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“Huonslab Completes IND Submission for Recombinant Human Hyaluronidase Drug Delivery Agent"

- "HyDIFFUZE™: Advancing Towards the World`s First Biosimilar(Stand-alone) with Ample Competitive Edge" -

Huonslab, a subsidiary of Huons Global, is accelerating the development of recombinant human hyaluronidase.

Huonslab announced on the 29th that it completed non-clinical toxicity studies on HyDIFFUZE™ (HLB3-002), a recombinant human hyaluronidase currently under development, and applied for an IND to Korea Ministry Food and Drug Safety (Korea MFDS). 

Huonslab conducted all essential non-clinical toxicity assessments mandated for the IND through eminent domestic and international Contract Research Organizations (CROs), ensuring safety across all criteria.

HyDIFFUZE™, which is being developed by Huonslab, features naturally derived recombinant human hyaluronidase and has the same amino acid sequence as Hylenex®, the hyaluronidase of Halozyme, the original drug.

In September of last year, a comparative evaluation was conducted through a domestic CRO organization between MabThera® IV, containing HyDIFFUZE™, and MabThera® SC, the original drug containing Hylenex® administered by subcutaneous injection to animals. The results confirmed the similarity between the two formulations, demonstrating equivalent pharmacokinetics and diffusion efficacy.

Chae-young Lim, the executive director of Bio Research at Huonslab, remarked, "Through our non-clinical stdudies, we`ve established the efficacy and safety of HyDIFFUZE™ .We`ve completed the manufacturing of drug substance and product for clinical trials, and have submitted an IND application to Korea MFDS. He further noted, "The expiration of the patent for Hylenex®, the original product of Halozyme, in Korea and Europe in March this year, with the U.S. patent set to expire in September 2027, marks a significant milestone." Lim continued “Upon the completion of clinical trials for our proprietary product, HyDIFFUZE™, and subsequent product approval by the end of 2025, we expect to secure sufficient global competitiveness” He added, "HyDIFFUZE™ will be utilized as a product in the fields of dermatology, pain management, and edema treatment. Furthermore, we aim to accelerate the development of subcutaneous drug delivery by leveraging our HyDIFFUZE™ platform as a drug diffusion enhancer, thereby expanding its utility and enhancing convenience."

Meanwhile, Huonslab is pioneering the development of the world`s first biosimilar (stand-alone) of Hilenex®, a drug diffusion facilitator that enables the conversion of current intravenous injections to subcutaneous injections.