Huonslab, a subsidiary of Huons Global, announced on the 11th that it remains on track to secure approval for its recombinant human hyaluronidase, HYDIZYME™ Injection.

In December 2025, the company submitted a Biologics License Application (BLA) to the Ministry of Food and Drug Safety for HYDIZYME™ Injection (development code: HLB3-002).

HYDIZYME™ is a stand-alone product with an identical amino acid sequence to HYLENEX®, originally developed by Halozyme Therapeutics. The product is manufactured using Huonslab’s proprietary HyDIFFUZE™ technology.

The BLA submission is supported by data from a pivotal Phase 1 clinical trial conducted in Korea involving 243 healthy volunteers. The study met its primary endpoint, with no serious adverse events reported.

Upon approval, Huonslab plans to commercialize HYDIZYME™ Injection across aesthetics, dermatology, pain management, and edema indications. The company also intends to expand applications of its HyDIFFUZE™ platform to develop drug diffusion agents that enable conversion of intravenous formulations into subcutaneous formulations.

Chae Young Lim, Chief Technology Officer of Huonslab, said the company has not received any requests for supplementary data from the MFDS since filing the BLA in December. “With approval anticipated in the second half of 2026, we are fully preparing for a smooth market launch,” he stated.