Huonslab eyes H2 approval for hyaluronidase injection Hydizyme

Huonslab said Wednesday that Hydizyme, its self-developed recombinant human hyaluronidase injection, is expected to be approved in the second half of this year.

Huonslab, a research-and-development-focused biotechnology subsidiary of Huons Global, submitted the biologics license application for Hydizyme to the Ministry of Food and Drug Safety in December last year. Hydizyme contains recombinant human hyaluronidase manufactured using Huonslab’s proprietary Hydiffuze technology.

Hydizyme is a stand-alone drug that shares an identical sequence with Hylenex, a fast-acting filler dissolver developed by Halozyme Therapeutics. Hylenex was approved by the United States Food and Drug Administration in 2005.

The application for Hydizyme followed the results of a Phase 1 clinical trial in Korea, which observed no serious adverse events in 247 participants, as the study met its primary endpoint.

Upon regulatory approval, the biotechnology firm said it plans to launch products in aesthetics, dermatology, pain management and edema treatment. The company will also actively leverage its Hydiffuze technology platform to develop drug diffusion agents that can convert intravenous formulations to subcutaneous formulations.

“We have not received a single request for supplementary information from the (Ministry of Food and Drug Safety) regarding the (biologics license application) submitted last December,” said Lim Chae-young, chief technology officer of Huonslab. “Expecting the approval to come in the second half of this year, we will make our best efforts to ensure the smooth launch of Hydizyme injection.”