Huonslab, a subsidiary of the Huons Group, presented the results of its formulation conversion study using recombinant human hyaluronidase "HLB3-002" (also known as rHuPH20) during a poster presentation at the 2025 Annual Meeting of the American Association for Cancer Research (AACR 2025), held in Chicago, the U.S. The presentation took place on April 28.

Recognized as the world’s premier cancer research conference, AACR 2025 is taking place in Chicago from April 25 to 30.

Hyaluronidase is an enzyme that acts as a drug diffusion agent by breaking down hyaluronic acid under the skin. Huonslab is developing technology to enable the conversion of intravenous (IV) antibody therapeutics into subcutaneous (SC) formulations using hyaluronidase.

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.

The company expects that the co-formulation of HLB3-002 with infliximab could enable dose reductions and extend dosing intervals for maintenance therapy, potentially improving patient convenience.

HLB3-002 is being developed as a stand-alone, proprietary alternative to Halozyme Therapeutics’ Hylenex. According to Huonslab, HLB3-002 is produced using animal cell culture and the company’s proprietary HyDIFFUZE production technology, resulting in a high-purity product compared to animal-derived hyaluronidase. HLB3-002 shares an identical amino acid sequence with endogenous human hyaluronidase, offering a superior safety profile.

“Through the successful completion of this study, we have reconfirmed the feasibility of developing advanced formulation conversion,” a company official said.

HLB3-002 is undergoing a pivotal phase 1 clinical trial in Korea.

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.