BioNxt, Solutions

BioNxt Solutions Secures Key Patent for Multiple Sclerosis Treatment

21.11.2025 - 08:11:04

Bionxt Solutions CA0909741062

BioNxt Solutions has achieved a significant strategic milestone, announcing the grant of crucial patent protection for its lead drug candidate. This development arrives after a period of notable stock price volatility and could serve as a catalyst for the company's valuation.

The Eurasian Patent Organization has officially awarded BioNxt patent number 051510. This intellectual property protects the sublingual administration of medications for autoimmune diseases, specifically covering the company's primary candidate, BNT23001, for treating Multiple Sclerosis (MS). The legal protection remains in effect until June 2043 and encompasses eight member states, including Russia.

Chief Executive Hugh Rogers described the patent grant as a "pivotal moment" for the biotechnology firm. This represents BioNxt's first nationally-granted patent and establishes the foundation for planned commercialization efforts. The announcement comes at a time when the company has been seeking positive catalysts to stabilize its share performance.

Global Expansion of Intellectual Property

Company executives indicate this Eurasian patent represents just the initial phase of a comprehensive worldwide intellectual property strategy. Earlier in November, the European Patent Office (EPO) signaled its intention to grant a corresponding patent through an "Intention to Grant" notice. Parallel patent proceedings are currently advancing in several major markets, including the United States, Canada, Australia, and Japan.

The strategic objective behind this global patent push is clear: BioNxt is systematically building competitive barriers to enhance the appeal of its technology to potential licensing partners. Without such robust intellectual property protection, negotiations with major pharmaceutical companies would present significant challenges.

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Innovative Delivery System Addresses Patient Needs

BNT23001, the company's promising candidate, utilizes a dissolvable film format containing the active pharmaceutical ingredient Cladribin. This delivery method offers a distinct strategic advantage over conventional tablets like Mavenclad, particularly for MS patients who frequently experience swallowing difficulties (dysphagia).

The proprietary film formulation dissolves directly in the mouth, enabling rapid medication absorption through the mucous membranes. To ensure manufacturing scalability, BioNxt has already completed technology transfers to German partners.

Critical Data Readouts Approaching

For investors, several near-term catalysts warrant close attention. An important bioequivalence animal study is currently underway, with results anticipated imminently. Additionally, the company is preparing to initiate human clinical trials.

BioNxt shares currently trade below their 50-day moving average, reflecting an approximate 10 percent decline over the previous 30 trading sessions. While the newly secured patent protection provides fundamental justification for potential market revaluation, upcoming clinical data will ultimately determine whether the technology delivers on its therapeutic promise.

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