BioNxt Reports "Intention to Grant" Patent Notification from the European Patent Office for Its Oral Cladribine Sublingual Thin-Film as the Multiple Sclerosis Market Shifts Toward Patient-Friendly Therapies
BioNxt Solutions (OTCQB:BNXTF) announced that its German subsidiary received an "Intention to Grant" from the European Patent Office for European patent application no. 23 729 446.7 covering a sublingual cladribine thin-film for multiple sclerosis. Combined with an EAPO "Readiness to Grant," filings could provide potential protection across up to 54 jurisdictions and an addressable population of nearly 1 billion people, subject to national validation and maintenance. The patents claim a cladribine-cyclodextrin complex thin film intended for rapid transmucosal absorption. BioNxt is also pursuing U.S., North America, and Japan filings, completing a large-mass animal bioequivalence study, and planning a human bioequivalence trial while seeking co-development and out-licensing partners.
BioNxt Solutions (OTCQB:BNXTF) ha annunciato che la sua controllata tedesca ha ricevuto una Intenzione di concessione dall'Ufficio Europeo dei Brevetti per la domanda di brevetto europea n. 23 729 446.7 che copre una pellicola sottile sublinguale di cladribina per la sclerosi multipla. Insieme a una Readiness to Grant dell'EAPO, le domande potrebbero offrire protezione potenziale in fino a 54 giurisdizioni e una popolazione accessibile di quasi 1 miliardo di persone, soggetta a convalida e manutenzione nazionali. I brevetti rivendicano un film sottile a base di cladribina-ciclodextrina destinato a un rapido assorbimento transmucoso. BioNxt sta inoltre perseguendo domande negli Stati Uniti, in Nord America e in Giappone, completando uno studio di bioequivalenza su animale di grande massa e pianificando una prova di bioequivalenza nell'uomo, mentre cerca partner per co-sviluppo e licensing esterno.
BioNxt Solutions (OTCQB:BNXTF) anunció que su filial alemana recibió una Intención de Concesión de la Oficina Europea de Patentes para la solicitud de patente europea n° 23 729 446.7 que cubre una película delgada sublingual de cladribina para la esclerosis múltiple. Combinada con una Readiness to Grant de la EAPO, las presentaciones podrían proporcionar protección potencial en hasta 54 jurisdicciones y una población alcanzable de casi 1.000 millones de personas, sujeta a validación y mantenimiento nacionales. Las patentes reclaman una película delgada de cladribina-Complejo con ciclodextrina destinada a una rápida absorción transmucosa. BioNxt también está persiguiendo presentaciones en Estados Unidos, Norteamérica y Japón, completando un estudio de bioequivalencia en animales de gran masa y planificando un ensayo de bioequivalencia en humanos, mientras busca socios para co-desarrollo y licensing externo.
BioNxt Solutions (OTCQB:BNXTF)는 독일 자회사가 유럽 특허청으로부터 Intention to Grant를 받았다고 발표했습니다. 이는 유럽 특허 출원 번호 23 729 446.7을 다루며 설하 집중형 클라드리빈 박막을 대상으로 하는 다발성 경화증용 특허입니다. EAPO의 Readiness to Grant와 결합하면 최대 54개 관할권에서의 보호 가능성과 거의 10억 명에 달하는 주소 가능 인구를 제공할 수 있으며, 이는 국가별 확인 및 유지에 달려 있습니다. 특허는 빠른 점막 흡수를 목표로 한 클라드리빈-사이클로덱스트린 복합체 박막를 청구합니다. BioNxt는 또한 미국, 북미, 일본의 출원을 추구하고 있으며, 대용량 동물 생물학적 동등성 연구를 완료하고 인간 생물학적 동등성 시험을 계획하는 한편 공동 개발 및 라이선스 아웃 파트너를 모색하고 있습니다.
BioNxt Solutions (OTCQB:BNXTF) a annoncé que sa filiale allemande a reçu une Intention de Grant de l'Office européen des brevets pour la demande de brevet européen n° 23 729 446.7 couvrant un film sous-lingual à base de cladribine pour la sclérose en plaques. Associée à une Readiness to Grant de l’EAPO, les dépôts pourraient offrir une protection potentielle dans jusqu'à 54 juridictions et une population adressable de près d'un milliard de personnes, sous réserve de validation et de maintenance nationales. Les brevets revendiquent un film mince à base de cladribine-cyclodextrine destiné à une absorption transmucosa rapide. BioNxt poursuit également des dépôts aux États‑Unis, en Amérique du Nord et au Japon, en complétant une étude de biodisponibilité sur des animaux de masse et en prévoyant un essai d’équivalence biologique chez l’homme, tout en recherchant des partenaires de co-développement et de licensing.
BioNxt Solutions (OTCQB:BNXTF) gab bekannt, dass ihre deutsche Tochtergesellschaft eine Intention to Grant vom Europäischen Patentamt für die europäische Patentanmeldung Nr. 23 729 446.7 erhalten hat, die einen sublingualen Cladribin-Schmelfilm für Multiples Sklerose abdeckt. In Verbindung mit einer Readiness to Grant der EAPO könnten die Einreichungen potenziellen Schutz in bis zu 54 Jurisdiktionen und einer adressierbaren Bevölkerung von fast eineinhalb Milliarden Menschen bieten, vorbehaltlich nationaler Validierung und Wartung. Die Patente beanspruchen einen Cladribin-Cyclodextrin-Komplex-Schmelfilm, der für eine schnelle transmukosale Absorption bestimmt ist. BioNxt verfolgt zudem Anmeldungen in den USA, Nordamerika und Japan, führt eine Bioäquivalenzstudie an großen Tieren durch und plant einen menschlichen Bioäquivalenztest, während sie Partner für Co-Development und Out-Lizenzierung sucht.
BioNxt Solutions (OTCQB:BNXTF) أعلنت أن الشركة التابعة لها في ألمانيا تلقت من مكتب البراءات الأوروبي نية المنح لـ طلب البراءة الأوروبي رقم 23 729 446.7 الذي يغطي طبقة فيلمية سطحية فموية من الكلادريبين لمرض التصلب المتعدد. وبالإضافة إلى Readiness to Grant من EAPO، قد توفر الطلبات حماية محتملة في حتى 54 ولاية قضائية وسكاناً قابلاً للوصول يقارب مليار شخص، رهناً بالتصديق الوطني والصيانة. تدّعي براءات الاختراع طبقة فيلمية دقيقة من مركب الكلادريبين-سيليلوديكسترين مُعدة لامتصاص عبر الغشاء المخاطي بسرعة. تسعى BioNxt أيضاً إلى تقديم طلبات في الولايات المتحدة، أمريكا الشمالية واليابان، وتكمل دراسة التوافقة الحيوية الحيوانية كبيرة الكتلة وتخطط لتجربة توافر بيولوجي بشري، في حين تبحث عن شركاء للتطوير المشترك والتراخيص الخارجية.
- Intention to Grant received from the European Patent Office
- Potential patent protection across up to 54 jurisdictions
- Addressable population of nearly 1 billion people in covered regions
- Lead candidate BNT23001 targets patient-friendly sublingual delivery
- EPO "Intention to Grant" is not a final patent; subject to validation
- Commercialization depends on national validation and maintenance requirements
- BNT23001 remains pre‑human; only a large‑mass animal study is complete
- Regulatory and partnering outcomes required before market entry
VANCOUVER, BC / ACCESS Newswire / November 4, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT) is pleased to announce that its wholly owned German subsidiary, Vektor Pharma TF GmbH, has received an "Intention to Grant" notification from the European Patent Office (EPO) for European patent application no. 23 729 446.7, covering a sublingual, orally dispersible thin-film formulation of cladribine for the treatment of multiple sclerosis (MS) and related neurodegenerative diseases.
Covering an addressable population of nearly 1 billion people across Europe, Eurasia, and associated validation states, BioNxt's expanding patent portfolio secures access to some of the world's largest and most advanced pharmaceutical markets. The EPO "Intention to Grant" for European patent application no. 23 729 446.7 complements the Company's previously announced "Readiness to Grant" from the Eurasian Patent Organization (EAPO) for Eurasian patent application no. 202590051. Together, these patent filings provide potential protection across up to 54 jurisdictions - including all EPO contracting, validation, and extension states, plus the eight EAPO member countries - subject to national validation and maintenance. This extensive geographic and population coverage strengthens BioNxt's global leadership in oral and transmucosal drug delivery and supports the commercialization strategy for BNT23001, the Company's lead multiple sclerosis candidate.
Expanded IP protection across Europe and Eurasia
The patents protect BioNxt's proprietary transmucosal cladribine delivery composition in the form of a sublingual thin film comprising a cladribine-cyclodextrin complex and hydrophilic polymers such as starch and pullulan. This formulation enables rapid absorption through the oral mucosa, which may enhance bioavailability, tolerability, and patient adherence versus tablets or injectables. BioNxt is expanding its IP portfolio through additional filings, including a U.S. fast-track application, as well as filings in North America, Japan, and other regions to broaden its global patent coverage.
Strong market opportunity: Europe's MS market moves toward oral and patient-friendly therapies
The European MS treatment market is valued at approximately US
MAVENCLAD® (cladribine tablets), approved by the European Medicines Agency and used by more than 100,000 patients globally, according to public disclosures, has established a strong benchmark for oral cladribine therapies. BioNxt's swallow-free, water-free, rapidly dissolving thin-film formulation is designed to simplify administration and further enhance the patient experience, aligning with market trends toward ease of use and self-managed treatment.
"Securing patent protection in both Europe and Eurasia marks a major step forward in our global IP and commercialization strategy," said Hugh Rogers, CEO of BioNxt Solutions Inc. "These patents strengthen our position as a leader in advanced oral drug delivery and support the continued development and partnering of BNT23001."
Next steps and strategic significance
BioNxt continues to advance BNT23001, its lead oral cladribine thin-film candidate, through development and regulatory planning. The Company is completing a large-mass animal bioequivalence study to establish dosing parameters for an upcoming human bioequivalence trial, and is actively pursuing co-development and out-licensing partnerships with both innovator and generic manufacturers seeking patient-friendly formulations of established therapies.
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 www.bionxt.com.
Investor Relations & Media Contact
Hugh Rogers, Co-Founder, CEO and Director
Email: investor.relations@bionxt.com
Phone: +1 604.250.6162
Web: www.bionxt.com
LinkedIn: https://www.linkedin.com/company/bionxt-solutions
Instagram: https://www.instagram.com/bionxt
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"). Such information may include, but is not limited to, statements regarding: the anticipated grant, scope, and timing of European, Eurasian, and other international patent rights; the Company's plans for additional national filings; the development, clinical evaluation, regulatory approval, and commercialization of the Company's Cladribine sublingual thin-film (BNT23001) for multiple sclerosis; the strategic importance of intellectual property protection; the timing, cost, and outcome of preclinical and clinical studies; and the potential application of BioNxt's sublingual thin-film drug delivery platform across additional therapeutic areas.
Forward-looking information is based on management's current expectations, assumptions, estimates, and projections as of the date of this press release. Such statements are subject to inherent risks and uncertainties, many of which are beyond the Company's control, that could cause actual results, performance, or achievements to differ materially from those expressed or implied. These risks and uncertainties include, but are not limited to: outcomes of patent examination and prosecution processes; changes in regulatory requirements or legal frameworks; the results, timing, and costs of preclinical and clinical studies; scalability and reproducibility of manufacturing processes; the availability of strategic partnerships and funding; and broader economic, financial, or geopolitical factors.
Readers are cautioned not to place undue reliance on forward-looking information. Although the Company believes the expectations and assumptions underlying such information are reasonable, there can be no assurance that they will prove to be correct. Except as required under 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.
View the original press release on ACCESS Newswire
FAQ
What did BioNxt (BNXTF) announce on November 4, 2025 regarding patents in Europe?
How many jurisdictions could BioNxt's patents potentially cover for BNXTF's cladribine film?
What is the addressable population for BioNxt's patented cladribine thin-film (BNXTF)?
What development steps did BioNxt say are next for BNT23001 (BNXTF)?
Does the EPO "Intention to Grant" mean immediate market exclusivity for BNXTF?
How does BioNxt position BNT23001 versus existing oral cladribine therapies (BNXTF)?
