BioNxt Solutions Reports Pending Patent Grants in Europe and Eurasia, Strengthening IP Protection for Proprietary Sublingual Cladribine-Based MS Treatment
BioNxt Solutions (OTC:BNXTF) has received positive communications from both the European Patent Office (EPO) and Eurasian Patent Organization (EAPO) regarding its patent applications for a proprietary sublingual Cladribine thin-film formulation. The patents cover the use of chemotherapy drugs in oral dissolvable delivery systems for treating autoimmune neurological diseases.
The company's technology focuses on treating relapsing-remitting multiple sclerosis (RRMS) through a sublingual administration method designed to optimize drug absorption and improve patient compliance. The patent protection extends to the film composition, administration methods, dosage, and manufacturing processes.
BioNxt has also filed patent applications in other major markets including the United States, Canada, Japan, Australia, and New Zealand. The company is preparing for GMP manufacturing and a human bioequivalence clinical study in Europe to support regulatory filings and commercialization.
BioNxt Solutions (OTC:BNXTF) ha ricevuto riscontri positivi sia dall'Ufficio Europeo dei Brevetti (EPO) sia dall'Organizzazione dei Brevetti Eurasiatica (EAPO) riguardo alle sue domande di brevetto per una formulazione proprietaria di Cladribina in film sottolinguale. I brevetti coprono l'uso di farmaci chemioterapici in sistemi di somministrazione orale dissolvibile per il trattamento di malattie neurologiche autoimmuni.
La tecnologia dell'azienda 猫 focalizzata sul trattamento della sclerosi multipla recidivante-remittente (RRMS) tramite un metodo di somministrazione sottolinguale progettato per ottimizzare l'assorbimento del farmaco e migliorare l'aderenza del paziente. La protezione brevettuale riguarda la composizione del film, i metodi di somministrazione, il dosaggio e i processi produttivi.
BioNxt ha inoltre depositato domande di brevetto in altri mercati chiave come Stati Uniti, Canada, Giappone, Australia e Nuova Zelanda. L'azienda si sta preparando per la produzione GMP e per uno studio clinico di bioequivalenza umana in Europa, a supporto delle procedure regolatorie e della commercializzazione.
BioNxt Solutions (OTC:BNXTF) ha recibido comunicaciones positivas tanto de la Oficina Europea de Patentes (EPO) como de la Organizaci贸n de Patentes Euroasi谩tica (EAPO) respecto a sus solicitudes de patente para una formulaci贸n propietaria de Cladribina en pel铆cula sublingual. Las patentes cubren el uso de f谩rmacos quimioterap茅uticos en sistemas de administraci贸n oral disolubles para el tratamiento de enfermedades neurol贸gicas autoinmunes.
La tecnolog铆a de la compa帽铆a se centra en el tratamiento de la esclerosis m煤ltiple remitente-recidivante (RRMS) mediante un m茅todo de administraci贸n sublingual dise帽ado para optimizar la absorci贸n del medicamento y mejorar la adherencia del paciente. La protecci贸n de la patente abarca la composici贸n de la pel铆cula, los m茅todos de administraci贸n, la dosificaci贸n y los procesos de fabricaci贸n.
BioNxt tambi茅n ha presentado solicitudes de patente en otros mercados importantes como Estados Unidos, Canad谩, Jap贸n, Australia y Nueva Zelanda. La compa帽铆a se est谩 preparando para la fabricaci贸n bajo GMP y un estudio cl铆nico de bioequivalencia humana en Europa para apoyar las presentaciones regulatorias y la comercializaci贸n.
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BioNxt Solutions (OTC:BNXTF) a re莽u des retours positifs de l'Office Europ茅en des Brevets (OEB) ainsi que de l'Organisation des Brevets Eurasienne (EAPO) concernant ses demandes de brevet pour une formulation propri茅taire de Cladribine en film sublingual. Les brevets couvrent l'utilisation de m茅dicaments chimioth茅rapeutiques dans des syst猫mes d'administration orale dissolubles pour le traitement des maladies neurologiques auto-immunes.
La technologie de l'entreprise se concentre sur le traitement de la scl茅rose en plaques r茅currente-r茅mittente (RRMS) via une m茅thode d'administration sublinguale con莽ue pour optimiser l'absorption du m茅dicament et am茅liorer l'observance des patients. La protection par brevet s'茅tend 脿 la composition du film, aux m茅thodes d'administration, au dosage et aux proc茅d茅s de fabrication.
BioNxt a 茅galement d茅pos茅 des demandes de brevet sur d'autres march茅s majeurs tels que les 脡tats-Unis, le Canada, le Japon, l'Australie et la Nouvelle-Z茅lande. L'entreprise se pr茅pare 脿 la fabrication GMP et 脿 une 茅tude clinique de bio茅quivalence humaine en Europe afin de soutenir les d茅marches r茅glementaires et la commercialisation.
BioNxt Solutions (OTC:BNXTF) hat positive R眉ckmeldungen sowohl vom Europ盲ischen Patentamt (EPA) als auch von der Eurasischen Patentorganisation (EAPO) bez眉glich seiner Patentanmeldungen f眉r eine propriet盲re sublinguale Cladribin-D眉nnfilmformulierung erhalten. Die Patente decken die Verwendung von Chemotherapeutika in oral aufl枚sbaren Abgabesystemen zur Behandlung von Autoimmun-Neurologischen Erkrankungen ab.
Die Technologie des Unternehmens konzentriert sich auf die Behandlung der schubf枚rmig-remittierenden Multiplen Sklerose (RRMS) durch eine sublinguale Verabreichungsmethode, die darauf ausgelegt ist, die Medikamentenaufnahme zu optimieren und die Patientencompliance zu verbessern. Der Patentschutz umfasst die Filmzusammensetzung, Verabreichungsmethoden, Dosierung und Herstellungsverfahren.
BioNxt hat au脽erdem Patentanmeldungen in weiteren wichtigen M盲rkten wie den Vereinigten Staaten, Kanada, Japan, Australien und Neuseeland eingereicht. Das Unternehmen bereitet sich auf die GMP-Herstellung und eine klinische Bio盲quivalenzstudie am Menschen in Europa vor, um regulatorische Zulassungen und die Kommerzialisierung zu unterst眉tzen.
- Patent applications accepted by both European (EPO) and Eurasian (EAPO) patent offices
- Patent protection covers multiple aspects including composition, methods, and manufacturing
- Expansion of patent protection into major markets including US, Canada, Japan, Australia
- Technology potentially offers improved drug absorption and patient compliance compared to existing treatments
- Clinical trials and GMP manufacturing yet to begin
- Regulatory approvals still pending in all jurisdictions
- Timeline for full patent grants not specified
VANCOUVER, BC / / August 5, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:鈥疊NXT)(OTC PINK:BNXTF)(FSE:BXT), a bioscience company specializing in innovative drug delivery technologies, is pleased to announce significant progress in its global patent portfolio. The Company has received formal communications from both the European Patent Office (EPO) and the Eurasian Patent Organization (EAPO), confirming that the core claims of its patent application covering its proprietary sublingual Cladribine thin-film formulation have been accepted, with full grants anticipated in the near future. The patent further covers all applications of chemotherapy drugs in an oral dissolvable delivery system for the treatment of autoimmune neurological diseases.
Advancing Toward Formal Patent Grant
European Patent Office (EPO): The EPO has issued an Office Action with the intention to grant for BioNxt's key patent application. This confirmation signifies that all core claims have met the European requirements for novelty, inventive step, and industrial applicability. Only minor formal amendments were requested, which the Company has already addressed. The next Office Action is expected within the coming weeks.
Eurasian Patent Organization (EAPO): The EAPO, covering eight member countries across Eastern Europe and Central Asia, has issued a formal notice that BioNxt's patent application has likewise been accepted. Minor language modifications were required and have been promptly submitted. The Company anticipates a full patent grant across all member states in the near term.
Global Patent Strategy and Expansion
BioNxt previously filed an international patent application under the Patent Cooperation Treaty (PCT) to establish a coordinated framework for securing patent protection for its sublingual Cladribine thin-film technology and future products in multiple key markets. The Company has entered the national phase of this application in major pharmaceutical jurisdictions, including the United States, Canada, Japan, Australia, and New Zealand.
These national phase applications are currently progressing through local examination procedures. Patent protection in these regions will support BioNxt's long-term strategy for global commercialization, regulatory alignment, and regional partnership development.
Protecting Innovation in Multiple Sclerosis (MS) Treatment
The patents under review are designed to protect a family of products, including BioNxt's Cladribine-based thin-film formulation, developed for the treatment of relapsing-remitting multiple sclerosis (RRMS). The platform uses sublingual administration to optimize drug absorption, improve patient compliance, and avoid first-pass hepatic metabolism, offering a patient-friendly alternative to injectable or conventional oral therapies.
Patent protections include composition of the sublingual film, methods of administration and dosage, use for treating autoimmune diseases, and scalable manufacturing processes.
"Securing intellectual property rights in both Europe and Eurasia marks a critical step forward for our Cladribine program and sublingual delivery platform," said Hugh Rogers, CEO of BioNxt Solutions. "These patents represent significant commercial value by protecting a high-potential product, enabling regional exclusivity, and enhancing our ability to generate future licensing and partnership revenue."
Next Milestones in Patent Issuance and Product Advancement
BioNxt expects formal grant notices and publication from both the EPO and EAPO shortly. In parallel, the Company is preparing for GMP manufacturing and a human bioequivalence clinical study in Europe to support regulatory filings and commercialization. Further updates will be provided as additional national patent offices complete their evaluations.
About BioNxt Solutions Inc.
BioNxt Solutions Inc. is a bioscience innovator focused on next-generation drug delivery platforms, diagnostic screening systems, and active pharmaceutical ingredient development. Its proprietary platforms include sublingual thin films, transdermal patches, oral tablets, and a new targeted chemotherapy platform designed to deliver cancer drugs directly to tumors while reducing side effects.
With research and development operations in North America and Europe, BioNxt is advancing regulatory approvals and commercialization efforts, primarily focused on European markets. BioNxt is committed to improving healthcare by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide.
BioNxt is listed on the Canadian Securities Exchange: BNXT, OTC Markets: BNXTF and trades in Germany under WKN: A3D1K3. To learn more about BioNxt, please visit .
Investor Relations & Media Contact
Hugh Rogers, Co-Founder, CEO and Director
Email: [email protected]
Phone: +1 780-818-6422
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Cautionary Statement Regarding "Forward-Looking" Information
This press release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable Canadian securities laws (collectively, "forward-looking information"). Forward-looking information includes, but is not limited to, statements regarding the anticipated grant and scope of European and Eurasian patent rights; the Company's plans for additional international patent filings; the development, clinical evaluation, and commercialization of the Company's Cladribine thin-film (BNT23001) for multiple sclerosis; the strategic importance of intellectual property; the timing and outcome of regulatory processes; and the potential expansion of BioNxt's sublingual drug delivery platform to other therapeutic areas.
Forward-looking information is based on management's reasonable assumptions, expectations, estimates, and projections as of the date of this press release. These statements are subject to known and unknown risks, uncertainties, and other factors-many of which are beyond the Company's control-that may cause actual results, performance, or achievements to differ materially from those expressed or implied by such forward-looking information. These risks and uncertainties include, but are not limited to: patent examination and prosecution outcomes; changes in regulatory or legal frameworks; clinical trial results; scalability of manufacturing processes; strategic partnership risks; and broader economic, financial, or geopolitical conditions.
Readers are cautioned not to place undue reliance on forward-looking information. Although the Company believes that the expectations and assumptions reflected in such statements are reasonable, there can be no assurance that they will prove to be correct. Except as required by applicable securities laws, BioNxt undertakes no obligation to update or revise any forward-looking information, whether as a result of new information, future events, or otherwise.
SOURCE: BioNxt Solutions Inc.
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