Huonslab announced on Wednesday that its self-developed recombinant human hyaluronidase injection, Hydizyme, is anticipated to receive regulatory approval in the latter half of the year.
Huonslab, a research and development focused biotechnology subsidiary of Huons Global, submitted the Biologics License Application (BLA) for Hydizyme to the Ministry of Food and Drug Safety (MFDS) in December of the previous year. Hydizyme utilizes Huonslab’s proprietary Hydiffuze technology in the manufacturing of its recombinant human hyaluronidase.
Hydizyme is designed as a stand-alone drug and boasts an identical amino acid sequence to Hylenex, a fast-acting filler dissolving agent developed by Halozyme Therapeutics. Hylenex received approval from the United States Food and Drug Administration (FDA) in 2005.
The application for Hydizyme followed the successful completion of a Phase 1 clinical trial conducted in Korea. The study, which included 247 participants, reported no serious adverse events and successfully met its primary endpoint.
Following regulatory approval, the biotechnology company intends to launch Hydizyme for various applications including aesthetics, dermatology, pain management, and edema treatment. The company also plans to actively utilize its Hydiffuze technology platform to develop innovative drug diffusion agents capable of converting intravenous formulations into subcutaneous formulations.
“We have not received any requests for supplementary information from the MFDS concerning the BLA submitted last December,” stated Lim Chae-young, Chief Technology Officer of Huonslab. “With the expectation of approval in the second half of this year, we are dedicated to ensuring the seamless launch of Hydizyme injection.”
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