Over 40% of Adults Struggle to Swallow Pills - BioNxt Targets a Global Adherence Problem with Rapid-Dissolving Thin-Film "Melt-in-Your-Mouth" Therapies

Executive Summary

• BioNxt Solutions Inc. announced the issuance of its first national‑level patent (Eurasian) covering BNT23001, a sublingual cladribine thin‑film for multiple sclerosis and myasthenia gravis.
• The company has completed GMP clinical batch manufacturing of BNT23001 and is preparing a comparative human bioequivalence study slated for Q1 2026.
• BioNxt highlighted the broader scalable thin‑film platform, its expanding global IP portfolio, and the large addressable markets for autoimmune therapies (combined $75–$80 bn) and oral transmucosal drug delivery ($45.8 bn in 2025, projected $96.8 bn by 2033).

Key Details

• Patent Grant: First issued Eurasian patent covering BNT23001, valid through 2043; protects >200 million people across eight member states. Additional applications pending in Europe, North America, and Asia‑Pacific.
• Product Focus: BNT23001 is a proprietary sublingual cladribine thin‑film intended for MS and MG; cladribine tablets (Mavenclad®) have >US$1 bn annual sales.
• Manufacturing & Clinical Plan: GMP clinical batch of BNT23001 completed; comparative human bioequivalence study planned for Q1 2026, leveraging an accelerated regulatory pathway due to existing oral approval of cladribine.
• Platform Strategy: Thin‑film technology is platform‑based, enabling reformulation of multiple approved drugs across autoimmune and chronic disease categories; shared manufacturing infrastructure reduces development risk and capital requirements.
• Market Opportunity:
• Global MS drug market projected $40–$45 bn by 2033.
• Global MG treatment market projected $2.7–$4.7 bn by 2032.
• Combined autoimmune drug spending expected to exceed $75–$80 bn annually over the next decade.
• Oral transmucosal drug‑delivery market forecast to grow from $45.8 bn (2025) to $96.8 bn (2033).
• Regulatory Outlook: Anticipated bioequivalence‑driven pathway expected to shorten development timelines, lower clinical risk, and reduce capital needs versus de novo drug programs.

Notable Quotes

“When up to 40% of adults report difficulty swallowing pills, and dysphagia affects roughly 45% of patients with multiple sclerosis, the dosage form becomes a key driver of adherence – not a secondary consideration,” said Hugh Rogers, CEO of BioNxt Solutions Inc.

All forward‑looking statements are subject to risks and uncertainties that could cause actual results to differ materially.