Drugs / HLB3-002
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06713317 | Dec 2024 → Jun 2025 | — | Huonslab Co., Ltd. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-02-11 | Huonslab Co., Ltd. | Regulatory Huonslab on Track for Recombinant Human Hyaluronidase ‘HYDIZYME™ Injection’ Development huonslab.com ↗
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)’. |
| 2025-12-22 | Huonslab Co., Ltd. | Regulatory Huonslab has submitted the Biologics License Application for Recombinant Human Hyaluronidase ‘HYDIZYME™ Injection’ - Applying HyDIFFUZE™ technology… Aiming for Approval in 2026 - huonslab.com ↗
Huonslab announced on the 22nd that it has filed for Biologics License Application with the Ministry of Food and Drug Safety (MFDS) for its recombinant human hyaluronidase 'HYDIZYME™’ (Development code: HLB3-002). |
| 2025-04-29 | Huonslab Co., Ltd. | Results Huonslab Announced the Results of HLB3-002 Formulation Conversion Study in a Poster Presentation at 2025 AACR huonslab.com ↗
In Huonslab’s preclinical studies involving rats, the administration of a combination of HLB3-002 and infliximab significantly improved the bioavailability of infliximab compared to infliximab without HLB3-002. |
| 2024-08-07 | Huonslab Co., Ltd. | Regulatory Huonslab Receives IND Approval from MFDS to Start Pivotal Clinical Trial for ‘Recombinant Human huonslab.com ↗
Huonslab announced on the 7th that Ministry of Food and Drug Safety (MFDS), S. Korea approved the Investigational New Drug (IND) application for HLB3-002, a recombinant human hyaluronidase. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-02-11 | Huonslab Co., Ltd. | Huonslab on Track for Recombinant Human Hyaluronidase ‘HYDIZYME™ Injection’ Development huonslab.com ↗ |
| 2025-12-22 | Huonslab Co., Ltd. | Huonslab has submitted the Biologics License Application for Recombinant Human Hyaluronidase ‘HYDIZYME™ Injection’ - Applying HyDIFFUZE™ technology… Aiming for Approval in 2026 - huonslab.com ↗ |
| 2025-04-29 | Huonslab Co., Ltd. | Huonslab Announced the Results of HLB3-002 Formulation Conversion Study in a Poster Presentation at 2025 AACR huonslab.com ↗ |
| 2024-08-07 | Huonslab Co., Ltd. | Huonslab Receives IND Approval from MFDS to Start Pivotal Clinical Trial for ‘Recombinant Human huonslab.com ↗ |
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HLB3-002 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06713317 ↗ |