Amicogen, 16 Trillion Growth Prospect 'Next-Generation Human Hyaluronidase' Begins Preclinical

[Financial News]  Bio-material and pharmaceutical healthcare specialist Amicogen announced on the 14th that it has begun preclinical trials to verify the technology and applicability of its independently developed new human hyaluronidase ((Hyaluronidase). Through this trial, Amicogen will enter the execution stage for the commercialization of high-functionality enzymes for subcutaneous injection (SC) formulations.
This preclinical trial is based on Amicogen's proprietary enzyme technology and is based on a new human hyaluronidase derived from the skin, differentiated in both structure and sequence from the existing commercialized PH20 series enzymes. In particular, it has been evaluated to have technically overcome the limitations of existing products by simultaneously implementing high activity, excellent thermal stability, and low immunogenicity in a neutral pH environment (pH 7).
The current global SC formulation pharmaceutical market is attracting attention as a next-generation formulation technology that can replace intravenous (IV) formulations, and hyaluronidase is considered a key component material for SC formulations. This enzyme plays a role in promoting drug absorption by increasing tissue permeability through the degradation of hyaluronic acid (HA), thereby improving both patient convenience and drug efficiency.
However, currently commercialized products, especially those based on PH20 from Company H in the United States, have limitations in repeated dosing or high-dose applications due to issues such as immunogenicity induction, low thermal stability, and dosage limitations. In addition, the global patent network related to PH20 is intricately intertwined, and attempts to enter the market with subsequent technologies have faced patent disputes for years.
In contrast, Amicogen has built an independent technology platform based on freedom-to-operate (FTO) by discovering and improving new human enzymes derived from the skin without using existing PH20 series enzymes at all. The enzyme completed a domestic patent application in April 2025 (application number 10-2025-0043723), and plans to secure long-term exclusive rights by expanding the global patent portfolio for 3-5 new sequences in the future.
According to market research firm Research Nester, the global hyaluronidase market is expected to grow from approximately $1.07 billion (approximately 1.46 trillion won) in 2024 to approximately $12 billion (approximately 16.25 trillion won) by 2036, with an average annual growth rate of 9%.
Amicogen plans to fully commercialize its hyaluronidase-based business through follow-up strategy design for preclinical and clinical development, global technology transfer and CDMO business development, and SC formulation platform construction, taking this preclinical trial initiation as an opportunity. In addition, it aims to provide a complete solution in the global market by securing productivity and quality competitiveness through linkage with its own media and resin business.
Park Cheol, CEO of Amicogen, said, “This preclinical test is the first gateway to verify the differentiated technology of the newly developed hyaluronidase,” adding, “We will secure scientific data that can prove safety and efficacy, enter the full-fledged preclinical and clinical stages, and actively pursue various commercialization strategies such as global technology transfer and joint development.”





kakim@fnnews.com Kim Kyung-ah Reporter