BioNxt Secures Final Patent Grant from the Eurasian Patent Organization for Sublingual Cladribine Platform
BioNxt (OTCQB:BNXTF) announced that the Eurasian Patent Organization granted Patent No. 051510 (issued November 14, 2025) covering sublingual delivery of anticancer drugs, including BioNxt's lead candidate BNT23001, a sublingual cladribine thin-film for multiple sclerosis. The patent provides protection across all eight EAPO member states—Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, and Turkmenistan—covering a combined population of more than 200 million, and is valid through June 14, 2043.
BioNxt said an ongoing two-week large-mass animal bioequivalence study is underway and a human bioequivalence study is planned. The company noted an EPO Intention to Grant and ongoing Track One U.S. priority filing plus nationalization efforts in Canada, Australia, New Zealand, and Japan as part of its global IP and commercialization strategy.
BioNxt (OTCQB:BNXTF) ha annunciato che l'Organizzazione Eurasiana della Patente ha concesso la Patente No. 051510 (rilasciata il 14 novembre 2025) che copre la somministrazione sottolinguale di farmaci anticancro, inclusa la candidata principale di BioNxt BNT23001, una sottolinguale pellicola di cladribina per la sclerosi multipla. La patente offre protezione in tutti e otto gli Stati membri dell'EAPO — Armenia, Azerbaigian, Bielorussia, Kazakistan, Kirghizistan, Russia, Tajikistan e Turkmenistan — che coprono una popolazione combinata di più di 200 milioni, ed è valida fino al 14 giugno 2043.
BioNxt ha detto che è in corso uno studio di bioequivalenza animale su larga massa di due settimane e uno studio di bioequivalenza sull'uomo è pianificato. L'azienda ha notato una Intenzione dell'EPO di concedere e un ongoing Track One US priority filing oltre a sforzi di nazionalizzazione in Canada, Australia, Nuova Zelanda e Giappone come parte della sua strategia globale di IP e commercializzazione.
BioNxt (OTCQB:BNXTF) anunció que la Organización de Patentes Euroasiática concedió la Patente N° 051510 (emitida el 14 de noviembre de 2025) que cubre la administración sublingual de fármacos anticancerígenos, incluida la candidata principal de BioNxt BNT23001, una película delgada de cladribina para la esclerosis múltiple. La patente ofrece protección en los ocho Estados miembros de la EAPO — Armenia, Azerbaiyán, Bielorrusia, Kazajistán, Kirguistán, Rusia, Tayikistán y Turkmenistán — que cubren una población combinada de más de 200 millones, y es válida hasta el 14 de junio de 2043.
BioNxt dijo que se está llevando a cabo un estudio de bioequivalencia en animales de gran tamaño de dos semanas y se planea un estudio de bioequivalencia en humanos. La empresa señaló una Intención de la EPO de otorgar y un proceso de prioridad Track One en EE. UU. en curso, además de esfuerzos de nacionalización en Canadá, Australia, Nueva Zelanda y Japón como parte de su estrategia global de IP y comercialización.
BioNxt (OTCQB:BNXTF)은 Eurasian 특허 기구가 특허 No. 051510을 부여했다고 발표했습니다(발급일 2025년 11월 14일). 이는 항암제의 설하 투여를 다루며 BioNxt의 주 후보물질 BNT23001, 다클리드리빈의 설하용 얇은 필름으로 다발성 경화증에 적용됩니다. 이 특허는 EAPO 8개 회원국인 아르메니아, 아제르바이잔, 벨라루스, 카자흐스탄, 키르기스스탄, 러시아, 타지키스탄, 투르크메니스탄을 포괄하며 누적 인구는 200백만 명 이상이고 2043년 6월 14일까지 유효합니다.
BioNxt는 2주 간 대량 동물 생체 내 약동학(BEI) 연구가 진행 중이며 인간 대상 BEI 연구가 계획되어 있다고 밝혔습니다. 또한 회사는 EPO의 부여 의향과 미국 Track One 우선 순위 출원, 캐나다, 호주, 뉴질랜드, 일본의 국유화 노력이 글로벌 IP 및 상업화 전략의 일부라고 언급했습니다.
BioNxt (OTCQB:BNXTF) a annoncé que l'Organisation européenne des brevets a accordé le Brevet n° 051510 (émis le 14 novembre 2025) couvrant l'administration sublinguale de médicaments anticancéreux, y compris le principal candidat de BioNxt BNT23001, un film mince sublingual à la cladribine pour la sclérose en plaques. Le brevet couvre les huit États membres de l'EAPO — Arménie, Azerbaïdjan, Biélorussie, Kazakhstan, Kirghizistan, Russie, Tadjikistan et Turkménistan — pour une population combinée de plus de 200 millions de personnes et est valable jusqu'au 14 juin 2043.
BioNxt a indiqué qu'une étude d'équivalence biologique animale à grande échelle de deux semaines est en cours et qu'une étude d'équivalence biologique chez l'homme est planifiée. L'entreprise a noté une Intention de l'EPO à accorder et un dépôt prioritaire Track One américain en cours, ainsi que des efforts de nationalisation au Canada, en Australie, en Nouvelle-Zélande et au Japon dans le cadre de sa stratégie mondiale en IP et en commercialisation.
BioNxt (OTCQB:BNXTF) gab bekannt, dass die Eurasian Patent Organization die Patent NR. 051510 (ausgestellt am 14. November 2025) erteilt hat, die sublinguale Abgabe von Krebstherapeutika abdeckt, einschließlich BioNxts führendem Kandidaten BNT23001, einem sublingualen Cladribin-Dünnfilm für Multiple Sklerose. Die Patentschutz gilt in allen acht EAPO-Mitgliedstaaten — Armenien, Aserbaidschan, Weißrussland, Kasachstan, Kirgistan, Russland, Tadschikistan und Turkmenistan — und deckt eine kombinierte Bevölkerung von mehr als 200 Millionen ab und ist gültig bis zum 14. Juni 2043.
BioNxt sagte, dass eine laufende zweiwöchige großmaßstäbliche Tier-BEI-Studie im Gange ist und eine BE-Studie am Menschen geplant ist. Das Unternehmen wies auf eine EPO-Absicht zur Gewährung hin und auf eine laufende Track-One-US-Prioritätsanmeldung sowie Nationalisierung in Kanada, Australien, Neuseeland und Japan im Rahmen seiner globalen IP- und Vermarktungsstrategie hin.
BioNxt (OTCQB:BNXTF) أعلنت أن Organization eurasian des brevets منحت براءة اختراع رقم 051510 (الصادرة في 14 نوفمبر 2025) تغطي التوصيل تحت اللسان للأدوية المضادة للسرطان، بما في ذلك المرشح الرائد لـ BioNxt BNT23001، فيلم رقيق من Cladribine تحت اللسان لمرض التصلب المتعدد. توفر البراءة حماية في جميع الدول الأعضاء الثمانية في EAPO — أرمينيا وأذربيجان وبيلاروسيا وكازاخستان وقيرغيزستان وروسيا وتاجيكستان وتركمانستان — وتغطي تجمع سكانى أكثر من 200 مليون وشاملة صالحة حتى 14 يونيو 2043.
وقالت BioNxt إن هناك دراسة حركية دوائية حيوية في الحيوانات كبيرة الحجم لمدة أسبوعين جارية وأن دراسة حركية دوائية بشرية مخطط لها. وأشارت الشركة إلى وجود نية EPO بمنح وإجراء أولوية Track One في الولايات المتحدة جاري، إضافة إلى جهود التوطين في كندا وأستراليا ونيوزيلندا واليابان كجزء من استراتيجيتها العالمية للملكية الفكرية والتسويق.
- EAPO patent granted (No. 051510) issued November 14, 2025
- Patent protection across 8 EAPO states covering >200 million people
- Patent term valid through June 14, 2043
- EPO issued an Intention to Grant confirming novelty and inventive step
- Two-week large-mass animal bioequivalence study currently underway
- Key value drivers depend on upcoming animal and human study results
- Global protection remains incomplete; nationalization efforts in multiple jurisdictions ongoing
VANCOUVER, BC / ACCESS Newswire / November 20, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT), a bioscience innovator specializing in advanced drug delivery systems, is pleased to announce that the Eurasian Patent Organization (EAPO) has officially granted Patent No. 051510 (issued November 14, 2025).
The patent covers the sublingual delivery of anticancer drugs for the treatment of autoimmune and neurodegenerative diseases, including BioNxt's lead product candidate BNT23001, a sublingual thin-film formulation of cladribine for multiple sclerosis (MS). The patent grant provides protection across all eight EAPO member states (Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, and Turkmenistan) representing a combined population of more than 200 million people. The patent is valid through June 14, 2043.
A Key Milestone for BioNxt's Global IP Strategy
"The Eurasian patent grant marks a major milestone in our value creation and commercialization strategy," said Hugh Rogers, CEO of BioNxt. "This is BioNxt's first national-level patent and it arrives at a pivotal time, with our two-week large-mass animal bioequivalence study currently underway. We expect meaningful catalysts in the coming weeks and months, including additional national patent grants, results from the animal study, and the launch of our human bioequivalence study. We are confident that these milestones will accelerate ongoing discussions with potential regional and global licencing partners."
Expanding Global Patent Coverage
BioNxt continues to advance patent nationalization across key global pharmaceutical markets, including the European Union, where the European Patent Office (EPO) has issued an Intention to Grant and confirmed novelty, inventive step, and industrial applicability. In the United States, a Track One priority filing is underway, while parallel nationalization efforts progress in Canada, Australia, New Zealand, and Japan. Together, these regions represent some of the world's largest and most advanced pharmaceutical markets and form the foundation for BioNxt's commercialization and partnering initiatives.
About BioNxt Solutions Inc.
BioNxt Solutions Inc. is a bioscience innovator focused on next-generation drug delivery technologies, diagnostic screening systems, and active pharmaceutical ingredient development. The Company's proprietary platforms-Sublingual (Thin-Film), Transdermal (Skin Patch), and Oral (Enteric-Coated Tablets)-target key therapeutic areas, including autoimmune diseases, neurological disorders, and longevity.
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: +1 778.598.2698
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 statements within the meaning of applicable securities laws, including statements regarding the development, testing, regulatory approval, and commercialization of BioNxt's sublingual drug products, as well as projected milestones, anticipated partnerships, and potential market opportunities. Forward-looking statements are inherently subject to significant risks, uncertainties, and assumptions, many of which are beyond BioNxt's control. Factors that could cause actual results to differ materially include, but are not limited to, delays in regulatory approvals, negative outcomes from clinical trials, changes in market demand, fluctuations in funding availability, or disruptions in supply chains. Readers are cautioned not to place undue reliance on these forward-looking statements, as actual results may differ materially from those expressed or implied. BioNxt undertakes no obligation to update or revise forward-looking statements, except as required by law. Factors that could cause actual results to differ materially from those projected include changes in market demand, regulatory developments, delays in clinical trials, fluctuations in financing availability, supply chain disruptions, and unforeseen competitive pressures.
SOURCE: BioNxt Solutions Inc.
View the original press release on ACCESS Newswire
FAQ
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