Regulatory Filings • May 22, 2025
Regulatory Filings
Open in ViewerOpens in native device viewer

Exclusive License Agreement for Canada, Australia, New Zealand, Singapore & Hong-Kong Signed with AFT Pharmaceuticals for XTRAZA™ (Tranexamic Acid Oral Rinse)
Liège, Belgium – May 22, 2025 – 07.00 AM CET –– Regulated Information – Inside information - Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, today announces an exclusive licensing agreement with AFT Pharmaceuticals for XTRAZA, Hyloris' proprietary tranexamic acid oral rinse.
Under the terms of the agreement, AFT will commercialize XTRAZA in Canada, Australia, New Zealand, Singapore and Hong-Kong. In return, Hyloris will receive up to 50% of the gross profits generated, after the deduction of specified marketing expenses. No milestone payments are included in the agreement.
Stijn van Rompay and Thomas Jacobsen co-Chief Executive Officers of Hyloris commented "AFT Pharmaceuticals has demonstrated outstanding growth and success over the years, establishing itself as a trusted partner. We are confident that this collaboration will continue to bring innovative treatments to patients in new markets and look forward to the value it will generate for both parties."
XTRAZA™ is a proprietary oral rinse developed for use in minor surgical procedures to prevent or treat bleedings complications. This formulation is especially beneficial for dental care professionals treating patients on anticoagulant therapies, allowing them to continue their anticoagulant treatments while undergoing scheduled dental procedures.
Tranexamic acid, the active ingredient in XTRAZA™, is an antifibrinolytic agent that has been widely used for decades 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 bleeding.


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, patented portfolio of 22 reformulated and 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 1 high barrier generic product launched in the U.S. and 2 high barrier generic products in development.
Hyloris is based in Liège, Belgium. For more information, visit www.hyloris.com and follow-us on LinkedIn.
AFT Pharmaceuticals is a listed (NZE: AFT) and growing multinational pharmaceutical company that develops, markets, and distributes a broad portfolio of pharmaceutical products across a wide range of therapeutic categories. Its business model focuses on developing and in-licensing patented, branded, and generic products for commercialization. AFT has direct operations in Australia, New Zealand, Singapore, Hong Kong, South Africa, Canada, and the United Kingdom and has out-licensed products to licensees and distributors in over 120 countries worldwide.
Learn more at www.aftpharm.com
*****
For more information, contact Hyloris Pharmaceuticals: Stijn Van Rompay, co-CEO [email protected]
Thomas Jacobsen, co-CEO [email protected] 32 (0)4 346 02 07


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.

Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.