HuonsLab Receives Approval for Phase 1 Clinical Trial Plan of Human Hyaluronidase

Huons Lab announced on the 7th that it has received approval from the Ministry of Food and Drug Safety for the clinical phase 1 trial plan (IND) of the recombinant human hyaluronidase HLB3-002.

This phase 1 clinical trial will evaluate the safety and tolerability of a single subcutaneous administration of HLB3-002 in 243 healthy adults. The trial will be conducted at four domestic medical institutions: Seoul National University Hospital, Asan Medical Center, Konkuk University Medical Center, and Chung-Ang University Hospital. Previously, Huons Lab confirmed the equivalent efficacy of HLB3-002 to the original product, Hylenex by Halozyme in the United States, through multiple animal efficacy tests, and also secured safety through non-clinical toxicity tests.

Huons Lab plans to proceed to product approval for HLB3-002 without additional clinical trials through consultation with the Ministry of Food and Drug Safety. Currently, most hyaluronidase products receive approval decisions after completing phase 1 clinical trials. Huons Lab intends to apply for product approval for HLB3-002 as a standalone product to the Ministry of Food and Drug Safety around June next year.

HLB3-002 is an independent product for Hylenex. Unlike existing animal-derived hyaluronidase products, it applies recombinant technology using Chinese hamster ovary (CHO) cell culture and Hyadifuse production technology. Huons Lab completed domestic patent registration for the manufacturing method last month and is also in the process of filing an international patent application (PCT).

Im Chaeyoung, head of Huons Lab Bio Research Center, stated, “HLB3-002 can be used for plastic surgery, dermatology, pain, and edema treatment,” adding, “It will also be useful as a platform technology to convert intravenous drugs into self-administered subcutaneous injections.”