability of HLB3-002 in 243 healthy volunteers at 4 leading clinical institutions in South Korea.

In several animal studies, non-clinical efficacy and safety of HLB3-002 have been confirmed as comparable to Hylenex, Halozyme US, the only FDA approved human hyaluronidase and marketed as a dispersion agent and a permeation enhancer for the co-administered drugs.

“We are thrilled with the process patent granted by KIPO, and IND approval for HLB3-002 receiving public recognition for Huonslab and HyDIFFUZE™, a rHuPH20-based biologics SC delivery platform. Furthermore, it fortifies our position in the industry and strengthens our endeavor to revolutionize high-dose, high-volume biologics SC delivery field,” stated Dr. Young Sun Lee, the CBO at Huonslab.

About Huonslab Co., Ltd.

Huonslab is a subsidiary of Huons Global Co., Ltd., S. Korea, a fast-paced Bio, Pharmaceuticals & Healthcare business holding company with more than 2,200 employees, worldwide.

Huonslab was established in 2018 as a dedicated biologics R&D organization and with a mission to innovate in the human hyaluronidase-based biologics SC delivery field with its proprietary drug delivery platform, HYDIFFUZE™.

Huonslab has a well-balanced and patient-centric pipeline including HLB3-002 as a lead candidate in P1, and followed by other non-clinical developments in Alzheimer’s, Obesity and Diabetes.