BioNxt Reports "Readiness to Grant" Patent Notification from the Eurasian Patent Organization

Executive Summary

• The Eurasian Patent Organization issued a “Readiness to Grant” notification for BioNxt’s patent covering sublingual delivery of anticancer drugs, including lead product BNT23001 for multiple sclerosis.
• Formal grant is expected once the publication fee is paid this week, securing protection across eight Eurasian markets with a combined population >200 million.
• The company is about to begin a two‑week large‑mass animal bioequivalence study, positioning it for upcoming human trials and broader clinical advancement.

Key Details

• Patent Scope: Covers Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, Turkmenistan (Eurasian Patent Convention members).
• Technology Covered: Sublingual thin‑film formulation of anticancer drugs; lead product BNT23001 (sublingular Cladribine for MS).
• Status: “Readiness to Grant” – formal patent will be issued after payment of the EAPO publication fee (to be paid this week).
• Strategic Importance: Provides BioNxt with exclusive rights in a high‑population region, supporting commercialization strategy and enhancing IP portfolio value.
• Regulatory Progress: Favorable communications from both European Patent Office and Eurasian Patent Office confirming novelty, inventive step, and industrial applicability.
• Parallel Filings: Nationalization underway in EU, Canada, Australia, New Zealand, Japan; Track‑One priority filing pending in the United States.
• Upcoming Milestones: Commencing a two‑week large‑mass animal bioequivalence study to define dosing parameters for an imminent human bioequivalence trial.

Notable Quotes

“Solidifying patent protection is a critical part of our commercialization strategy,” said Hugh Rogers, CEO of BioNxt. “The timing is excellent as the Company is days away from commencing a two‑week‑long large‑mass animal bioequivalence study… The coming months are expected to be very exciting for BioNxt as multiple clinical programs advance and our intellectual property portfolio gains international recognition and protection.”