BioNxt Completes "Fast-Track" US Track One Patent Filing for Sublingual Delivery of Cladribine for the Treatment of Multiple Sclerosis
BioNxt (OTCQB:BNXTF) completed a USPTO Track One priority patent filing for BNT23001, a sublingual thin-film cladribine formulation for multiple sclerosis on October 9, 2025. A USPTO office action is expected within 60–90 days with final disposition targeted in 9–12 months. The filing also covers sublingual products for other neurological autoimmune diseases including myasthenia gravis and lupus nephritis.
Patent nationalization is underway in the EU, US, Canada, Australia, Eurasia, New Zealand, and Japan; the European and Eurasian patent offices issued notices of intention to grant, citing novelty and inventive step.
BioNxt (OTCQB:BNXTF) ha completato una domanda di brevetto prioritario Track One presso l'USPTO per BNT23001, una formulazione sublinguale in film sottile di cladribina per la sclerosi multipla, il 9 ottobre 2025. Si prevede un'azione dell'ufficio USPTO entro 60–90 giorni con una decisione finale prevista entro 9–12 mesi. La domanda copre anche prodotti sublinguali per altre malattie autoimmuni neurologiche, tra cui la miastenia gravis e la nefrite lupica.
La nazionalizzazione dei brevetti è in corso nell'UE, negli Stati Uniti, in Canada, in Australia, in Eurasia, in Nuova Zelanda e in Giappone; gli uffici brevetti europei ed eurasiatici hanno emesso avvisi di intenzione di concedere, citando novità e passo inventivo.
BioNxt (OTCQB:BNXTF) completó una solicitud de patente prioritaria de USPTO Track One para BNT23001, una formulación de cladribina en película delgada sublingual para la esclerosis múltiple, el 9 de octubre de 2025. Se espera una acción de la oficina de USPTO dentro de 60–90 días con una resolución final prevista en 9–12 meses. La solicitud también abarca productos sublinguales para otras enfermedades autoinmunes neurológicas, incluida la miastenia gravis y la nefritis lúpica.
La nacionalización de patentes está en marcha en la UE, EE. UU., Canadá, Australia, Eurasia, Nueva Zelanda y Japón; las oficinas de patentes europeas y eurasiáticas emitieron avisos de intención de conceder, citando novedad y paso inventivo.
BioNxt (OTCQB:BNXTF)는 2025년 10월 9일 USPTO의 Track One 우선 특허 출원을 BNT23001에 대해 완료했습니다. 다국어? 다라? 클라드리빈의 설하용 얇은 필름 제형으로 다발성 경화증용입니다. USPTO 오피스 액션은 60–90일 내에 예상되며 최종 처리는 9–12개월을 목표로 합니다. 출원은 다른 신경계 자가면역 질환에 대한 설하용 제품도 다루며, 중증 근무력증 및 루푸스 신염이 포함됩니다.
EU, 미국, 캐나다, 호주, 유라시아, 뉴질랜드, 일본에서 특허의 국책화가 진행 중이며; 유럽 및 유라시아 특허청은 차별성과 신규성을 근거로 허여 의향서를 발행했습니다.
BioNxt (OTCQB:BNXTF) a finalisé une demande de brevet prioritaire Track One auprès de l'USPTO pour BNT23001, une formulation sublinguale en film mince de cladribine pour la sclérose en plaques, le 9 octobre 2025. Une action de bureau USPTO est attendue dans 60–90 jours avec une décision finale visée dans 9–12 mois. La demande couvre également des produits sublinguaux pour d'autres maladies auto-immunes neurologiques, notamment la myasthénie grave et la néphrite lupique.
La nationalisation des brevets est en cours dans l'UE, les États-Unis, le Canada, l'Australie, l'Eurasie, la Nouvelle-Zélande et le Japon; les offices européens et eurasiatiques des brevets ont émis des avis d'intention de délivrer, citant l'originalité et l'étape inventive.
BioNxt (OTCQB:BNXTF) hat eine USPTO Track-One Prioritätspatentanmeldung für BNT23001 abgeschlossen, eine sublinguale Dünnfilm-Formulierung von Cladribin zur Behandlung von Multipler Sklerose, am 9. Oktober 2025. Eine USPTO-Aktenmaßnahme wird innerhalb von 60–90 Tagen erwartet, mit einer endgültigen Entscheidung, die in 9–12 Monaten angestrebt wird. Die Anmeldung deckt auch sublinguale Produkte für andere neurologische Autoimmunkrankheiten ab, einschließlich Myasthenia gravis und Lupusnephritis.
Die nationale Verbreitung der Patente läuft in der EU, den USA, Kanada, Australien, Eurasien, Neuseeland und Japan; die Europäischen und Eurasian Patent Offices haben Absichtserklärungen zur Erteilung ausgestellt und dabei Neuheit und erfinderische Schritt betont.
BioNxt (OTCQB:BNXTF) أكملت طلب براءة أولوية Track One من USPTO لـ BNT23001، تركيبة سليلية رقيقة من فليم الكلادراتيبين لعلاج التصلب المتعدد في 9 أكتوبر 2025. من المتوقع أن يتم إجراء إجراء من مكتب USPTO خلال 60–90 يوماً مع هدف القرار النهائي خلال 9–12 شهراً. يتضمن الطلب أيضاً منتجات تحت اللسان لأمراض مناعية عصبية أخرى بما في ذلك الوهن العضلي الشديد واعتلال الكلية المرتبط بالذئبة.
التوطين الوطني لبراءات الاختراع جارٍ في الاتحاد الأوروبي والولايات المتحدة وكندا وأستراليا وأوراسيا ونيوزيلندا واليابان؛ أصدرت مكاتب البراءات الأوروبية والإوراسية إشعارات بنية الإجازة، مع الإشارة إلى الحداثة والخطوة الابتكارية.
BioNxt (OTCQB:BNXTF) 于 2025 年 10 月 9 日完成了 USPTO Track One 优先级专利申请，针对 BNT23001，一种用于多发性硬化的舌下薄膜克拉比定制剂。USPTO 办公室行动预计在 60–90 天内作出，最终处置目标在 9–12 个月内。该申请还涵盖用于其他神经自免疾病的舌下制剂，包括重症肌无力和狼疮性肾炎。
专利在欧盟、美国、加拿大、澳大利亚、欧亚大陆、新西兰和日本的国别化正在进行；欧洲和欧亚专利局已发出拟予以授予的通知，指出新颖性与创造性。
- USPTO Track One priority filing completed for BNT23001
- Office action expected within 60–90 days
- Final patent disposition targeted within 9–12 months
- Notices of intention to grant from European and Eurasian patent offices
- Patent not yet granted; final U.S. disposition remains pending for up to 9–12 months
VANCOUVER, BC / ACCESS Newswire / October 9, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT), a bioscience innovator specializing in next-generation drug delivery technologies, today announced that it has completed a Track One priority patent filing with the U.S. Patent and Trademark Office (USPTO) for its proprietary sublingual thin-film cladribine formulation (BNT23001), designed for the treatment of multiple sclerosis (MS). The Track One patent filing also covers sublingual drug products for the treatment of many other neurological autoimmune diseases, including myasthenia gravis and lupus nephritis.
Further to the Company's press release dated August 20, 2025, the Company has completed a "fast-track" priority patent filing application for its flag-ship sublingual thin-film cladribine formulation for multiple sclerosis (MS), under the United States Patent and Trademark Office's (USPTO) Track One Program. A formal office action from the USPTO is expected within 60-90 days and final patent disposition within 9-12 months. This fast-track status represents a strategic opportunity to secure near-term U.S. patent protection and strengthen the Company's IP position ahead of pivotal bioequivalence studies and commercial partnering discussions.
The patent nationalization process is underway in key global markets, including the European Union, the United States, Canada, Australia, Eurasia, New Zealand, and Japan. Both the European Patent Office and the Eurasian Patent Office have issued favorable communications, including notice of intentions to grant. Novelty, inventive step, and industrial applicability were fully accepted and only formal non-material adaptations are required for national filings. This is strong validation of the unique scientific and commercial value of BioNxt's proprietary technology.
BNT23001 is an orally dissolvable thin-film formulation of cladribine, a well-established immunomodulatory compound used for the treatment of MS. Delivered sublingually, the formulation is designed for improved bioavailability, faster onset of action, and enhanced patient compliance, particularly in populations affected by dysphagia or seeking non-invasive alternatives to traditional tablets or injections.
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
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