Semaglutide API Delivery Enables Start of Lab-Scale ODF Development at BioNxt
BioNxt Solutions (OTC:BNXTF) has announced the receipt of Semaglutide API, enabling the start of laboratory-scale development for their oral dissolvable film (ODF) delivery system. The company will conduct development activities at their German partner Gen-Plus GmbH in Munich, focusing on optimizing drug incorporation, testing peptide stability, and developing analytical methods.
The development program aims to create an alternative delivery method for Semaglutide, a GLP-1 receptor agonist currently marketed as Ozempic® and Rybelsus®, which generated over $29.3 billion in sales in 2024. BioNxt plans to file a provisional patent in Q3 2025 and is positioning this as the first in a series of GLP-1-based therapies using their ODF platform.
BioNxt Solutions (OTC:BNXTF) ha annunciato di aver ricevuto l'API del Semaglutide, permettendo l'avvio dello sviluppo su scala di laboratorio del loro sistema di somministrazione a film orodissolubile (ODF). Le attività di sviluppo saranno svolte presso il partner tedesco Gen-Plus GmbH a Monaco e si concentreranno sull'ottimizzazione dell'incorporazione del principio attivo, sulla verifica della stabilità del peptide e sull'elaborazione di metodi analitici.
Il programma di sviluppo punta a creare un metodo alternativo di somministrazione per il Semaglutide, un agonista del recettore GLP-1 attualmente commercializzato come Ozempic® e Rybelsus®, che ha generato oltre 29,3 miliardi di dollari di ricavi nel 2024. BioNxt prevede di depositare un brevetto provvisorio nel terzo trimestre 2025 e lo presenta come il primo di una serie di terapie basate su GLP-1 sviluppate con la sua piattaforma ODF.
BioNxt Solutions (OTC:BNXTF) ha anunciado la recepción del API de Semaglutida, lo que permite iniciar el desarrollo a escala de laboratorio de su sistema de administración en film orodispersable (ODF). La compañía llevará a cabo las actividades de desarrollo en su socio alemán Gen-Plus GmbH en Múnich, centrándose en optimizar la incorporación del fármaco, evaluar la estabilidad del péptido y desarrollar métodos analíticos.
El programa de desarrollo tiene como objetivo crear un método alternativo de administración para la Semaglutida, un agonista del receptor GLP-1 comercializado como Ozempic® y Rybelsus®, que generó más de 29.300 millones de dólares en ventas en 2024. BioNxt planea presentar una solicitud de patente provisional en el tercer trimestre de 2025 y lo posiciona como el primero de una serie de terapias basadas en GLP-1 utilizando su plataforma ODF.
BioNxt Solutions (OTC:BNXTF)가 세마글루타이드 원료의약품(API)을 수령했다고 발표했으며, 이를 통해 경구용 용해 필름(ODF) 전달 시스템의 실험실 규모 개발을 시작할 수 있게 되었습니다. 회사는 독일 파트너인 Gen-Plus GmbH(뮌헨)에서 약물 혼입 최적화, 펩타이드 안정성 평가 및 분석 방법 개발에 중점을 두고 개발 활동을 진행할 예정입니다.
개발 프로그램은 Ozempic® 및 Rybelsus®로 시판 중인 GLP-1 수용체 작용제인 세마글루타이드의 대체 전달 방식을 만드는 것을 목표로 하며, 해당 제품은 2024년 매출 293억 달러 이상을 기록했습니다. BioNxt는 2025년 3분기에 예비 특허를 출원할 계획이며, 이를 자사의 ODF 플랫폼을 활용한 GLP-1 기반 치료제 시리즈의 첫 번째로 자리매김시키고자 합니다.
BioNxt Solutions (OTC:BNXTF) a annoncé la réception de l'API de sémaglutide, permettant le démarrage du développement à l'échelle laboratoire de son système d'administration par film orodispersible (ODF). La société réalisera les activités de développement chez son partenaire allemand Gen-Plus GmbH à Munich, en se concentrant sur l'optimisation de l'incorporation du principe actif, le test de la stabilité du peptide et le développement de méthodes analytiques.
Le programme de développement vise à créer une voie d'administration alternative pour le sémaglutide, un agoniste du récepteur GLP-1 commercialisé sous les noms Ozempic® et Rybelsus®, qui a généré plus de 29,3 milliards de dollars de ventes en 2024. BioNxt prévoit de déposer une demande de brevet provisoire au troisième trimestre 2025 et positionne ce projet comme le premier d'une série de thérapies à base de GLP-1 utilisant sa plateforme ODF.
BioNxt Solutions (OTC:BNXTF) hat den Erhalt des Semaglutid-API bekanntgegeben, was den Start der laborbasierten Entwicklung ihres oral auflösbaren Film(ODF)-Verabreichungssystems ermöglicht. Die Entwicklungsarbeiten werden beim deutschen Partner Gen-Plus GmbH in München durchgeführt und konzentrieren sich auf die Optimierung der Wirkstoffeinbindung, die Prüfung der Peptidstabilität und die Entwicklung analytischer Methoden.
Das Entwicklungsprogramm zielt darauf ab, eine alternative Verabreichungsform für Semaglutid zu schaffen, einen GLP-1-Rezeptoragonisten, der derzeit als Ozempic® und Rybelsus® vermarktet wird und im Jahr 2024 über 29,3 Milliarden US-Dollar Umsatz erzielte. BioNxt plant, im dritten Quartal 2025 eine vorläufige Patentanmeldung einzureichen und positioniert dies als das erste einer Reihe von GLP-1-basierten Therapien auf Basis ihrer ODF-Plattform.
- Development of potential non-invasive delivery format for high-demand GLP-1 drug Semaglutide
- Access to GMP-aligned laboratory infrastructure through Gen-Plus partnership
- Targeting large market opportunity with Semaglutide sales exceeding $29.3B in 2024
- Strategic positioning as first in planned series of GLP-1-based therapies
- Early-stage development with no guaranteed success
- Patent protection not yet secured
- Faces competition from established delivery methods and brands
VANCOUVER, BC / ACCESS Newswire / September 2, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC PINK:XPHYF)(FSE:4XT) is pleased to announce the receipt of the Semaglutide active pharmaceutical ingredient (API), enabling the initiation of laboratory-scale formulation and testing of the Company's oral dissolvable film (ODF) delivery system.
In collaboration with its qualified supply partners, BioNxt has secured high-purity Semaglutide as the central compound for its proprietary ODF formulation program. The API's fundamental physical and chemical properties - such as solubility, molecular stability, and loading capacity - are foundational to formulation design and product performance. With the API now in hand, BioNxt's formulation team is executing pre-formulation and lab-scale trials to optimize delivery parameters.
Initial research and development efforts will focus on optimizing drug incorporation within the sublingual thin film matrix, characterizing disintegration time, testing peptide stability under formulation conditions, and developing analytical methods to ensure uniformity, controlled release, and shelf-life performance.
"Having the API in-house allows us to translate theory into practice," said Hugh Rogers, CEO at BioNxt Solutions. "We're focused on generating reliable data to inform formulation refinement and position the project for patent protection in the coming quarter."
Gen Plus: BioNxt's European Drug Development Hub
All laboratory development activities for the Semaglutide oral film are being conducted at Gen-Plus GmbH, BioNxt's German drug development partner, located in Munich, Germany. Gen-Plus is a licensed drug developer and manufacturer specializing in pharmaceutical thin film formulations and novel dosage forms.
Gen-Plus provides GMP-aligned laboratory infrastructure, in-house expertise in polymer science and peptide formulation, and regulatory readiness for clinical development in the European Union. The Munich facility serves as BioNxt's core technical center for thin film research, formulation prototyping, and early-stage product development. The Semaglutide program builds on Gen-Plus's proven experience in oral and transdermal delivery technologies for both small molecules and complex biologics.
Advancing Toward Prototype and Patent
With laboratory work now underway, the next milestones in the development timeline include completion of formulation trials, characterization of peptide stability, and production of first-generation film prototypes. These efforts will generate the technical foundation required to support a provisional patent filing planned for the third quarter of 2025.
Semaglutide, currently marketed under the brand names Ozempic® and Rybelsus®, is a leading GLP-1 receptor agonist approved for the treatment of type 2 diabetes and obesity. Global demand for GLP-1 therapies is growing rapidly, with Semaglutide accounting for more than USD 29.3 billion in sales in 2024. BioNxt's oral thin film version is intended to improve accessibility and patient compliance through a non-invasive delivery format. Semaglutide is the first in a planned series of GLP-1-based therapies being developed using BioNxt's proprietary ODF platform.
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: +1 780-818-6422
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 related to the Company's oral thin film (ODF) development program for Semaglutide; the anticipated timing and outcomes of formulation studies; the potential for future patent filings; market growth projections; and the broader applicability of the Company's drug delivery technologies.
Forward-looking information is based on management's reasonable assumptions, expectations, estimates, and projections as of the date of this press release. Such statements are subject to various 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: scientific and technical development risks; manufacturing and scalability risks; intellectual property protection; regulatory approval processes; competition in the GLP-1 drug market; and general economic, financial, and market conditions.
Readers are cautioned not to place undue reliance on forward-looking information. Although the Company believes 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, the Company undertakes no obligation to update or revise any forward-looking information, whether as a result of new information, future events, or otherwise.
Ozempic® and Rybelsus® are registered trademarks of Novo Nordisk A/S and are not affiliated with or developed by BioNxt Solutions Inc.
SOURCE: BioNxt Solutions Inc.
View the original press release on ACCESS Newswire
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