Hydizyme (recombinant human hyaluronidase PH20) / Huons - LARVOL DELTA

Huonslab said Wednesday that Hydizyme, its self-developed recombinant human hyaluronidase injection, is expected to be approved in the second half of this year. (The Korea Herald) - "The application for Hydizyme followed the results of a Phase 1 clinical trial in Korea, which observed no serious adverse events in 247 participants, as the study met its primary endpoint."

Korea approval • Oncology

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). (The Bio) - "Huonslab, subsidiary of Huons Global has entered the final stage for commercializing recombinant human hyaluronidase, targeting approval in the second half of 2026....The submission is based on the results of a (Pivotal) Phase 1 clinical trial, which enrolled a total of 243 healthy volunteers."

Korea approval • Korea filing • Oncology

A Phase I Study to Evaluate the Safety and Drug Allergy of HLB3-002 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=243 | Completed | Sponsor: Huonslab Co., Ltd. | Recruiting ➔ Completed

Trial completion • Allergy • Immunology

Huonslab Achieves Last-Patient-In (LPI) in Phase 1 Pivotal Study for Recombinant Human Natural Hyaluronidase PH20 (Businesswire) - "Huonslab Co., Ltd...has announced the successful completion of patient enrollment in its pivotal phase 1 clinical trial of Hydizyme (recombinant human natural hyaluronidase PH20; rHuPH20; HLB3-002), marking a significant milestone in the ongoing HLB3-002 development program....Huonslab expects to submit a Biological License Application (BLA) for marketing approval with the MFDS by the second half of this year, pending trial outcomes."

Korea filing • Trial status • Oncology

Huonslab highlights recombinant human hyaluronidase results at AACR 2025 (Korea Biomedical Review) - "In preclinical studies involving rats, Huonslab reported that the administration of a combination of HLB3-002 and infliximab significantly improved the bioavailability of infliximab compared to infliximab administered without HLB3-002....Pharmacokinetic studies using high-concentration infliximab formulations (exceeding 120 mg/mL) with HLB3-002 demonstrated an increase in drug diffusion of over 30 percent. Additionally, increasing the infliximab dosage two to threefold when combined with HLB3-002 notably extended the duration of therapeutic blood concentration....Huonslab plans to apply for marketing approval to the Ministry of Food and Drug Safety (MFDS) in the second half of this year following the trial’s completion."

Filing • Preclinical • Oncology