South Korean biotech Huons Global Co. said on Tuesday that its research and development unit Huonslab has issued a domestic patent claiming a technology of human hyaluronidase PH20 production, which can help speedy drug delivery in cancer treatment.
Dubbed HyDIFFUZE, the recombinant protein plays a key role in converting an intravenous (IV) injectable to a subcutaneous one, facilitating faster administration and absorption of the biologics to maximize therapeutic efficacy.
The recombinant protein is also used to reduce subcutaneous pain, edema and other side effects of dermal filler.
Huonslab will apply for a commercial license from Korea’s Ministry of Food and Drug Safety (MFDS) in June 2025 after completing clinical trials of human hyaluronidase PH20, the company said.
It will expand the use of the recombinant protein as an agent on drug diffusion to accelerate the development of the SC injection with enhanced convenience, the company added.
Huonslab plans to file for the patent in the US, Europe, Australia, Japan, Latin America and China.
The company said it has successfully conducted animal testing in clinical research to compare the efficacy of two formulations. One is HyDIFFUSE added to F. Hoffmann-La Roche AG’s autoimmune disease and cancer treatment MabThera IV and the other is US biotech Halozyme Therapeutics Inc.’s human hyaluronidase PH20 added to MabThera SC.
The clinical trial result has been published in an abstract by the American Society of Clinical Oncology (ASCO) with identical pharmacokinetics and equivalent diffusion efficacy between the two formulations, according to Huonslab.
Huonslab said HyDIFFUSE avoids infringement of Halozyme’s human hyaluronidase PH20 production technology patent registered in the US and Europe. This will help global biotechs develop new drugs or biosimilars for SC administration, the company added.
Halozyme’s patent claiming its recombinant human hyaluronidase enzyme platform (rHuPH20) expired in Europe and Korea in March this year and has been extended until September 23, 2027.
The global hyaluronidase market size was estimated at $909.5 million in 2022 and is anticipated to grow at a compound annual growth rate (CAGR) of 8.4% from 2023 to 2030, according to US market data firm Grand View Research.
Write to Ye-Na Kim at
yena@hankyung.com
Jihyun Kim edited this article.
