Bionxt Solutions receives semaglutide API

Executive Summary

• Bionxt Solutions Inc. has received the semaglutide active pharmaceutical ingredient (API), enabling the start of laboratory-scale formulation and testing for its proprietary oral dissolvable film (ODF) delivery system.
• Development activities are being conducted at Gen-Plus GmbH in Munich, Germany, focusing on optimizing drug incorporation, disintegration time, and peptide stability.
• The company plans to file a provisional patent for the semaglutide ODF in the third quarter of 2025, following the completion of initial formulation trials and prototype production.

Key Details

• API Acquisition: Bionxt secured high-purity semaglutide from qualified supply partners to serve as the central compound for its ODF formulation program.
• R&D Focus: Initial efforts include optimizing drug incorporation within the sublingual thin-film matrix, characterizing disintegration time, testing peptide stability under formulation conditions, and developing analytical methods for uniformity, controlled release, and shelf-life performance.
• Development Partner: All laboratory development is conducted at Gen-Plus GmbH, a licensed drug developer and manufacturer specializing in pharmaceutical thin-film formulations and novel dosage forms.
• Facility Capabilities: The Munich facility provides GMP-aligned laboratory infrastructure, in-house expertise in polymer science and peptide formulation, and regulatory readiness for EU clinical development.
• Next Milestones: Completion of formulation trials, characterization of peptide stability, and production of first-generation film prototypes.
• Patent Strategy: A provisional patent filing is planned for the third quarter of 2025.
• Market Context: Semaglutide (marketed as Ozempic and Rybelsus) is a leading GLP-1 receptor agonist for Type 2 diabetes and obesity, with global sales exceeding $29.3 billion in 2024.
• Strategic Positioning: The ODF format aims to improve accessibility and patient compliance through a non-invasive delivery method. Semaglutide is the first in a planned series of GLP-1-based therapies using Bionxt's proprietary ODF platform.

Notable Quotes

• "Having the API in-house allows us to translate theory into practice," said Hugh Rogers, chief executive officer 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."