Huons Lab, a subsidiary of Huons Global, has secured significant intellectual property rights for its HyDIFFUZE platform, which converts intravenous (IV) antibody therapies to subcutaneous (SC) injections.
On August 31, Huons Lab announced that it has completed domestic patent registration and international patent applications (PCT) for 11 subcutaneous injection formulations of antibody drugs utilizing HyDIFFUZE, which temporarily breaks down hyaluronic acid under the skin to aid in drug diffusion and absorption.
The patents cover major antibodies, including pembrolizumab (Keytruda), bevacizumab (Avastin), obinutuzumab (Gazyva), ramucirumab (Cyramza), donanemab, isunakinumab (Saklisa), durvalumab (Imfinzi), dostarlimab (Opdualag), cetuximab (Erbitux), lisocabtagene maraleucel (Skyhiz), and dupilumab (Dupixent).
In non-clinical pharmacokinetic (PK) tests, the subcutaneous injection group using HyDIFFUZE showed a maximum blood concentration (Cmax) increase of approximately 113% to 170% and an area under the curve (AUC) increase of about 117% to 162% compared to the group that did not use HyDIFFUZE.
The company explained that these results indicate a higher likelihood of effective absorption of antibody drugs administered subcutaneously when using HyDIFFUZE.
In March, Huons Lab presented non-clinical results at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) regarding 11 monoclonal antibodies and three antibody-drug conjugates (ADCs) utilizing HyDIFFUZE.
At that time, it was confirmed that even with a 25% reduction in antibody dosage, drug exposure was similar to that of a high-concentration formulation without HyDIFFUZE. In July, the company also registered a domestic patent for a subcutaneous injection formulation of an ADC based on HyDIFFUZE.
The global biopharmaceutical industry is accelerating the development of technologies to switch from IV to SC injections to enhance patient convenience and reduce the burden on healthcare facilities.
In particular, for antibody drugs that require large-volume administration, effective drug delivery technology that allows the drug to spread smoothly in subcutaneous tissue is essential. Huons Lab plans to apply HyDIFFUZE to a variety of biopharmaceuticals, not limited to specific antibodies.
Huons Lab is expanding its application range beyond antibody drugs to include ADCs and is concurrently working on the commercialization of its independently developed recombinant human hyaluronidase product, HyDizime.
Based on the results of a Phase 1 clinical trial involving 243 healthy adults conducted last December, Huons Lab has applied for product approval for HyDizime from the Ministry of Food and Drug Safety, and the approval review is currently underway.
Im Chae-young, Executive Director of Huons Lab's Bio Research Institute, stated, "This patent registration is significant as it confirms the applicability of HyDIFFUZE to antibody drugs, rather than being limited to specific antibodies, and secures related rights. We will continue to expand the application range to various biopharmaceuticals and strengthen our intellectual property and commercialization foundation."
Meanwhile, the merger efforts between Huons and Huons Lab have been halted. The company explained that this decision was made due to a significant drop in Huons' stock price following the merger announcement, which created a gap between the merger price and the current stock price, as well as financial burdens from exercising stock buyback rights.
* This article has been translated by AI.
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