Huonslab strengthens HyDIFFUZE IP with completion of US, EU examination request under PCT application

South Korea’s Huonslab Co., a subsidiary of Huons Global Co. and a global leader in recombinant human hyaluronidase-based biologics Sub-Q delivery, announced on Monday that it has successfully completed patent filling and examination requests for its recombinant human hyaluronidase in both US and EU, based on its 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 of PCT application of HyDIFFUZE™(rHuPH20) Process Patent is pivotal to Huonslab IP asset management, enhancing our robust patent estate and endeavor to achieve universal large volume antibody SC delivery based on HyDIFFUZE(rHuPH20),” said Dr. Lee Young Sun, CBO of Huonslab.

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

Huonslab is also developing HLB3-002, a stand-alone rHuPH20 drug product under the brand name of Hydizyme™ in the registration study(N=245) in Korea, anticipating MFDS BLA in 2026.

Huonslab is envisioned and proceeding with US and EU regulatory procedures aiming to achieve FDA and EMA BLA of Hydizyme™ in a timely manner.

Write to Young-Ae Lee at 0ae@hankyung.com