BioNxt Solutions Unveils Accelerated 90-Day Plan: Global Patent Advancements, MS Clinical Trial, and Anti-Aging Expansion
BioNxt Solutions has announced a 90-day strategic plan focusing on three key initiatives. First, the company has completed national-level patent filings in major markets including the US, Canada, Australia, Europe, and Japan, following a positive examination report from the European Patent Office for its sublingual anticancer drug delivery system.
Second, BioNxt is preparing to commence a human bioequivalence study for BNT23001, its lead Multiple Sclerosis treatment utilizing a sublingual thin-film formulation of Cladribine. The study is expected to last less than 30 days and will serve as a proof-of-concept for the company's autoimmune disease product pipeline.
Third, the company plans to expand into the longevity and anti-aging market, which is projected to reach $93 billion by 2027. BioNxt is developing proprietary sublingual and oral drug products targeting benefits such as slowing ovarian aging, extending fertility, and promoting healthy aging.
BioNxt Solutions ha annunciato un piano strategico di 90 giorni incentrato su tre iniziative chiave. In primo luogo, l'azienda ha completato le domande di brevetto a livello nazionale nei principali mercati, tra cui Stati Uniti, Canada, Australia, Europa e Giappone, dopo un rapporto di esame positivo da parte dell'Ufficio Brevetti Europeo per il suo sistema di somministrazione di farmaci antitumorali sublinguali.
In secondo luogo, BioNxt si sta preparando a iniziare uno studio di bioequivalenza umana per BNT23001, il suo principale trattamento per la Sclerosi Multipla che utilizza una formulazione sublinguale in film sottile di Cladribina. Si prevede che lo studio duri meno di 30 giorni e servirà come prova di concetto per il pipeline di prodotti dell'azienda per le malattie autoimmuni.
Infine, l'azienda prevede di espandersi nel mercato della longevità e dell'anti-invecchiamento, che si prevede raggiunga i 93 miliardi di dollari entro il 2027. BioNxt sta sviluppando prodotti farmaceutici sublinguali e orali proprietari mirati a benefici come il rallentamento dell'invecchiamento ovarico, l'estensione della fertilità e la promozione di un invecchiamento sano.
BioNxt Solutions ha anunciado un plan estratégico de 90 días centrado en tres iniciativas clave. Primero, la empresa ha completado las solicitudes de patentes a nivel nacional en los principales mercados, incluidos EE. UU., Canadá, Australia, Europa y Japón, tras un informe de examen positivo de la Oficina Europea de Patentes para su sistema de entrega de medicamentos anticancerígenos sublinguales.
En segundo lugar, BioNxt se está preparando para comenzar un estudio de bioequivalencia humana para BNT23001, su tratamiento principal para la Esclerosis Múltiple que utiliza una formulación sublingual de película delgada de Cladribina. Se espera que el estudio dure menos de 30 días y servirá como prueba de concepto para la cartera de productos de enfermedades autoinmunes de la empresa.
Por último, la empresa planea expandirse al mercado de longevidad y anti-envejecimiento, que se proyecta alcanzará los 93 mil millones de dólares para 2027. BioNxt está desarrollando productos farmacéuticos sublinguales y orales propios dirigidos a beneficios como ralentizar el envejecimiento ovárico, extender la fertilidad y promover un envejecimiento saludable.
BioNxt Solutions는 90일 전략 계획을 발표하며 세 가지 주요 이니셔티브에 집중하고 있습니다. 첫째, 이 회사는 유럽 특허청의 긍정적인 심사 보고서를 받은 후 미국, 캐나다, 호주, 유럽 및 일본을 포함한 주요 시장에서 국가 수준의 특허 출원을 완료했습니다. 이는 항암제 전달 시스템의 경구용 약물입니다.
둘째, BioNxt는 BNT23001에 대한 인간 생물동등성 연구를 시작할 준비를 하고 있습니다. 이는 클라드리빈의 얇은 필름 제형을 이용한 다발성 경화증 치료제입니다. 연구는 30일 미만으로 진행될 예정이며, 자가면역 질환 제품 파이프라인에 대한 개념 증명으로 활용될 것입니다.
셋째, 이 회사는 2027년까지 930억 달러에 이를 것으로 예상되는 장수 및 노화 방지 시장으로의 확장을 계획하고 있습니다. BioNxt는 난소 노화를 늦추고 생식력을 연장하며 건강한 노화를 촉진하는 등의 이점을 목표로 하는 독점적인 경구 및 경구용 약물을 개발하고 있습니다.
BioNxt Solutions a annoncé un plan stratégique de 90 jours axé sur trois initiatives clés. Tout d'abord, l'entreprise a finalisé des dépôts de brevets au niveau national sur les principaux marchés, y compris les États-Unis, le Canada, l'Australie, l'Europe et le Japon, suite à un rapport d'examen positif de l'Office européen des brevets pour son système d'administration de médicaments anticancéreux sublinguaux.
Deuxièmement, BioNxt se prépare à commencer une étude de bioéquivalence humaine pour BNT23001, son traitement principal de la sclérose en plaques utilisant une formulation sublinguale en film mince de Cladribine. L'étude devrait durer moins de 30 jours et servira de preuve de concept pour le pipeline de produits de l'entreprise dans le domaine des maladies auto-immunes.
Enfin, l'entreprise prévoit de se développer sur le marché de la longévité et de l'anti-âge, qui devrait atteindre 93 milliards de dollars d'ici 2027. BioNxt développe des produits pharmaceutiques sublinguaux et oraux propriétaires visant à offrir des avantages tels que ralentir le vieillissement ovarien, prolonger la fertilité et favoriser un vieillissement sain.
BioNxt Solutions hat einen strategischen Plan für 90 Tage angekündigt, der sich auf drei wichtige Initiativen konzentriert. Erstens hat das Unternehmen nationale Patentanmeldungen in wichtigen Märkten wie den USA, Kanada, Australien, Europa und Japan abgeschlossen, nachdem ein positives Prüfungsbericht vom Europäischen Patentamt für sein sublinguales Medikamentenabgabesystem für Krebsmedikamente vorlag.
Zweitens bereitet sich BioNxt darauf vor, eine Studie zur Bioäquivalenz beim Menschen für BNT23001, seine Hauptbehandlung für Multiple Sklerose mit einer sublingualen Dünnfilmformulierung von Cladribin, zu beginnen. Die Studie wird voraussichtlich weniger als 30 Tage dauern und dient als Machbarkeitsnachweis für die Produktpipeline des Unternehmens im Bereich autoimmunerkrankungen.
Drittens plant das Unternehmen, in den Markt für Langlebigkeit und Anti-Aging einzutreten, der voraussichtlich bis 2027 93 Milliarden Dollar erreichen wird. BioNxt entwickelt proprietäre sublinguale und orale Arzneimittel, die darauf abzielen, Vorteile wie das Verlangsamen der Eierstockalterung, die Verlängerung der Fruchtbarkeit und die Förderung eines gesunden Alterns zu bieten.
- Completed national-level patent filings in major pharmaceutical markets following positive EPO examination
- Upcoming 30-day human bioequivalence study for MS treatment BNT23001
- Expansion into $93 billion longevity and anti-aging market
- Early-stage evidence only for anti-aging products
- No current revenue generation from product pipeline
VANCOUVER, BC / ACCESS Newswire / February 19, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT), a bioscience innovator specializing in advanced drug delivery systems, is pleased to report on several major milestones for the next 90 days, including the registration of national-level patents, the completion of a human bioequivalence study for its lead Multiple Sclerosis (MS) treatment, and the development of its longevity and anti-aging product.
Global Patent Filings: Accelerating Commercial Pathways for BioNxt's Pipeline
BioNxt confirm that all national-level filings pursuant to the Patent Cooperation Treaty (PCT) are complete in key jurisdictions of interest, including the United States, Canada, Australia, Europe, and Japan. The Company's national-level filings are based on the positive international examination report issued by the European Patent Office (EPO) in Q3 2024 for the Company's comprehensive patent application for sublingual delivery of anticancer drugs for the treatment of autoimmune neurodegenerative diseases, such as MS. The Company is working to accelerate the processing and registration of national-level patents with updates to be provided as they develop.
Securing nation-level patents in premier pharmaceutical markets around the globe is a central milestone for BioNxt and will serve as the foundation for commercial opportunities for the Company's pipeline of sublingual products targeting autoimmune diseases such as multiple sclerosis (MS), myasthenia gravis (MG), lupus nephritis (LN) and rheumatoid arthritis (RA).
Human Bioequivalence Study for Lead Multiple Sclerosis Product
BioNxt's lead product, BNT23001, is a proprietary sublingual thin-film formulation of Cladribine for the treatment of MS. Preclinical studies, as reported in internal research data and third-party evaluations, have demonstrated high absorption rates and bioequivalence to existing oral therapies, with plans underway to commence the first clinical trial in the next 90 days. The bioequivalence study is relatively short and scheduled for less than 30 days from start to finish.
Successful completion of the Company's sublingual Cladribine bioequivalence study is a major milestone for the Company and a proof-of-concept demonstration for BioNxt's lead product and its pipeline of sublingual products targeting autoimmune diseases.
Expansion into Longevity and Anti-Aging
In the next 90 days, BioNxt plans to enter the rapidly growing longevity and anti-aging sector, projected to reach
The Company's longevity and anti-aging programs represent a strategic and diversified investment in a large and rapidly growing global market. BioNxt looks forward to providing further details in the coming weeks.
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.
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