As technology that converts intravenous (IV) biologics into subcutaneous (SC) injections that can be administered in a shorter time draws attention from global drugmakers, market competition is heating up.
Following Alteogen, which secured its position as an "SC platform powerhouse" with technology exports worth trillions of won, traditional drugmaker Huons is also pursuing a global deal, emerging as a variable that could reshape the market.
According to the industry on the 7th, Huons is in talks on a co-development contract to apply its HyDIFFUZE platform to convert an IV formulation into an SC formulation with a global pharmaceutical company. Antibody-drug conjugate (ADC) medicines are currently said to be the leading candidates under review.
Huons, which has grown on a business centered on generic prescription drugs, expanded its portfolio with botulinum toxin and has recently shifted its focus to the bio business, accelerating a transformation of its business structure. At the core of this shift is the HyDIFFUZE platform developed by Huons Lab, a research and development (R&D) subsidiary under Huons Global.
HyDIFFUZE is a technology based on recombinant human-derived hyaluronidase that can convert not only antibody drugs but also ADCs into SC formulations. The company said at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) in March that preclinical results applying HyDIFFUZE to three types of antibodies and ADCs showed absorption efficiency was significantly improved compared with the original substances.
ADCs are anticancer drugs that target and attack only cancer cells and are mostly administered intravenously. While administration typically takes four to five hours, converting to injections into subcutaneous fat in areas such as the abdomen or thigh can reduce the dosing time to around five minutes and enable self-administration by patients. Given their potential to greatly improve patient convenience and in-hospital dosing efficiency, SC conversion platforms are considered a core competitive edge for global drugmakers.
Alteogen is leading current SC conversion technology for ADCs. Based on its Hybrozyme platform using the hyaluronidase ALT-B4, the company is developing an SC formulation of Enhertu, which was co-developed by Japan's Daiichi Sankyo and the United Kingdom's AstraZeneca.
It has signed a total of seven technology export deals with companies including GSK plc in the United Kingdom and Biogen in the United States, and the SC formulation of the world's top-selling drug, the immuno-oncology therapy Keytruda, developed with Merck (MSD) in the United States, has been approved in the United States and Europe.
In addition, several domestic biotechs, including Inventage Lab and Prestige Biopharma, are developing SC platforms, intensifying related competition.
In this landscape, the emergence of Huons is seen as a new variable. The co-development target under discussion is reportedly an ADC candidate that competes with Enhertu. If the SC conversion succeeds, the company could rapidly expand its presence in the market despite being a latecomer.
Since last year, Huons has introduced the HyDIFFUZE platform at major international conferences and events and has held partnership meetings with global pharmaceutical companies, and it is currently pursuing technology exports of its SC conversion platform with multiple companies. Huons Lab sees as a strength that the platform can be applied not only to ADCs but also to various modalities (treatment delivery methods) such as bispecific antibodies and targeted protein degraders (TPD).
A company official said, "The HyDIFFUZE platform can be used not only for antibody and ADC therapies but also for developing subcutaneous formulations of various next-generation biologics," and added, "We will continue discussions on co-development and collaboration with global pharmaceutical companies."
Commercialization of SC drugs developed with the HyDIFFUZE platform is also on the horizon. In December, Huons Lab applied to the Ministery of Food and Drug Safety for approval of the hyaluronidase product HyDIZYME injection. It is a biologic made with the same protein amino acid sequence as Hylenex, a hyaluronidase product from the United States' Halozyme.
Hylenex's patents expired in Korea and Europe in March 2024 and are scheduled to expire in the United States in September 2027. Considering that approval is possible with only Phase 1 clinical data, there is strong expectation of approval within the year.