By Fineline Cube 
Jiangsu Jebel Pharma Co., Ltd. (SHA: 688566) today announced that its novel antidepressant JJH201501, developed through the company’s proprietary deuterated‑drug platform, achieved statistically significant efficacy in a global Phase III clinical trial.
Clinical Trial Highlights
- Design – Randomized, double‑blind, placebo‑controlled Phase III study involving 1,200 patients with moderate‑to‑severe major depressive disorder.
- Dosing Regimen – 10 mg, 15 mg, and 20 mg daily tablets.
- Primary Endpoint – Change from baseline in the Montgomery‑Åsberg Depression Rating Scale (MADRS) at 8 weeks.
- Results – Both the 10 mg and 15 mg doses produced significantly greater MADRS reductions versus placebo (p < 0.001).
- Comparative Efficacy – The 10 mg and 15 mg groups were non‑inferior to the 20 mg Vortioxetine Hydrobromide cohort, demonstrating a favorable dose‑response profile.
About JJH201501
- Class I Antidepressant – Features a multi‑receptor mechanism (serotonin, norepinephrine, and dopamine modulation) that delivers rapid and sustained symptom relief.
- Deuterated Technology – Enhances metabolic stability, potentially improving tolerability and allowing lower effective doses.
- Safety Profile – Adverse events were mild to moderate and comparable to placebo, with no serious safety signals reported.
Strategic Implications for Jebel Pharma
- Market Positioning – JJH201501 represents a first‑in‑class therapeutic offering that may fill an unmet need for patients requiring rapid onset and low‑dose antidepressant therapy.
- Regulatory Pathway – The robust Phase III data will support submissions to the FDA, EMA, and other major regulatory authorities in 2026.
- Growth Outlook – Successful commercialization could drive revenue expansion and reinforce Jebel Pharma’s reputation as a leader in deuterated‑drug development.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech