BioNxt Reports Expanded Research, Development and Commercialization Capability with Centralized Munich Laboratory
BioNxt Solutions (BNXTF) has announced the consolidation of its research, development, and commercialization activities at the Gen-Plus CRDO facility in Munich, Germany. The integration provides access to a 1,000-square-meter state-of-the-art laboratory space equipped for high-potency pharmaceutical development and GMP-compliant processes.
The company will leverage Gen-Plus's advanced infrastructure to enhance its drug delivery systems, focusing on their lead product BNT23001, a sublingual thin-film formulation of Cladribine for multiple sclerosis treatment. Immediate plans include preparation for human bioequivalence studies, including placebo trials, product transfer, manufacturing upscaling, and analytical validation.
BioNxt Solutions (BNXTF) ha annunciato la concentrazione delle sue attività di ricerca, sviluppo e commercializzazione presso la struttura Gen-Plus CRDO a Monaco di Baviera, Germania. Questa integrazione offre accesso a un laboratorio all'avanguardia di 1.000 metri quadrati, attrezzato per lo sviluppo di farmaci ad alta potenza e processi conformi alle norme GMP.
L'azienda sfrutterà l'infrastruttura avanzata di Gen-Plus per migliorare i suoi sistemi di somministrazione dei farmaci, concentrandosi sul prodotto di punta BNT23001, una formulazione sublinguale a film sottile di Cladribina per il trattamento della sclerosi multipla. I piani immediati includono la preparazione per studi di bioequivalenza umana, compresi trial con placebo, trasferimento del prodotto, aumento della produzione e validazione analitica.
BioNxt Solutions (BNXTF) ha anunciado la consolidación de sus actividades de investigación, desarrollo y comercialización en la instalación Gen-Plus CRDO en Múnich, Alemania. Esta integración brinda acceso a un laboratorio de última generación de 1.000 metros cuadrados, equipado para el desarrollo de fármacos de alta potencia y procesos conformes a GMP.
La empresa aprovechará la infraestructura avanzada de Gen-Plus para mejorar sus sistemas de administración de medicamentos, enfocándose en su producto principal BNT23001, una formulación de película delgada sublingual de Cladribina para el tratamiento de la esclerosis múltiple. Los planes inmediatos incluyen la preparación para estudios de bioequivalencia humana, incluyendo ensayos con placebo, transferencia del producto, escalado de fabricación y validación analítica.
BioNxt Solutions (BNXTF)는 독일 뮌헨에 위치한 Gen-Plus CRDO 시설에서 연구, 개발 및 상업화 활동을 통합했다고 발표했습니다. 이 통합을 통해 고효능 의약품 개발과 GMP 준수 공정을 위한 1,000평방미터 규모의 최첨단 실험실 공간을 이용할 수 있게 되었습니다.
회사는 Gen-Plus의 첨단 인프라를 활용하여 주력 제품인 BNT23001에 집중할 예정이며, 이는 다발성 경화증 치료용 클라드리빈의 설하 박막 제형입니다. 즉각적인 계획으로는 위약 시험을 포함한 인간 생물학적 동등성 연구 준비, 제품 이전, 제조 규모 확대, 분석 검증이 포함됩니다.
BioNxt Solutions (BNXTF) a annoncé la consolidation de ses activités de recherche, développement et commercialisation au sein de l'installation Gen-Plus CRDO à Munich, Allemagne. Cette intégration offre un accès à un laboratoire ultramoderne de 1 000 mètres carrés, équipé pour le développement de produits pharmaceutiques à haute puissance et les processus conformes aux normes GMP.
L'entreprise tirera parti de l'infrastructure avancée de Gen-Plus pour améliorer ses systèmes d'administration de médicaments, en se concentrant sur son produit phare BNT23001, une formulation en film mince sublingual de Cladribine pour le traitement de la sclérose en plaques. Les plans immédiats incluent la préparation des études de bioéquivalence humaine, y compris les essais avec placebo, le transfert de produit, l'augmentation de la production et la validation analytique.
BioNxt Solutions (BNXTF) hat die Zusammenführung seiner Forschungs-, Entwicklungs- und Vermarktungsaktivitäten in der Gen-Plus CRDO-Anlage in München, Deutschland bekannt gegeben. Die Integration ermöglicht den Zugang zu einem hochmodernen Labor mit 1.000 Quadratmetern, das für die Entwicklung hochwirksamer Arzneimittel und GMP-konforme Prozesse ausgestattet ist.
Das Unternehmen wird die fortschrittliche Infrastruktur von Gen-Plus nutzen, um seine Arzneimittelabgabesysteme zu verbessern, mit Fokus auf das führende Produkt BNT23001, eine sublinguale Dünnfilmformulierung von Cladribin zur Behandlung von Multipler Sklerose. Die unmittelbaren Pläne umfassen die Vorbereitung von Bioäquivalenzstudien am Menschen, einschließlich Placebo-Studien, Produkttransfer, Produktionshochskalierung und analytische Validierung.
- Access to 1,000 square meters of state-of-the-art laboratory space in a major European biotech hub
- Enhanced R&D capabilities through advanced technologies for solid and semi-solid dosage forms
- Progress towards commercialization of lead MS treatment product BNT23001
- None.
VANCOUVER, BC / ACCESS Newswire / May 13, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT), a bioscience company specializing in advanced drug delivery systems, is pleased to announce the integration of its research, development and commercialization activities to the Gen-Plus GmbH & Co. KG (Gen-Plus) Contract Research and Development Organization (CRDO) in Munich, Germany. The move provides BioNxt with enhanced R&D capabilities, collaboration opportunities, and accelerated innovation potential within a major European biotech hub.
The Company seeks to leverage the advanced and innovative infrastructure of the Gen-Plus Laboratory and harness the facility's 1,000 square meters of state-of-the-art space designed for high-potency active pharmaceutical ingredients and GMP-compliant processes. The lab's specialized equipment, including advanced technologies for solid and semi-solid dosage forms and capabilities in drug printing, will empower BioNxt to maximize the potential of its proprietary drug delivery systems, neurodegenerative disease therapeutics, and next-generation biomedical technologies.
In the coming weeks, BioNxt and Gen-Plus will be working together closely and focused on the development and commercialization of the Company's lead product, BNT23001, a sublingual thin-film formulation of Cladribine for the treatment of multiple sclerosis (MS). Preparation activities for the planned human bioequivalence study include placebo trials, product and technology transfer, upscaling of manufacturing, and analytical validation of the active pharmaceutical ingredient.
About Gen-Plus GmbH & Co. KG
Gen-Plus, headquartered in Munich, Germany, is a premier Contract Research and Development Organization (CRDO) with over 25 years of experience in pharmaceutical formulation and development. The company operates a 1,000-square-meter state-of-the-art laboratory equipped for handling high-potency active pharmaceutical ingredients and licensed for GMP-compliant production, including narcotics.
Gen-Plus specializes in developing solid and semi-solid dosage forms, transdermal patches, and oral thin films, offering end-to-end services from feasibility studies to clinical trial supply production. The company leverages advanced technologies such as hot-melt extrusion, drug printing, and amorphization of APIs to deliver comprehensive pharmaceutical solutions.
Committed to innovation, Gen-Plus collaborates with leading European research institutions and biotech companies to drive advancements in pharmaceutical solutions. The company's expertise and cutting-edge infrastructure make it a trusted partner in accelerating drug development and commercialization.
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
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Cautionary Statement Regarding "Forward-Looking" Information
This press release contains "forward-looking information" within the meaning of applicable securities laws. Forward-looking information is based on management's expectations, estimates, projections, and assumptions as of the date of this press release. It is subject to significant risks, uncertainties, and other factors that could cause actual results or events to differ materially from those expressed or implied. These risks and uncertainties include, but are not limited to, general economic conditions, market conditions, regulatory risks, technological advancements, and other factors described in the Company's public disclosure filings.
Readers are cautioned not to place undue reliance on forward-looking information, as actual outcomes may differ significantly from those expressed or implied, due to various factors beyond the Company's control. The Company undertakes no obligation to update or revise any forward-looking information, except as required by law.
SOURCE: BioNxt Solutions Inc.
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