Huons Lab "Human Hyaluronidase Confirms Drug Diffusion Efficacy Compared to Original"

[Asia Economy Reporter Myunghwan Lee] Huons Lab announced on the 21st that it recently manufactured the recombinant human hyaluronidase 'HLB3-002' under development at the same concentration as Halozyme's hyaluronidase enzyme-containing antibody drug and conducted a comparative test, confirming that it has similar drug diffusion efficacy.

Hyaluronidase directly breaks down hyaluronic acid present subcutaneously in the human body, relieving pain and swelling. Therefore, it is used as a drug diffusion agent to convert intravenous injection products into subcutaneous injection products. The global market size for hyaluronidase drugs is expected to grow from $700 million in 2018 to $1.4 billion by 2026, showing an average annual growth rate of 8.6%.

In tests conducted through a domestic clinical contract research organization (CRO), Huons Lab confirmed that the group administered intravenous drugs with added HLB3-002 showed faster drug diffusion than the group administered intravenous drugs alone subcutaneously. Furthermore, after manufacturing and comparing with subcutaneous formulation drugs containing hyaluronidase enzyme, similar drug diffusion effects were observed, confirming equivalence in efficacy with Halozyme's hyaluronidase enzyme.

HLB3-002, developed by Huons Lab, is a recombinant human sequence hyaluronidase produced through high-yield animal cell culture and highly purified enzyme, exhibiting high activity and no immune response even at high concentrations, according to the company. By confirming equivalence in efficacy with Halozyme's hyaluronidase enzyme, Huons Lab has acquired the technology to convert intravenous injections into subcutaneous injection formulations.

Huons Lab is preparing to file a patent application for the purification method of human-derived recombinant hyaluronidase using animal cells.

Chae-young Lim, Executive Director of Huons Lab Bio Research Center, stated, "Having confirmed positive results through antibody drug diffusion and pharmacokinetic tests of HLB3-002 produced by animal cell recombinant technology, we will swiftly prepare clinical trials following ongoing non-clinical toxicity tests and launch a human-derived natural hyaluronidase product as a standalone product."

She added, "As a standalone product, it will be utilized in plastic surgery, dermatology, and pain areas. Based on the HLB3-002 technology that can convert intravenous biologic drugs into subcutaneous formulations, we plan to expand its use as a drug diffusion agent and accelerate the development of subcutaneous drugs that improve convenience."

Huons Lab, a subsidiary of Huons Global, is a company developing biopharmaceuticals and biosimilars and is the third in Korea to independently develop a biosimilar of Prolia.