BioNxt Solutions Expands Patent Protection for Drug Delivery Innovations Backed by Positive IPRP
BioNxt Solutions has expanded its intellectual property portfolio by filing new international patents for sublingual delivery technologies targeting autoimmune neurodegenerative diseases. Following a positive International Preliminary Report on Patentability from the European Patent Office in September 2024, the company has initiated national-level filings in the US, Canada, Europe, and Japan.
The company's lead product, BNT23001, is a sublingual thin-film formulation of Cladribine for Multiple Sclerosis treatment. Preclinical studies have shown high absorption rates and bioequivalence to existing oral therapies. Clinical trials are planned for 2025, pending regulatory approval. BioNxt is also developing Cladribine formulations for Myasthenia Gravis, targeting a market projected to reach $6.7 billion by 2032.
BioNxt Solutions ha ampliato il proprio portafoglio di proprietà intellettuale presentando nuovi brevetti internazionali per tecnologie di somministrazione sublinguale destinate a malattie neurodegenerative autoimmuni. Dopo un positivo Rapporto Preliminare Internazionale sulla Patentabilità dall'Ufficio Europeo dei Brevetti nel settembre 2024, l'azienda ha avviato registrazioni a livello nazionale negli Stati Uniti, Canada, Europa e Giappone.
Il prodotto di punta dell'azienda, BNT23001, è una formulazione sublinguale in film sottile di Cladribina per il trattamento della Sclerosi Multipla. Gli studi preclinici hanno mostrato alti tassi di assorbimento e bioequivalenza rispetto alle terapie orali esistenti. Gli studi clinici sono previsti per il 2025, soggetti ad approvazione regolatoria. BioNxt sta anche sviluppando formulazioni di Cladribina per la Miastenia Grave, mirando a un mercato che si prevede raggiungerà i 6,7 miliardi di dollari entro il 2032.
BioNxt Solutions ha ampliado su cartera de propiedad intelectual al presentar nuevas patentes internacionales para tecnologías de entrega sublingual dirigidas a enfermedades neurodegenerativas autoinmunes. Después de un informe preliminar internacional positivo sobre patentabilidad de la Oficina Europea de Patentes en septiembre de 2024, la compañía ha iniciado solicitudes a nivel nacional en EE. UU., Canadá, Europa y Japón.
El producto principal de la empresa, BNT23001, es una formulación sublingual en película delgada de Cladribina para el tratamiento de la Esclerosis Múltiple. Los estudios preclínicos han mostrado altas tasas de absorción y bioequivalencia con las terapias orales existentes. Se planean ensayos clínicos para 2025, pendientes de aprobación regulatoria. BioNxt también está desarrollando formulaciones de Cladribina para la Miastenia Gravis, apuntando a un mercado proyectado alcanzará los 6.7 mil millones de dólares para 2032.
BioNxt Solutions는 자가면역 신경퇴행성 질환을 겨냥한 설하 투여 기술에 대한 새로운 국제 특허를 제출하여 지적 재산권 포트폴리오를 확장했습니다. 2024년 9월 유럽특허청으로부터 받은 긍정적인 국제 예비 특허 가능성 보고서를 바탕으로, 해당 회사는 미국, 캐나다, 유럽 및 일본에서 국가 수준의 출원을 시작했습니다.
회사의 주요 제품인 BNT23001은 다발성 경화증 치료를 위한 클라드리빈의 설하 얇은 필름 제형입니다. 전임상 연구에서는 높은 흡수율과 기존 경구 치료제와의 생물 동등성이 입증되었습니다. 임상 시험은 2025년으로 계획되어 있으며, 규제 승인을 기다리고 있습니다. BioNxt는 또한 중증근무력증 치료를 위한 클라드리빈 제형을 개발 중이며, 2032년까지 67억 달러에 이를 것으로 예상되는 시장을 겨냥하고 있습니다.
BioNxt Solutions a élargi son portefeuille de propriété intellectuelle en déposant de nouveaux brevets internationaux pour des technologies d'administration sublinguale ciblant les maladies neurodégénératives auto-immunes. Suite à un rapport préliminaire international positif sur la brevetabilité de l'Office européen des brevets en septembre 2024, l'entreprise a lancé des dépôts au niveau national aux États-Unis, au Canada, en Europe et au Japon.
Le produit phare de l'entreprise, BNT23001, est une formulation sublinguale en film mince de Cladribine pour le traitement de la sclérose en plaques. Des études précliniques ont montré de hautes taux d'absorption et une bioéquivalence par rapport aux thérapies orales existantes. Des essais cliniques sont prévus pour 2025, sous réserve de l'approbation réglementaire. BioNxt développe également des formulations de Cladribine pour la myasthénie, ciblant un marché dont l'on prévoit qu'il atteindra 6,7 milliards de dollars d'ici 2032.
BioNxt Solutions hat sein Portfolio an geistigem Eigentum erweitert, indem es neue internationale Patente für sublinguale Abgabe-Technologien eingereicht hat, die auf autoimmune neurodegenerative Krankheiten abzielen. Nach einem positiven internationalen vorläufigen Bericht zur Patentierbarkeit des Europäischen Patentamtes im September 2024 hat das Unternehmen nationale Anmeldungen in den USA, Kanada, Europa und Japan eingeleitet.
Das Hauptprodukt des Unternehmens, BNT23001, ist eine sublinguale dünne Film-Formulierung von Cladribin zur Behandlung von Multipler Sklerose. Präklinische Studien haben hohe Absorptionsraten und Bioäquivalenz zu bestehenden oralen Therapien gezeigt. Klinische Trials sind für 2025 geplant, vorbehaltlich der regulatorischen Genehmigung. BioNxt entwickelt auch Cladribin-Formulierungen für Myasthenia Gravis, mit dem Ziel eines Marktes, der bis 2032 voraussichtlich 6,7 Milliarden Dollar erreichen wird.
- Received positive International Preliminary Report on Patentability (IPRP) from European Patent Office
- Expanded patent protection in major markets (US, Canada, Europe, Japan)
- Preclinical studies showed high absorption rates and bioequivalence to existing therapies
- Targeting Myasthenia Gravis market with $6.7 billion potential by 2032
- Clinical trials yet to commence, pending regulatory approval
- Revenue generation dependent on future clinical trial success and commercialization
VANCOUVER, BC / ACCESSWIRE / December 19, 2024 / 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 announce the expansion of its intellectual property portfolio with the filing of new international patents for sublingual delivery technologies targeting autoimmune neurodegenerative diseases.
Building upon the positive International Preliminary Report on Patentability (IPRP) issued by the European Patent Office (EPO) in September 2024, BioNxt has initiated national-level filings in key jurisdictions, including the United States, Canada, Europe, and Japan. These patents are designed to protect the Company's proprietary sublingual formulations of anticancer drugs repurposed for the treatment of conditions such as Multiple Sclerosis (MS).
"Securing robust intellectual property rights across major markets is a critical component of our strategy to bring innovative, patient-friendly therapies to individuals affected by autoimmune neurodegenerative diseases," stated Hugh Rogers, CEO of BioNxt Solutions. "Our sublingual delivery platform offers significant advantages in terms of rapid absorption and ease of administration, particularly for patients experiencing difficulty swallowing."
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 clinical trials in 2025, subject to regulatory approval.
In addition to MS, the Company is advancing sublingual Cladribine formulations for Myasthenia Gravis (MG), addressing a significant unmet need in this patient population. The global MG market is projected to reach USD 6.7 billion by 2032 (Clinical Trials Arena), highlighting the substantial opportunity for innovative treatments.
Strategic Vision for 2025 and Key Milestones
As BioNxt enters 2025, the Company has set a series of critical milestones to advance its sublingual drug delivery platform and bring its innovative therapies closer to commercialization. Key objectives for 2025 include:
Initiation of Clinical Trials: Launching comparative bioequivalence trials for BNT23001, BioNxt's proprietary sublingual Cladribine formulation for Multiple Sclerosis (MS).
Regulatory Submissions: Preparing and submitting clinical trial applications (CTAs) in key jurisdictions to support clinical trial activities.
Partnership Development: Pursuing strategic partnerships with pharmaceutical and biotech companies to accelerate development and commercialization pathways.
Pipeline Expansion: Advancing the development of sublingual therapies and exploring additional applications for its sublingual delivery technology.
Investor and Industry Engagement: BioNxt's management will actively participate in key industry conferences throughout 2025, to meet with industry leaders, engage with investors, and explore potential strategic partnerships.
Industry Collaboration and Strategic Alliances
To foster industry collaboration and partnership development, BioNxt's management team, including CEO, Hugh Rogers, and Director of Business Development, Dr. Oleksandr Zabutkin, will attend key global conferences in 2025, to meet with industry leaders, potential partners, and investors. These engagements aim to strengthen the Company's strategic alliances, identify co-development and licensing opportunities, and highlight BioNxt's role in advancing sublingual drug delivery technologies.
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 accesswire.com
FAQ
What is the status of BioNxt's (BNXTF) patent protection for its drug delivery innovations?
When will BioNxt (BNXTF) begin clinical trials for its MS treatment BNT23001?
What is the market potential for BioNxt's (BNXTF) Myasthenia Gravis treatment?
What are the key development milestones for BioNxt (BNXTF) in 2025?
