HuonsLab "Recombinant Human Hyaluronidase Confirmed Equivalent to Original"

"Clinical Application Early Next Year... Targeting Product Approval by the End of 2025"

Huons Lab announced on the 24th that it recently conducted an additional comparative test between the recombinant human hyaluronidase 'HLB3-002' under development and the original drug Halozym's hyaluronidase, confirming equivalent efficacy and reliable results.

Huons Lab CI.
[Image provided by Huons]

Hyaluronidase is an enzyme that breaks down hyaluronic acid present in the subcutaneous tissue of the human body. It increases the permeability of subcutaneous tissue, accelerating the diffusion rate of drugs and enabling absorption into blood vessels beneath the skin, thus serving as a drug diffusion agent. When used alone, it is utilized to relieve subcutaneous pain and swelling.

Huons Lab explained that although equivalent efficacy to the original drug was already confirmed in efficacy tests conducted earlier this year, this recent test secured more accurate and reliable results.

In tests conducted through a domestic contract research organization (CRO), the pharmacokinetics and diffusion efficacy of drugs were analyzed over 28 days after administration in two groups: one group received subcutaneous administration of Mabthera intravenous injection with added HLB3-002, and the other group received subcutaneous administration of Mabthera with the original drug Halozym's hyaluronidase. The results confirmed the equivalence of pharmacokinetics and efficacy between the two groups.

Im Chaeyoung, head of Huons Lab's Bio Research Center, stated, "The non-clinical toxicity test of the recombinant human hyaluronidase HLB3-002 is progressing smoothly, and clinical trial (IND) application is expected early next year." She added, "We will accelerate clinical trials of HLB3-002 aiming to obtain product approval by the end of 2025."

Huons Lab is making efforts to develop hyaluronidase products by establishing a development department, integrating related departments, and expanding cooperative partners.

This content was produced with the assistance of AI translation services.