Complexing-Protein-Free-Naked-Toxin-Purification

Recombinant and next-generation engineered botulinum neurotoxins (BoNT) — expressed via DNA technology or reformulated as complex-free / ready-to-use liquids — are displacing traditional Clostridium botulinum fermentation: AbbVie/Allergan's Boey® (trenibotulinumtoxinE, recombinant serotype E) won EU and Health Canada approval in 2026 with onset as early as 8 hours and a 2-3 week duration across 2,100+ Phase 3 patients; Galderma's Relfydess™ (relabotulinumtoxinA, PEARL™ Technology ready-to-use liquid) reached 33 markets including EU approval across 16 countries in 2026; Merz's Xeomin (incobotulinumtoxinA, complexing-protein-free naked toxin) holds 79-country approval; Eirion's AI-09 ready-to-use recombinant liquid injectable achieved 6-month duration at the highest dose in a 96-subject Phase 1-2 trial. China's Lanzhou/CNBG Hengli® (衡力) — the country's first domestic BoNT-A (2002 approval, 30+ years lineage) — leads the local market with first-in-China 2025-2026 approvals for axillary hyperhidrosis and benign masseter hypertrophy while domestic recombinant R&D remains pre-commercial.