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BioNxt Reports "Readiness to Grant" Patent Notification from the Eurasian Patent Organization

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BioNxt (OTCQB:BNXTF) received a Readiness to Grant notice from the Eurasian Patent Organization for a patent family covering sublingual delivery of anticancer drugs aimed at treating autoimmune neurodegenerative diseases, including BioNxt's lead product BNT23001 (sublingual Cladribine for MS).

The company will pay a publication fee this week to secure formal grant in the EAPO region, which covers 8 countries (Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, Turkmenistan) representing a combined population of >200,000,000. BioNxt is days away from starting a two-week large-mass animal bioequivalence study to set dosing for an upcoming human bioequivalence study, and is pursuing patent nationalization in the EU, US (Track One), Canada, Australia, New Zealand, and Japan.

BioNxt (OTCQB:BNXTF) ha ricevuto una notifica di Readiness to Grant dall'Eurasian Patent Organization per una famiglia di brevetti che copre la sottominister delivery di farmaci anticancro finalizzata al trattamento di malattie neurodegenerative autoimmuni, incluso il prodotto di punta di BioNxt BNT23001 (cladribina sublinguale per la SM).

L'azienda verserà una tassa di pubblicazione questa settimana per assicurare la concessione formale nella regione EAPO, che copre 8 paesi ( Armenia, Azerbaigian, Bielorussia, Kazakistan, Kirghizistan, Russia, Tagikistan, Turkmenistan ) rappresentando una popolazione combinata di >200.000.000. BioNxt è a pochi giorni dall'inizio di uno studio bioequivalente animale su scala di massa di due settimane per definire il dosaggio per un prossimo studio bioequivalente umano, e sta perseguendo la nazionalizzazione del brevetto nell'UE, negli USA (Track One), in Canada, Australia, Nuova Zelanda e Giappone.

BioNxt (OTCQB:BNXTF) recibió una notificación de Readiness to Grant de la Organización de patentes euroasiática (EAPO) para una familia de patentes que cubre la administración sublingual de fármacos anticancerígenos destinada a tratar enfermedades neurodegenerativas autoinmunes, incluido el producto líder de BioNxt BNT23001 (cladribina sublingual para EM).

La empresa pagará una tarifa de publicación esta semana para asegurar la concesión formal en la región de la EAPO, que abarca 8 países (Armenia, Azerbaiyán, Bielorrusia, Kazajistán, Kirguistán, Rusia, Tayikistán, Turkmenistán) representando una población combinada de >200.000.000. BioNxt está a pocos días de iniciar un estudio de bioequivalencia en animales de gran tamaño de dos semanas para definir la dosificación de un próximo estudio de bioequivalencia en humanos, y está buscando la nacionalización de la patente en la UE, EE. UU. (Track One), Canadá, Australia, Nueva Zelanda y Japón.

BioNxt (OTCQB:BNXTF)Readiness to Grant 공지를 유라시아 특허 기구(EAPO)로부터 받아 저하 체내 전달의 항암제에 대한 특허 계열을 포함하고, 자가면역 신경퇴행성 질환 치료를 목표로 하는 클래드리빈(sub lingual) 제제의 선도 품목 BNT23001 (다락드리빈 무아성 제제의 MS용)도 포함됩니다.

회사는 이번 주에 EAPO 지역에서의 공식 허여를 확보하기 위한 게시 비용을 지불할 것이며, 이 지역은 8개국 (아르메니아, 아제르바이잔, 벨로루시, 카자흐스탄, 키르기스스탄, 러시아, 타지키스탄, 투르크메니스탄)를 포함하고 있으며, 합계 인구는 >2억 명에 달합니다. BioNxt는 수일 내로 대규모 동물 바이오동등성 2주 연구를 시작해 향후 인간 대상 바이오동등성 연구의 적정 용량을 설정하려 하고, EU, 미국(Track One), 캐나다, 호주, 뉴질랜드, 일본에서 특허 국수화를 추진 중입니다.

BioNxt (OTCQB:BNXTF) a reçu une notification de Readiness to Grant de l'Organisation asiatique des brevets pour une famille de brevets couvrant la distribution sublinguale de médicaments anticancéreux destinée à traiter les maladies neurodégénératives auto-immunes, y compris le produit phare de BioNxt BNT23001 (cladribine sublinguale pour la SEP).

L'entreprise paiera des frais de publication cette semaine pour sécuriser une concession formelle dans la région de l'EAPO, qui couvre 8 pays (Arménie, Azerbaïdjan, Biélorussie, Kazakhstan, Kirghizistan, Russie, Tadjikistan, Turkménistan) représentant une population combinée de >200.000.000. BioNxt est à quelques jours de commencer une étude d'équivalence biologique animale de grande masse sur deux semaines pour fixer le dosage d'une prochaine étude d'équivalence biologique humaine, et poursuit la nationalisation des brevets dans l'UE, les États-Unis (Track One), le Canada, l'Australie, la Nouvelle-Zélande et le Japon.

BioNxt (OTCQB:BNXTF) erhielt eine Readiness to Grant-Mitteilung von der Eurasian Patent Organization für eine Patentfamilie, die die sublinguale Verabreichung von Krebstherapeutika zur Behandlung von Autoimmun-Neurodegenerativen Erkrankungen abdeckt, einschließlich des Leitprodukts von BioNxt BNT23001 (sublinguale Cladribine bei MS).

Das Unternehmen wird in dieser Woche eine Veröffentlichungsgebühr zahlen, um eine formelle Erteilung in der EAPO-Region zu sichern, die 8 Länder umfasst (Armenien, Aserbaidschan, Belarus, Kasachstan, Kirgisistan, Russland, Tadschikistan, Turkmenistan) und eine kombinierte Bevölkerung von >200.000.000 repräsentiert. BioNxt steht kurz davor, eine zweiwöchige großmaßstäbliche Tier-Bioäquivalenzstudie zu starten, um die Dosierung für eine kommende humane Bioäquivalenzstudie festzulegen, und verfolgt die Patentnationalisierung in der EU, USA (Track One), Kanada, Australien, Neuseeland und Japan.

BioNxt (OTCQB:BNXTF) تلقّت إشعاراً بـجاهزية للمنح من التنظيم الأورآسي للبراءات (EAPO) لعائلة براءات تغطي التوصيل تحت اللسان للأدوية المضادة للسرطان بهدف علاج أمراض أعصاب مناعية ذاتية، بما في ذلك المنتج الرائد لـ BioNxt BNT23001 (كلادريبين تحت اللسان لمرض التصلب المتعدد).

ستدفع الشركة رسم نشر هذا الأسبوع لضمان منحاً رسمياً في منطقة EAPO، والتي تغطي ثمانية دول (أرمينيا، أذربيجان، بيلاروسيا، كازاخستان، قيرغيزستان، روسيا، طاجيكستان، تركمنستان)، وتُمثل مجموعاً سكانياً قدره >200,000,000. BioNxt على أعتاب بدء دراسة حركية دوائية حيوانية كبيرة لمدة أسبوعين لتحديد الجرعة لدراسة حركية دوائية بشرية قادمة، وتُتابع توطين براءة الاختراع في الاتحاد الأوروبي، الولايات المتحدة (Track One)، كندا، أستراليا، نيوزيلندا، واليابان.

Positive
  • Readiness to Grant issued by EAPO for core patent family
  • Patent coverage spans 8 Eurasian states (>200,000,000 population)
  • Two-week large-mass animal bioequivalence study starting in days
  • Favorable communications from EPO and EAPO on novelty and inventive step
Negative
  • Formal Eurasian patent remains pending until publication fee is paid
  • Patent nationalization in EU, US, Canada, Australia, NZ, Japan is ongoing, not granted

VANCOUVER, BC / ACCESS Newswire / October 30, 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 issued a "Readiness to Grant" notification for the Company's comprehensive patent application for sublingual delivery of anticancer drugs for the treatment of autoimmune neurodegenerative diseases. This patent family provides numerous proprietary product development and commercialization opportunities, including BioNxt's lead product, BNT23001, a sublingual thin-film formulation of Cladribine for the treatment of multiple sclerosis (MS).

The EAPO is expected to grant the formal patent to BioNxt upon payment of a publication fee which the Company will provide to the EAPO this week. The EAPO covers Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, and Turkmenistan. These countries are the members of the Eurasian Patent Convention (EAPC), which provides a single, harmonized patent application process and regulator for the region. The EAPO grants Eurasian patents that are valid in all eight member states with a combined population of over 200,000,000.

"Solidifying patent protection is a critical part of our commercialization strategy," said Hugh Rogers, CEO of BioNxt. "The timing is excellent as the Company is days away from commencing a two-week-long large-mass animal bioequivalence study to determine dosing parameters for our upcoming human bioequivalence study. The coming months are expected to be very exciting for BioNxt as multiple clinical programs advance and our intellectual property portfolio gains international recognition and protection."

The patent nationalization process is underway in key global markets, including the European Union, Canada, Australia, Eurasia, New Zealand, and Japan, as well as a Track One priority filing in the United States. Both the European Patent Office and the Eurasian Patent Office have issued favorable communications including the formal acceptance of novelty, inventive step, and industrial applicability.

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

What does the EAPO "Readiness to Grant" mean for BioNxt (BNXTF) on October 30, 2025?

It means the EAPO has approved the application and BioNxt must pay a publication fee this week to receive the formal Eurasian patent covering 8 member states.

Which countries will the Eurasian patent cover for BioNxt (BNXTF)?

The Eurasian patent would be valid in Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, and Turkmenistan.

How does the EAPO action affect BioNxt's lead product BNT23001 (BNXTF)?

The patent family includes protection for sublingual delivery relevant to BNT23001, potentially supporting future product development and commercialization.

When will BioNxt (BNXTF) begin its large-mass animal bioequivalence study and how long will it run?

BioNxt said the study will begin in days and run for two weeks to determine dosing for a planned human bioequivalence study.

Has BioNxt (BNXTF) received similar patent feedback elsewhere besides EAPO?

Yes; BioNxt reported favorable communications from the European Patent Office and EAPO, and is pursuing nationalization in the EU, US (Track One), Canada, Australia, New Zealand, and Japan.
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