Hyloris Pharmaceuticals SA

M&A Activity • Aug 22, 2025

Hyloris Signs Exclusive Licensing Agreement with Huons Co., Ltd. for XTRAZA™ in South Korea

Huons to Commercialize Innovative Oral Rinse for Anticoagulated Dental Patients Under Exclusive Rights in South Korea

Liège, Belgium – 22 August 2025 – 07:00 CET – Regulated Information – Inside information - Hyloris Pharmaceuticals SA ("Hyloris") (EBR: HYL), a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, today announces that an exclusive license and supply agreement has been signed with Huons Co., Ltd ("Huons") for XTRAZA™. Under the terms of the agreement, Hyloris will exclusively supply XTRAZA in South Korea to Huons.

XTRAZA is a proprietary oral rinse formulated to deliver tranexamic acid - an antifibrinolytic agent directly to the oral cavity. It is intended for use in patients taking anticoagulant therapies (blood thinners) who are undergoing dental procedures with a risk of bleeding, such as tooth extractions. While tranexamic acid has a well-established track record in various dosage forms for minimizing or preventing postoperative bleeding, XTRAZA introduces a novel, localized delivery method optimized to promote effective coagulation during and after dental interventions.

Stijn van Rompay and Thomas Jacobsen, co-Chief Executive Officers of Hyloris, commented: "We believe Huons Co., Ltd. is an ideal partner for licensing XTRAZA in South Korea. Their position as a leading player in the South Korean dental market makes them an outstanding choice. Additionally, their extensive distribution network ensures that products can rapidly reach customers and patients, meeting a wide range of oral care needs. With their proven expertise in dental products, Huons is wellequipped to effectively manage and promote this innovative oral care solution."

South Korea's Dental Market

South Korea's dental market offers a strong opportunity for XTRAZA, supported by significant procedural volumes and a highly developed healthcare infrastructure. In 2022, the country recorded 60.5 million dental procedures, with the dental consumables market valued at USD 2.01 billion in 2023 and projected to reach USD 3.33 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 7.4% 1 . The nation has 35,000 licensed dentists (as of 2024), expected to grow by 1.8-2.4% annually, with 64 dentists per 10,000 people, among the highest ratios globally² .

Dental care is widely utilized in South Korea, with patients averaging more than one outpatient visit annually. Among the elderly - who make up a growing share of dental patients - antithrombotic therapy is common due to age-related cardiovascular conditions. Whereas such therapy was once often paused before procedures, current best practice supports maintaining treatment and controlling bleeding with effective local measures.

¹ https://www.grandviewresearch.com/horizon/outlook/dental-consumables-market/south-korea ² https://www.reportlinker.com/dataset/2b63039beff09b957fc6f1dc1e1dee72784a13b7

About XTRAZA™

XTRAZA is a proprietary oral rinse formulated to deliver tranexamic acid, a well-established antifibrinolytic agent, directly to the oral cavity. It is developed to help manage bleeding complications associated with minor surgical procedures, particularly in patients taking anticoagulant therapies (blood thinners). By enabling continued use of anticoagulants during dental procedures such as tooth extractions or scaling, XTRAZA offers a practical solution for clinicians and patients seeking to avoid the risks associated with therapy interruption.

Tranexamic acid, the active ingredient in XTRAZA, is an antifibrinolytic agent that has been widely used for decades to reduce or prevent postoperative bleeding in patients with bleeding disorders. It is currently administered intravenously to reduce or prevent bleeding in patients at high risk of intraoperative and postoperative hemorrhage (including during general and oral surgeries, such as tooth extractions), particularly in patients with bleeding disorders like hemophilia. Additionally, tranexamic acid is approved in oral tablet form for the treatment of cyclic heavy menstrual bleeding³ .

XTRAZA introduces a novel, localized delivery format, tailored specifically for dental care, to promote effective coagulation at the site of intervention, thus enhancing safety, preserving therapeutic continuity, and improving overall patient experience.

About Hyloris Pharmaceuticals

Hyloris is a specialty biopharma company focused on innovating, reinventing, and optimizing existing medications to address important healthcare needs and deliver relevant improvements for patients, healthcare professionals and payors.

The Company's development strategy primarily focuses on leveraging established regulatory pathways, such as the FDA's 505(b)2 pathway in the U.S or equivalent regulatory frameworks in other regions which are specifically designed for pharmaceuticals for which safety and efficacy of the molecule have already been established. This approach can reduce the clinical burden required for market entry, and significantly shorten the development timelines, leading to reduced costs and risks.

Hyloris has built a broad development portfolio of 26 products, including 23 reformulated and/or repurposed value-added medicines that have the potential to offer significant advantages over existing alternatives. Two products are currently in early phases of commercialization in collaboration with commercial partners: Sotalol IV for the treatment of atrial fibrillation, and Maxigesic® IV, a non-opioid post-operative pain treatment. In addition to its core strategic focus, the Company has 2 high barrier generic products approved in the U.S. and 1 high barrier generic product in development.

Hyloris is based in Liège, Belgium and listed on Euronext Brussels (EBR:HYL).

For more information, visit www.hyloris.com and follow-us on LinkedIn.

About Huons Co., Ltd

Founded in 1965, Huons Co., Ltd. (KOSDAQ: 243070) is a publicly listed and rapidly growing South Korean pharmaceutical company engaged in the development, manufacturing, and distribution of a

³ https://www.ncbi.nlm.nih.gov/books/NBK532909

broad portfolio of healthcare products, including prescription medicines, medical devices, biopharmaceuticals, and wellness solutions. With over 2,200 employees and 12 subsidiaries and affiliates, Huons reported revenue of approximately USD 600 million in 2024.

Huons is a market leader in dental anesthetics in South Korea, holding over 80% domestic market share, with products such as dental needles and injectable solutions exported to over 50 countries. The company maintains a comprehensive distribution infrastructure, uniquely covering both inhospital and outpatient prescription channels, and reaches more than 18,800 dental clinics and 236 hospital-based dental departments nationwide.

As part of Huons Global (KOSDAQ: 084110), the company leverages in-house R&D, strategic inlicensing, and global contract manufacturing to support both branded and generic product lines. Its innovation-driven approach spans key therapeutic areas including cardiovascular, metabolic, ophthalmology, and dermatology, delivering high-quality, patient-centered care across global markets.

Learn more at https://huons.com.

For more information, contact Hyloris Pharmaceuticals: Stijn Van Rompay, co-CEO stijn.vanrompay@hyloris.com

Thomas Jacobsen, co-CEO thomas.jacobsen@hyloris.com

32 (0)4 346 02 07

Disclaimer and forward-looking statements

Hyloris means "high yield, lower risk", which relates to the 505(b)(2) regulatory pathway for product approval on which the Company focuses, but in no way relates or applies to an investment in the Shares.

Certain statements in this press release are "forward-looking statements." These forward-looking statements can be identified using forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. These statements relate to future events or the Company's future financial performance and involve known and unknown risks, uncertainties, and other factors, many of which are beyond the Company's control, that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.

This press release contains information about a product under development and is not intended as a promotional statement. The product mentioned is subject to regulatory approval and is not currently available for sale. Please consult licensed medical professionals for healthcare decisions.