Huonslab completes major patent filings for hyaluronidase process in U.S. and EU

Huonslab, a subsidiary of Huons Global and a major player in recombinant human hyaluronidase-based biologics Sub-Q delivery, announced on Nov. 11 that it has completed patent filing and examination requests for its recombinant human hyaluronidase...

The Huonslab Logo [HUONS GLOBAL]

Huonslab, a subsidiary of Huons Global and a major player in recombinant human hyaluronidase-based biologics Sub-Q delivery, announced on Nov. 11 that it has completed patent filing and examination requests for its recombinant human hyaluronidase in both the United States and European Union, based on its patent cooperation treaty (PCT) application.

The production method filed by Huonslab produces high-purity recombinant human hyaluronidase with high yield by expressing it in its complete form and optimizing the purification process, completing the international patent application following domestic registration.

“Filing the PCT application for the HyDIFFUZE Process Patent is pivotal to Huonslab’s IP asset management, enhancing our robust patent estate and our endeavor to achieve universal large-volume antibody SC delivery based on HyDIFFUZE,” said Young Sun Lee, chief business officer at Huonslab.

“We plan to file examination requests in other major markets, including China and Japan, following its submission in the U.S. and Europe. Drawing from the successful registration experience in Korea, we anticipate that registration in other major countries will be successfully completed as well.”

Huonslab is also developing HLB3-002, a stand-alone rHuPH20 drug product under the brand name Hydizyme, currently in a registration study with 245 participants, anticipating MFDS BLA submission in 2026.

Huonslab is advancing U.S. and EU regulatory procedures, aiming for FDA and EMA BLA approval of Hydizyme in a timely manner.

BY KIM YEONSOO [kim.yeonsoo1@joongang.co.kr]