2025-04-18
Moon Biotech recently has announced that its innovative probiotic drug, MNO-863 enteric-coated capsules, has been approved for clinical trials by China’s NMPA. This follows earlier approval from the U.S. FDA, marking a rare dual greenlight across both major regulatory bodies. Medicilon is proud to have been a trusted R&D partner in this achievement, delivering critical preclinical services including toxicity assessments and safety pharmacology studies.
MNO-863: Setting a New Benchmark in “Green Weight Loss”
MNO-863 is a globally patented tumor immunotherapy probiotic drug, and the first of its kind in China to target weight loss. Designed for adults with a BMI ≥ 24 kg/m², this next-generation therapy offers a novel approach to managing obesity through microbiome regulation.
Preclinical studies highlight five key advantages:
- High Efficacy: Nearly 10% weight loss in four weeks with sustained outcomes.
- Synergistic Effects: When combined with GLP-1R agonists, it can drive weight loss exceeding 20%.
- Targeted Fat Loss: Promotes fat loss while preserving muscle mass, differ to conventional drugs.
- Lower Rebound Risk: Maintains results by regulating short-chain fatty acids and metabolic pathways.
- Exceptional Safety: A “green” therapeutic option with potential to improve conditions such as type 2 diabetes and non-alcoholic fatty liver disease.
Medicilon’s Role in Dual Approvals and Global Expansion
With the track record of supporting over 60 dual IND filings across China and the U.S., Medicilon plays a key role in the internationalization drug development.
The Global capabilities include:
- 29,000㎡ GLP Laboratory: Supporting studies across multiple species in line with FDA, TGA, and EMEA standards.
- International Data Compatibility: Ensuring compliance with worldwide regulatory submissions.
Medicilon congratulates Moon Biotech on the approval of MNO-863 and looks forward to its success in clinical trials. Together, we are advancing safer, science-driven solutions to the global obesity challenge.
