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pp-218

Solution for injection

Dossier type
CTD
Dossier status
Under development
Country of origin
South Korea
GMP approvals
PICS
Comments
Indication: Obesity (overweight/obese adults; severe obesity) Clinical stage: Phase 2 — FDA-cleared and initiated H2 2025 (NCT07205900) Modality: Biological (long-acting GLP-1/GIP/GCG triple receptor agonist peptide — NBE) Mechanism / Target: Balanced co-agonist of GLP-1 receptor (appetite suppression and satiety), GIP receptor (metabolic and adipose function improvement), and glucagon receptor (energy expenditure, lipolysis); optimised activity balance enhances weight loss quantity and quality while reducing lean muscle loss; Hanmi LAPSCOVERY technology confers extended half-life for once-weekly SC dosing Route / form: Subcutaneous injection (once weekly) Differentiation: GLP-1/GIP/GCG triple agonist with potential >25% body weight loss (bariatric surgery-level efficacy); Phase 1 data showed ≈5% weight loss in 4 weeks with favourable safety; Phase 2 initiated H2 2025; best-in-class metabolic profile vs. dual agonists;
Manufacturer #39354
South Korea-based research-based biopharmaceutical company with decades of pharmaceutical expertise. Rx portfolio spans branded generics and novel drugs across metabolic, oncology, and other major therapy areas in solid, injectable, and biologic forms. Pursues global expansion through licensing partnerships with major international pharmaceutical companies.

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