[Edaily Reporter Kim Jinsoo ] #Huons Co., Ltd. affiliates have recently been announcing a series of research and development (R&D) achievements, including patent registrations and the recognition of functional ingredients. These achievements span a wide range of areas, from formulation technologies that enhance the convenience of administering biopharmaceuticals to aesthetic materials and functional ingredients for health supplements.

In particular, Huons Global Co., Ltd.’s subsidiaries, Huons Lab and Humedix Co., Ltd., have recently announced intellectual property patent achievements related to biopharmaceutical formulations and aesthetic products, respectively, as they work to secure technological competitiveness. Coupled with the recognition of a functional ingredient developed in-house by Huons N, R&D achievements continue to emerge across the group’s affiliates.

Huons Co., Ltd. Develops ‘Subcutaneous Injection’ Formulation for Antibodies and ADCs… Patents Granted

for

Formulation Conversion Platform

According to the Huons Group on the 19th

,

the most notable recent R&D achievement is

a patent

granted to Huons Co., Ltd. for

a formulation conversion platform

utilizing human-derived hyaluronidase.

Earlier this past July, Huons Co., Ltd. completed the registration of a patent for a subcutaneous (SC) formulation of an antibody-drug conjugate (ADC) utilizing “HyDIFFUZE,” a human-derived hyaluronidase-based platform technology. This patent includes formulation technology for developing SC formulations of ADCs using HyDIFFUZE.

An ADC is a biopharmaceutical that combines an antibody with a therapeutic drug. Noting that currently approved ADCs are administered via intravenous (IV) injection, Huons Co., Ltd. is researching the potential for developing a subcutaneous (SC) formulation that could improve the convenience of administration.

In connection with this patent, Huons Co., Ltd. confirmed that the ADC subcutaneous (SC) formulation incorporating HiDiffuse maintains its physicochemical stability even under high-concentration conditions. In preclinical pharmacokinetic evaluations, the application of HiDiffuse increased the rate of rise in blood concentration at the onset of administration by approximately 1.5 times; compared to an SC formulation without HiDiffuse, drug exposure (AUC) and maximum blood concentration (Cmax) improved by up to 126% and 149%, respectively.

In August, the company completed the registration of domestic patents for 11 antibody drug formulations incorporating HiDiffuse at DaihanPharmaceutical.

Huons Co., Ltd. has secured domestic patents for 11 antibody drug formulations incorporating HiDiffuse, including pembrolizumab, bevacizumab, obinutuzumab, ramucirumab, donanemab, isatuximab, Durvalumab, Dostarlimab, Cetuximab, Risankizumab, and Dupilumab—and evaluated their pharmacokinetic characteristics.

The results of the preclinical pharmacokinetic (PK) evaluation of the subcutaneous (SC) formulation group treated with HiDiffuse showed that, compared to the SC formulation group not treated with HiDiffuse, the maximum plasma concentration (Cmax) for each antibody was approximately 113–170% higher, and the area under the curve (AUC) was approximately 117–162% higher in the HiDiffuse group. This confirmed that applying HiDiffuse to antibody drugs for subcutaneous (SC) administration can improve drug exposure in the body. Huons Co., Ltd. anticipates that HiDiffuse can be applied to the conversion of various antibody drugs to subcutaneous (SC) formulations, not limited to specific antibodies.

Huons Co., Ltd. has completed separate international patent applications (PCT) for 11 types of ADC subcutaneous (SC) formulations and antibody drug formulations, and plans to pursue patent applications in individual foreign countries in the future.

Overall, Huons Co., Ltd.’s research is significant not only because it goes beyond the study of a single new drug candidate but also because it is linked to formulation platform technologies that transform the administration methods of biopharmaceuticals, such as antibodies and ADCs.

Humedix

Co

., Ltd. Secures Aesthetic Patent with PN-HA Combination Technology

Humedix Co., Ltd.(200670)

,

the Huons Co., Ltd. aesthetic specialty company, is also continuing to secure intellectual property rights for materials and formulation technologies in the aesthetic field.

Last June, Humedix Co., Ltd. completed the registration of a Russian patent for the composition and manufacturing method of a composite formulation combining sodium polynucleotide (PN) and hyaluronic acid (HA).

This technology involves the manufacture of a composite formulation that combines high-purity HA with PN, which possesses excellent biocompatibility and skin-regenerating effects. It is characterized by reduced pain during procedures compared to existing PN fillers, thanks to the inclusion of lidocaine, a local anesthetic.

Following the registration of the domestic patent for the PN-HA composite formulation in 2022, the company filed an international application under the Patent Cooperation Treaty (PCT). Since then, patent applications have been filed in 12 countries, including the United States, and examinations are currently underway in each of those countries.

In South Korea, the marketing authorization process for the PN-HA composite formulation is also underway. Humedix Co., Ltd. has completed confirmatory clinical trials and submitted a marketing authorization application, aiming for a launch in the second half of the year, pending the outcome of the authorization process.

Huons Co., Ltd.: Attention on R&D Achievements for Individually Recognized Ingredients

Huons Co., Ltd. announced last July that “Hagocho Extract Powder,” a medicinal plant ingredient developed in-house, was recognized by the Ministry of Food and Drug Safety as an individually recognized ingredient with the functional claim “may help support prostate health.”

Huons Co., Ltd. developed its own “Sagunja Extract Powder” and currently operates a prostate health brand under this name. Following the acquisition of an individually recognized ingredient, Huons Co., Ltd. plans to expand its Namsung health business.

Huons Co., Ltd. is also steadily conducting research and development to create an individually recognized ingredient for reducing body fat. Recently, the company obtained research results on body fat reduction through human clinical trials of “Propionibacterium freundii MJ2” (hereinafter “MJ2 Probiotics”) and the postbiotic “Bifidobacterium longum HN001 heat-treated cultured dried material” (hereinafter “HN001 Postbiotics”), both of which were developed in-house.

Probiotics are live microorganisms that colonize and multiply in the gut to provide beneficial effects, while postbiotics are ingredients containing heat-killed microorganisms and their metabolites, which offer excellent safety and storage stability.

Huons Co., Ltd. conducted separate human clinical trials for each of these ingredients to verify their efficacy. Based on these results, the company has completed applications for individual ingredient approvals for each, claiming the functionality “may help reduce body fat.” The company aims to obtain approval by the end of the year.

Expanding the Scope of R&D Competitiveness Through Intellectual Property Rights

Rather than focusing on a single field, the Huons Co., Ltd. Group’s R&D activities take various forms tailored to the business areas of each affiliate. The results of R&D—including not only new product launches but also intellectual property rights such as patents and the approval of functional ingredients—are accumulating as R&D achievements across each business sector.

Huons Co., Ltd. is conducting R&D on a biopharmaceutical formulation conversion platform; Humedix Co., Ltd. is developing the composition and manufacturing methods for PN-HA combination formulations; and Huons N is researching functional ingredients for health functional foods.

In terms of patents, Huons Co., Ltd. has completed the registration of patents for an ADC SC formulation utilizing Hi-Diffuse and for 11 types of antibody formulations, while Humedix Co., Ltd. has completed the registration of a Russian patent related to PN-HA combination formulations. This momentum is further extended by Huons N’s functional ingredients.

A Huons Co., Ltd. official stated, “Research and development achievements by each affiliate, including patent registrations and the recognition of functional ingredients, are continuing,” adding, “We will continue to enhance our technological competitiveness across various business areas.”