BioNxt Fast-Tracks U.S. Patent for MS Drug and Secures Broad Platform IP Covering Autoimmune Neurology Pipeline
BioNxt Solutions (OTC:BNXTF) has achieved two significant intellectual property milestones for its neurological autoimmune drug delivery platform. The company has initiated fast-track patent examination for BNT23001, its novel sublingual thin-film cladribine formulation for multiple sclerosis, through the USPTO's Track One Program, potentially securing patent protection within 12 months.
Additionally, BioNxt received acceptance of core claims for a broad international patent extending into the 2040s, protecting its sublingual thin-film delivery technology across multiple diseases and applications. The company's lead product targets a combined addressable market of $42-46 billion by 2032 for MS and generalized myasthenia gravis (GMG). BioNxt aims to demonstrate superior bioavailability compared to Merck's MAVENCLAD®, which generated over $1 billion in sales in 2023.
BioNxt Solutions (OTC:BNXTF) ha raggiunto due importanti traguardi in ambito proprietà intellettuale per la sua piattaforma di somministrazione di farmaci per malattie neurologiche autoimmuni. L'azienda ha avviato l'esame accelerato del brevetto per BNT23001, la sua innovativa formulazione sublinguale in film sottili di cladribina per la sclerosi multipla, tramite il programma Track One dell'USPTO, con la possibilità di ottenere la protezione brevettuale entro 12 mesi.
Inoltre, BioNxt ha ottenuto l'accettazione delle rivendicazioni principali di un ampio brevetto internazionale valido fino agli anni 2040, che tutela la sua tecnologia di somministrazione sublinguale in film sottili per più malattie e applicazioni. Il prodotto di punta dell'azienda mira a un mercato indirizzabile combinato di $42-46 miliardi entro il 2032 per SM e miastenia gravis generalizzata (GMG). BioNxt intende dimostrare una biodisponibilità superiore rispetto a MAVENCLAD® di Merck, che ha generato oltre $1 miliardo di vendite nel 2023.
BioNxt Solutions (OTC:BNXTF) ha alcanzado dos hitos importantes en propiedad intelectual para su plataforma de administración de fármacos en enfermedades neurológicas autoinmunes. La compañía ha solicitado el examen acelerado de la patente para BNT23001, su nueva formulación sublingual en película delgada de cladribina para esclerosis múltiple, a través del programa Track One de la USPTO, con posibilidad de asegurar protección patentaria en 12 meses.
Además, BioNxt recibió la aceptación de las reivindicaciones centrales de una amplia patente internacional con vigencia hasta los años 2040, que protege su tecnología de administración sublingual en película delgada para diversas enfermedades y usos. El producto principal de la compañía se dirige a un mercado combinable de $42-46 mil millones para 2032 en EM y miastenia gravis generalizada (GMG). BioNxt pretende demostrar una biodisponibilidad superior a la de MAVENCLAD® de Merck, que generó más de $1 mil millones en ventas en 2023.
BioNxt Solutions (OTC:BNXTF)는 신경계 자가면역 질환 약물 전달 플랫폼과 관련해 두 가지 주요 지적재산권 성과를 달성했습니다. 회사는 다발성경화증용 설하 박막 클라드리빈 제형인 BNT23001에 대해 USPTO의 Track One 프로그램을 통해 신속 심사 절차를 개시했으며, 이를 통해 12개월 이내에 특허 보호를 확보할 가능성이 있습니다.
또한 BioNxt는 2040년대까지 확장되는 광범위한 국제 특허의 핵심 청구항 승인을 받았으며, 이는 다양한 질환과 용도에 걸쳐 자사의 설하 박막 전달 기술을 보호합니다. 회사의 주력 제품은 2032년까지 MS 및 전신성 중증근무력증(GMG)을 합한 $420–460억 규모의 주소 지정 가능한 시장을 목표로 합니다. BioNxt는 2023년에 $10억 이상의 매출을 올린 Merck의 MAVENCLAD®보다 우수한 생체이용률을 입증하는 것을 목표로 합니다.
BioNxt Solutions (OTC:BNXTF) a franchi deux étapes importantes en matière de propriété intellectuelle pour sa plateforme d'administration de médicaments contre les maladies neurologiques auto-immunes. La société a demandé l'examen accéléré du brevet pour BNT23001, sa nouvelle formulation sublinguale en film mince de cladribine pour la sclérose en plaques, via le programme Track One de l'USPTO, pouvant obtenir une protection brevêtaire sous 12 mois.
De plus, BioNxt a obtenu l'acceptation des revendications principales d'un large brevet international s'étendant jusqu'aux années 2040, protégeant sa technologie d'administration sublinguale en film mince pour plusieurs maladies et usages. Le produit phare vise un marché adressable combiné de 42–46 milliards de dollars d'ici 2032 pour la SEP et la myasthénie généralisée (GMG). BioNxt entend démontrer une biodisponibilité supérieure à celle de MAVENCLAD® de Merck, qui a généré plus de 1 milliard de dollars de ventes en 2023.
BioNxt Solutions (OTC:BNXTF) hat zwei bedeutende Meilensteine im Bereich geistiges Eigentum für seine Wirkstoffabgabeplattform bei neurologischen Autoimmunerkrankungen erreicht. Das Unternehmen hat die beschleunigte Prüfung des Patents für BNT23001, seine neuartige sublinguale Dünnschicht-Formulierung von Cladribin für Multiple Sklerose, über das Track One-Programm des USPTO eingeleitet und könnte damit innerhalb von 12 Monaten Patentschutz erhalten.
Zusätzlich erhielt BioNxt die Annahme der Kernansprüche für ein umfangreiches internationales Patent, das bis in die 2040er Jahre reicht und seine sublinguale Dünnschicht-Deliver-Technologie für mehrere Krankheiten und Anwendungen schützt. Das Leitprodukt des Unternehmens adressiert einen kombinierten Zielmarkt von $42–46 Milliarden bis 2032 für MS und generalisierte Myasthenia gravis (GMG). BioNxt will eine höhere Bioverfügbarkeit gegenüber Mercks MAVENCLAD® nachweisen, das 2023 mehr als $1 Milliarde Umsatz erzielte.
- Fast-track USPTO patent review could secure protection within 12 months
- Broad international patent protection extending into 2040s
- Platform targets $42-46 billion addressable market by 2032
- Potential accelerated regulatory pathway if superior bioavailability is demonstrated
- Technology could improve patient compliance and drug absorption
- Bioequivalence studies still pending
- Success depends on demonstrating superior bioavailability to existing treatments
- Competitive market with established players like Merck
VANCOUVER, BC / ACCESS Newswire / August 20, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT), a bioscience company specializing in innovative drug delivery technologies, is pleased to announce two key milestones in the expansion and protection of its proprietary drug delivery platform targeting neurological autoimmune disorders. The Company has formally initiated the prioritized examination process for its U.S. patent application for BNT23001, a novel sublingual thin-film cladribine formulation for multiple sclerosis (MS), under the United States Patent and Trademark Office's (USPTO) Track One Program. Simultaneously, BioNxt has received acceptance of core claims for a broad international patent designed as a platform-level umbrella protecting the Company's sublingual thin-film delivery technology across a wide range of diseases, drug compounds, and applications.
Fast-Tracked U.S. Patent Filing via Track One to Accelerate Clinical Development Milestones
BioNxt is pursuing the USPTO's Track One Prioritized Examination Program to accelerate patent review for BNT23001. Once accepted, this program enables final patent disposition within 12 months, with most applicants receiving a first Office Action in approximately two months and a final decision in under seven months. For BioNxt, this fast-track status represents a strategic opportunity to secure near-term U.S. patent protection and strengthen its IP position ahead of pivotal bioequivalence studies and commercial partnering discussions.
BNT23001 is an orally dissolvable thin-film formulation of cladribine, a well-established immunomodulatory compound. 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.
A Strategic Path Toward Superbioavailability and Rapid Approval
BioNxt is advancing BNT23001 for relapsing-remitting MS (RRMS) and primary progressive MS (PPMS), as well as generalized myasthenia gravis (GMG). Merck KGaA is currently conducting a Phase 3 clinical trial to evaluate cladribine capsules in GMG (ClinicalTrials.gov: NCT06463587), further validating the therapeutic relevance of the compound beyond MS. This clinical activity by Merck reinforces the therapeutic relevance of cladribine in GMG and underscores the opportunity for BioNxt to differentiate and potentially partner or collaborate with its own next-generation, patient-centric delivery format.
BioNxt's objective is to confirm that its sublingual thin film offers superbioavailability in comparison to Merck's MAVENCLAD® tablets, which generated more than US
BioNxt's Broad Patent: A Platform-Level Umbrella for Autoimmune Neurology
In parallel to its U.S. patent fast-tracking, BioNxt has achieved a major intellectual property milestone with the acceptance of core claims in its broad international umbrella patent protecting its thin-film delivery platform. This foundational patent is not limited to BNT23001, but instead provides platform-level protection for a wide range of drug compounds, therapeutic indications, administration methods, and manufacturing processes.
The umbrella patent provides long-term exclusivity, extending into the 2040s, not only for cladribine, but for a broad class of drug compounds delivered via BioNxt's proprietary sublingual thin-film technology. This includes protection for composition, manufacturing, administration methods, and use across multiple autoimmune and neuroinflammatory indications.
Key disease targets include relapsing-remitting and primary progressive multiple sclerosis, generalized myasthenia gravis, neuromyelitis optica spectrum disorders (NMOSD), autoimmune encephalitis, central nervous system (CNS) vasculitis, optic neuritis, Hashimoto's encephalopathy, cerebral lupus, and Sjögren's syndrome. While Sjögren's is primarily known for its effects on exocrine glands, it is also associated with neurological complications in some patients.
The patent has received core claim acceptance from both the European Patent Office (EPO) and the Eurasian Patent Organization (EAPO), and BioNxt has initiated national-phase filings in the United States, Canada, Japan, Australia, and New Zealand. This patent framework enables BioNxt to scale its platform across additional indications using the same delivery modality, reducing development timelines and leveraging shared regulatory infrastructure.
Targeting Global Markets and Significant Unmet Need
Autoimmune neurodegenerative diseases represent a significant global burden with limited therapeutic options and poor adherence to existing therapies. BioNxt's thin-film delivery technology is designed to improve tolerability and usability across these patient populations. Unlike conventional tablets or injectable formulations, BioNxt's thin-film platform bypasses the gastrointestinal tract, supports rapid absorption, and improves dosing convenience, critical in chronic autoimmune disorders where long-term adherence is essential.
More than 2.8 million people are living with multiple sclerosis (MS) globally, including nearly 1 million in the United States alone, according to the National Multiple Sclerosis Society and a 2019 study published in Neurology (Wallin et al., 2019; National MS Society). The U.S. MS drug market was valued at USD 7.81 billion in 2024 and is forecast to grow to over USD 17.15 billion by 2034, reflecting a CAGR of
Generalized myasthenia gravis affects an estimated 700,000 people globally and remains an area of unmet therapeutic need (ClinicalTrialsArena, 2023). BioNxt estimates that its initial target indications, MS and GMG, represent a combined total addressable market of USD 42-46 billion by 2032, based on internal analysis and third-party forecasting. The central nervous system therapeutics market is projected to exceed USD 239 billion by 2032, highlighting the broader opportunity for innovation in neuroimmunology (GMI Insights, 2024).
The Company expects to report results from its preclinical PK study later this year, supporting its regulatory strategy and partnership discussions.
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"). 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.
Mavenclad® is a registered trademark of Merck KGaA, Darmstadt, Germany. It is not affiliated with or endorsed by BioNxt Solutions Inc.
SOURCE: BioNxt Solutions Inc.
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FAQ
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