Submitted Biologics License Application in December 2025… Aiming for Approval in 2H 2026
[by Jin, Yu Jeong] Huonslab, a subsidiary of Huons Global announced on the February 11 that its recombinant human hyaluronidase ‘HYDIZYME™ Injection’ remains on track for approval.
In December 2025, Huonslab submitted Biologics License Application (BLA) with the Ministry of Food and Drug Safety (MFDS) for its recombinant human hyaluronidase `HYDIZYME™ Injection (Development code: HLB3-002)’.
HYDIZYME™ is a stand-alone drug that shares an identical sequence with HYLENEX®, the original product developed by Halozyme Therapeutics. It contains recombinant human hyaluronidase manufactured using Huonslab’s proprietary HyDIFFUZE™ technology.
The submission for ‘HYDIZYME™ Injection’ was based on the results of a (Pivotal) Phase 1 clinical trial in Korea, which enrolled a total of 243 healthy volunteers. No Serious Adverse Events (SAEs) were observed and the trial met its primary endpoint.
Upon approval, Huonslab plans to launch ‘HYDIZYME™ Injection’ as a stand-alone drug product in aesthetics, dermatology, pain management, and edema treatment. The company also plans to actively leverage its HyDIFFUZE™ technology platform to develop drug diffusion agents which convert intravenous formulations to subcutaneous formulations.
Chief Technology Officer of Huonslab, Chae Young Lim said, “We have not received a single request for supplementary information from the MFDS regarding the BLA submitted last December. Expecting the approval in the second half of this year, we will make best efforts to ensure the smooth launch of HYDIZYME™ Injection.”