Amicogen Files Patent for New Human Hyaluronidase for Subcutaneous Injection Formulation

Amicogen (CEO Park Cheol), a bio-materials, pharmaceuticals, and healthcare specialist company, announced on the 4th that it has filed a patent related to human hyaluronidase, which is essential for subcutaneous injection (SC) formulations.

The patent is titled “Mutants of recombinant human hyaluronidase showing high activity at neutral pH and their uses.” This patent application marks an important turning point as it initiates the reevaluation of Amicogen’s new growth engine in the high value-added pharmaceutical enzyme business.

Amicogen’s patent technology fundamentally differs from existing patents by using a new human-derived hyaluronidase instead of the commercially available “hyaluronidase PH20” used by the U.S. company Halozyme or the Korean company Alteogen.

Recombinant human hyaluronidase is known for its high convenience, but due to the nature of its mechanism of action, it is an enzyme that shows activity at low pH levels and exhibits very low activity at the biological pH of 7, which limits its improvement and application.

Amicogen’s patent is based on the mechanism of action of human-derived hyaluronidase and involves an improved human-derived hyaluronidase that shows high activity at neutral pH.

Currently, SC formulation technology involves mixing human “hyaluronidase PH20” with biopharmaceuticals and injecting them subcutaneously. The hyaluronidase injected subcutaneously breaks down hyaluronic acid (HA), a high-molecular polymer in subcutaneous tissue, helping drugs such as antibodies penetrate tissues faster and be absorbed into the bloodstream.

Existing biopharmaceuticals were administered via intravenous injection over 2 to 3 hours in hospitals, but subcutaneous formulations can be conveniently administered within 5 minutes at hospitals or at home, significantly improving patient convenience.

The human hyaluronidase used in SC formulations is expected to grow from a market size of $1 billion in 2023 at a compound annual growth rate (CAGR) of 9%, reaching $12 billion by 2036.

Park Cheol, CEO of Amicogen, stated, “As a leading enzyme specialist company in Korea, we were able to quickly design recombinant human hyaluronidase tailored to its intended use based on over 20 years of accumulated enzyme improvement technology and know-how. Amicogen’s improved human-derived hyaluronidase is a differentiated new technology from existing products, and its enzyme sequence is not restricted by existing patents, making it applicable to various SC formulations.”

He added, “Amicogen aims to become a game changer that will shake up the global SC formulation market by undergoing non-clinical and clinical phases within the next three years.”

This content was produced with the assistance of AI translation services.