Huonslab reinforces HyDIFFUZE™ (Recombinant human hyaluronidase PH20) Intellectual Property by completing the US and EU Examination Request under PCT application.

Huonslab, Co. Ltd. (https://huonslab.com/layout/eng/home.php?go=main&) S. Korea, a subsidiary of Huons Global (https://huonsglobal.com/eng/home.php) (KOSDAQ:084110) and a global leader in recombinant human hyaluronidase-based biologics Sub-Q delivery, announced on November 11th that it has 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.

Dr. Young Sun Lee, CBO of Huonslab, stated, “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).”

Lee added, “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 hope registration in other major countries to be successfully completed as well.”

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 S. 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.

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