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BioNxt Solutions (OTCQB:BNXTF) announced that its German subsidiary received an “Intention to Grant” from the European Patent Office for European patent application no. 23 729 446.7 covering a sublingual cladribine thin-film for multiple sclerosis. Combined with an EAPO “Readiness to Grant,” filings could provide potential protection across up to 54 jurisdictions and an addressable population of nearly 1 billion people, subject to national validation and maintenance. The patents claim a cladribine-cyclodextrin complex thin film intended for rapid transmucosal absorption. BioNxt is also pursuing U.S., North America, and Japan filings, completing a large-mass animal bioequivalence study, and planning a human bioequivalence trial while seeking co-development and out-licensing partners.
BioNxt Solutions (OTCQB:BNXTF) ha annunciato che la sua controllata tedesca ha ricevuto una Intenzione di concessione dall’Ufficio Europeo dei Brevetti per la domanda di brevetto europea n. 23 729 446.7 che copre una pellicola sottile sublinguale di cladribina per la sclerosi multipla. Insieme a una Readiness to Grant dell’EAPO, le domande potrebbero offrire protezione potenziale in fino a 54 giurisdizioni e una popolazione accessibile di quasi 1 miliardo di persone, soggetta a convalida e manutenzione nazionali. I brevetti rivendicano un film sottile a base di cladribina-ciclodextrina destinato a un rapido assorbimento transmucoso. BioNxt sta inoltre perseguendo domande negli Stati Uniti, in Nord America e in Giappone, completando uno studio di bioequivalenza su animale di grande massa e pianificando una prova di bioequivalenza nell’uomo, mentre cerca partner per co-sviluppo e licensing esterno.
BioNxt Solutions (OTCQB:BNXTF) anunció que su filial alemana recibió una Intención de Concesión de la Oficina Europea de Patentes para la solicitud de patente europea n° 23 729 446.7 que cubre una película delgada sublingual de cladribina para la esclerosis múltiple. Combinada con una Readiness to Grant de la EAPO, las presentaciones podrían proporcionar protección potencial en hasta 54 jurisdicciones y una población alcanzable de casi 1.000 millones de personas, sujeta a validación y mantenimiento nacionales. Las patentes reclaman una película delgada de cladribina-Complejo con ciclodextrina destinada a una rápida absorción transmucosa. BioNxt también está persiguiendo presentaciones en Estados Unidos, Norteamérica y Japón, completando un estudio de bioequivalencia en animales de gran masa y planificando un ensayo de bioequivalencia en humanos, mientras busca socios para co-desarrollo y licensing externo.
BioNxt Solutions (OTCQB:BNXTF)는 독일 자회사가 유럽 특허청으로부터 Intention to Grant를 받았다고 발표했습니다. 이는 유럽 특허 출원 번호 23 729 446.7을 다루며 설하 집중형 클라드리빈 박막을 대상으로 하는 다발성 경화증용 특허입니다. EAPO의 Readiness to Grant와 결합하면 최대 54개 관할권에서의 보호 가능성과 거의 10억 명에 달하는 주소 가능 인구를 제공할 수 있으며, 이는 국가별 확인 및 유지에 달려 있습니다. 특허는 빠른 점막 흡수를 목표로 한 클라드리빈-사이클로덱스트린 복합체 박막를 청구합니다. BioNxt는 또한 미국, 북미, 일본의 출원을 추구하고 있으며, 대용량 동물 생물학적 동등성 연구를 완료하고 인간 생물학적 동등성 시험을 계획하는 한편 공동 개발 및 라이선스 아웃 파트너를 모색하고 있습니다.
BioNxt Solutions (OTCQB:BNXTF) a annoncé que sa filiale allemande a reçu une Intention de Grant de l’Office européen des brevets pour la demande de brevet européen n° 23 729 446.7 couvrant un film sous-lingual à base de cladribine pour la sclérose en plaques. Associée à une Readiness to Grant de l’EAPO, les dépôts pourraient offrir une protection potentielle dans jusqu’à 54 juridictions et une population adressable de près d’un milliard de personnes, sous réserve de validation et de maintenance nationales. Les brevets revendiquent un film mince à base de cladribine-cyclodextrine destiné à une absorption transmucosa rapide. BioNxt poursuit également des dépôts aux États‑Unis, en Amérique du Nord et au Japon, en complétant une étude de biodisponibilité sur des animaux de masse et en prévoyant un essai d’équivalence biologique chez l’homme, tout en recherchant des partenaires de co-développement et de licensing.
BioNxt Solutions (OTCQB:BNXTF) gab bekannt, dass ihre deutsche Tochtergesellschaft eine Intention to Grant vom Europäischen Patentamt für die europäische Patentanmeldung Nr. 23 729 446.7 erhalten hat, die einen sublingualen Cladribin-Schmelfilm für Multiples Sklerose abdeckt. In Verbindung mit einer Readiness to Grant der EAPO könnten die Einreichungen potenziellen Schutz in bis zu 54 Jurisdiktionen und einer adressierbaren Bevölkerung von fast eineinhalb Milliarden Menschen bieten, vorbehaltlich nationaler Validierung und Wartung. Die Patente beanspruchen einen Cladribin-Cyclodextrin-Komplex-Schmelfilm, der für eine schnelle transmukosale Absorption bestimmt ist. BioNxt verfolgt zudem Anmeldungen in den USA, Nordamerika und Japan, führt eine Bioäquivalenzstudie an großen Tieren durch und plant einen menschlichen Bioäquivalenztest, während sie Partner für Co-Development und Out-Lizenzierung sucht.
BioNxt Solutions (OTCQB:BNXTF) أعلنت أن الشركة التابعة لها في ألمانيا تلقت من مكتب البراءات الأوروبي نية المنح لـ طلب البراءة الأوروبي رقم 23 729 446.7 الذي يغطي طبقة فيلمية سطحية فموية من الكلادريبين لمرض التصلب المتعدد. وبالإضافة إلى Readiness to Grant من EAPO، قد توفر الطلبات حماية محتملة في حتى 54 ولاية قضائية وسكاناً قابلاً للوصول يقارب مليار شخص، رهناً بالتصديق الوطني والصيانة. تدّعي براءات الاختراع طبقة فيلمية دقيقة من مركب الكلادريبين-سيليلوديكسترين مُعدة لامتصاص عبر الغشاء المخاطي بسرعة. تسعى BioNxt أيضاً إلى تقديم طلبات في الولايات المتحدة، أمريكا الشمالية واليابان، وتكمل دراسة التوافقة الحيوية الحيوانية كبيرة الكتلة وتخطط لتجربة توافر بيولوجي بشري، في حين تبحث عن شركاء للتطوير المشترك والتراخيص الخارجية.
Positive
- Intention to Grant received from the European Patent Office
- Potential patent protection across up to 54 jurisdictions
- Addressable population of nearly 1 billion people in covered regions
- Lead candidate BNT23001 targets patient-friendly sublingual delivery
Negative
- EPO “Intention to Grant” is not a final patent; subject to validation
- Commercialization depends on national validation and maintenance requirements
- BNT23001 remains pre‑human; only a large‑mass animal study is complete
- Regulatory and partnering outcomes required before market entry
11/04/2025 – 03:05 AM
VANCOUVER, BC – BioNxt Solutions Inc. (BNXTF) is making strides in its quest to revolutionize multiple sclerosis (MS) treatment. The company’s German subsidiary has received a significant boost with an “Intention to Grant” notification from the European Patent Office (EPO) regarding its sublingual cladribine thin-film formulation. This development, coupled with a “Readiness to Grant” from the Eurasian Patent Organization (EAPO), potentially secures patent protection across up to 54 jurisdictions, encompassing a market of nearly one billion people. The news underscores BioNxt’s commitment to innovative drug delivery platforms and its focus on patient-centric solutions.
The patent application (no. 23 729 446.7) centers on a unique cladribine-cyclodextrin complex thin film designed for rapid transmucosal absorption. This delivery method aims to improve bioavailability and patient adherence compared to traditional oral tablets or injectable therapies, key factors in managing chronic conditions like MS. While the “Intention to Grant” is a positive signal, industry analysts caution that it is not a final patent guarantee and will require national validation and maintenance to achieve full protection. Nevertheless, the breadth of potential coverage across European and Eurasian territories positions BioNxt favorably within a competitive MS treatment landscape.
BioNxt is not limiting its intellectual property efforts to Europe. The company is actively pursuing patent filings in the United States, North America, and Japan, indicating a comprehensive global strategy. This move aligns with their ongoing efforts to advance BNT23001, the company’s lead MS candidate, through various stages of development. These include completing large-mass animal bioequivalence studies, planning human bioequivalence trials, and actively seeking co-development and out-licensing partnerships.
The company is targeting a substantial and growing market. Stellar Market Research estimates the European MS treatment market at $7.95 billion in 2024, projecting a robust growth to $13.56 billion by 2032 (CAGR of ~6.9%). A key trend driving this growth is the increasing preference for oral therapies, which are projected to hold a leading share of the market. Oral treatments offer convenient administration, improved adherence, and enhanced quality of life for patients, a critical factor in long-term disease management. BioNxt’s sublingual film aims to further improve upon existing oral therapies (like MAVENCLAD®) by offering a water-free, rapidly dissolving formulation.
“Securing patent protection in both Europe and Eurasia marks a major step forward,” stated Hugh Rogers, CEO of BioNxt Solutions Inc., highlighting the strategic significance of this development. BioNxt’s near-term goals include completing bioequivalence studies and securing the necessary partnerships to advance BNT23001 through clinical trials and regulatory approval. The company’s diversified approach, encompassing innovative drug delivery and strategic market positioning, could offer a valuable new option for MS patients seeking convenient and effective treatment solutions.
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.
Disclaimer: Investment decisions should be made with consideration of risks and independent research, as forward-looking statements are estimates involving risks and uncertainties.
FAQ
What did BioNxt (BNXTF) announce on November 4, 2025 regarding patents in Europe?
BioNxt reported an EPO “Intention to Grant” for European patent application no. 23 729 446.7 covering a sublingual cladribine thin-film.
How many jurisdictions could BioNxt’s patents potentially cover for BNXTF’s cladribine film?
The filings could provide potential protection across up to 54 jurisdictions, subject to national validation and maintenance.
What is the addressable population for BioNxt’s patented cladribine thin-film (BNXTF)?
Company materials cite an addressable population of nearly 1 billion people across Europe, Eurasia, and validation states.
What development steps did BioNxt say are next for BNT23001 (BNXTF)?
BioNxt is completing a large‑mass animal bioequivalence study, planning a human bioequivalence trial, and pursuing partnerships.
Does the EPO “Intention to Grant” mean immediate market exclusivity for BNXTF?
No; the notice is preliminary and not final—national validation, maintenance, and approvals are required for enforceable rights.
How does BioNxt position BNT23001 versus existing oral cladribine therapies (BNXTF)?
BioNxt describes a swallow‑free, rapidly dissolving thin film designed to improve administration, absorption, and patient adherence versus tablets.
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