Exclusive Summary

• Backed by dual US-FDA and EU-EMA GMP certifications with approved registration in Germany, providing the highest global quality validation for fast-track market entry in PIC/S countries.
• Features a high-barrier Extended Release (ER) formulation with a dual MOR/NRI mechanism, delivering comparable efficacy to strong opioids for chronic pain and DPN but with significantly reduced gastrointestinal and abuse-related side effects.
• Strategically timed to target imminent extended-release patent cliffs (e.g., upcoming Spain approval in Q2 2028), offering overseas distributors disruptive pricing advantages and immense margins driven by robust Chinese supply chain efficiency.