Huwons Global's subsidiary Huwons Lab is challenging the formulation change platform business that converts intravenous (IV) injections to subcutaneous (SC) injections. The plan is to penetrate the market established by the stronghold of American Halozyme Therapeutics and domestic Alteogen. Huwons Lab is forecasting technology exports of its own platform 'High Diffuse' and entry into the pain relief market based on it.
According to the pharmaceutical and bio industry on the 6th, Huwons Lab is focusing on promoting the performance of High Diffuse, a human hyaluronidase-based SC formulation change platform.
Human hyaluronidase is a substance (enzyme) that breaks down hyaluronic acid, which exists in a sticky mesh structure in the skin or tissues, enhancing the penetration and absorption of drugs. Several companies have attempted to enhance its efficiency by incorporating genetic recombination technology into the human hyaluronidase present in vivo. As a result, it has become possible to change IV-administered biopharmaceuticals, which require hours of administration in hospitals, to subcutaneous injections that can be administered in a few minutes.
On the 4th, Huwons Lab announced research results at the 'American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting' held in Colorado, USA, showing that High Diffuse demonstrated sufficient performance in changing biopharmaceuticals such as antibodies and antibody-drug conjugates (ADCs) to SC formulations.
According to Huwons Lab, after applying High Diffuse to 11 types of monoclonal antibodies and 3 types of ADCs and comparing them with existing IV formulations, the High Diffuse applied group showed an increase in drug exposure and maximum blood drug concentration by 116-162% and 113-170%, respectively, compared to the control group. This means that changing to an SC formulation using High Diffuse significantly increases the drug delivery rate compared to the IV formulation. The company plans to establish a technology export strategy for formulation changes, similar to leading companies.
The SC formulation change platform, which can enhance dosing convenience, is expected to continuously generate demand. New drugs based on evolved modalities (treatment approaches) such as multi-antibodies from antibodies and targeted protein degraders (TPDs) from ADCs are being steadily developed, and as these drugs secure marketability, the need for SC formulation changes will inevitably increase.
At this point, only two companies have secured a verified human hyaluronidase-based formulation change platform: American Halozyme and domestic Alteogen. Halozyme launched its related platform 'Enhance' in the late 2000s, while Alteogen completed 'Hybrozyme' about ten years later at the end of 2019.
Since then, 'Enhance' has been used for formulation changes of over ten blockbuster drugs, including Janssen's multiple myeloma treatment 'Darzalex' and Roche's immuno-oncology drug 'Tecentriq'. Alteogen's Hybrozyme has also been recognized for its value by successfully changing the SC formulation of the immuno-oncology drug 'Keytruda'. The SC formulation of Keytruda, 'Keytruda Qurex', was approved in September and November of last year in the United States and the European Union (EU), respectively.
In contrast, there are obstacles to the global commercialization of the latecomer platform High Diffuse. Unlike Alteogen's Hybrozyme, the nucleotide sequence of High Diffuse is known to be identical to Enhance. The commercialization of High Diffuse is determined by the expiration of Halozyme's patent. In the United States and EU, the patent for Enhance has been extended to between 2027 and 2029, but in Korea, the patent expired in March of last year.
In this regard, a representative from the antibody drug development industry critically evaluated, "As long as there is a platform without patent issues, it will be difficult for large-scale technology exports through High Diffuse to materialize."
In response, a representative from Huwons Lab stated, "We expect that High Diffuse can also be utilized for the SC development of next-generation modalities," and added, "We plan to continue research and development to expand the application range of this technology." Huwons Lab expects that business opportunities will increase from the time when related global patents expire, as Enhance occupies 85% of the formulation change platform market.
Human hyaluronidase is being used in various applications, from correction in cosmetic procedures to treatment of pain or swelling. It is known that when human hyaluronidase is added along with steroids during administration in orthopedics or anesthesiology, it can enhance drug absorption and reduce swelling. It can also be used in correction procedures after fat breakdown or filler use.
Halozyme has already launched 'Hyaluronic' for subcutaneous injection or anesthesia to increase penetration and relieve pain, dominating the global market. Alteogen received approval for 'Tergase' for the same purpose in 2024. Alteogen has set a goal of generating annual sales of 100 billion won from Tergase both domestically and internationally by 2030.
Huwons Lab is also attempting to enter the market in a similar manner. The company applied for product approval for 'High Dizime', a human hyaluronidase-based cosmetic procedure aid and pain reliever, in December last year. It aims to obtain product approval in the second half of this year.
Huwons Lab stated, "High Dizime has confirmed equivalence with leading products and has a production system that enhances stability with over 99% high purity," adding, "The relevant review results will be released within the year."
