Huonslab Announces Submission of Biologics License Application for Recombinant Human Hyaluronidase ‘HYDIZYME™' [Yahoo! Finance]
Halozyme Therapeutics, Inc. (HALO)
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Source: Yahoo! Finance
PANGYO, South Korea, December 22, 2025 BUSINESS WIRE Huonslab , a subsidiary of Huons Global (KOSDAQ:084110), has submitted a Biologics License Application (BLA) to the Ministry of Food and Drug Safety for its recombinant human hyaluronidase HYDIZYME™ (Development code: HLB3-002), targeting approval in the second half of 2026. The submission is based on the Pivotal Phase 1 clinical trial results, which enrolled a total of 243 healthy volunteers, confirming safety and tolerability with no serious adverse events. The study was conducted at Konkuk University Medical Center, Seoul National University Hospital, Asan Medical Center, and Chung-Ang University Hospital. HYDIZYME™ is a stand-alone drug product identical in amino acid sequence to HYLENEX ® by Halozyme Therapeutics and is manufactured using Huonslab's proprietary HyDIFFUZE™ technology. Huonslab's development and manufacturing of HYDIZYME™ were conducted through collaboration among subsidiaries of Huons Group, PanGen Biotec
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HALO
Earnings
- 11/3/25 - Beat
HALO
Sec Filings
- 12/19/25 - Form 4
- 12/11/25 - Form 4
- 12/9/25 - Form 8-K
- HALO's page on the SEC website