By Fineline Cube 
Nuance Pharma announced that its market filing for Ohtuvayre (ensifentrine) as maintenance treatment for patients with Chronic Obstructive Pulmonary Disease (COPD) has been accepted for review by China’s National Medical Products Administration (NMPA).
Regulatory Status & Product Profile
| Item | Detail |
|---|---|
| Company | Nuance Pharma |
| Product | Ohtuvayre (ensifentrine) |
| Mechanism | First‑in‑class phosphodiesterase 3 and 4 (PDE3/PDE4) inhibitor |
| Indication | Maintenance treatment of COPD in adults |
| Delivery | Inhaled via standard nebulizer |
| Status | NMPA filing accepted for review |
| Territory | Greater China |
| Innovation | Dual bronchodilatory and anti‑inflammatory effects in a single compound |
| Market Position | First inhaled maintenance therapy for COPD |
Drug Innovation & Clinical Advantage
- Dual Inhibition: Simultaneous PDE3 and PDE4 blockade delivers both bronchodilation and anti‑inflammatory effects via a single active ingredient
- Delivery Innovation: Administered via standard nebulizer, making it the first inhaled maintenance therapy for COPD, offering convenient outpatient and home‑based treatment
- Clinical Value: Addresses both airway obstruction and underlying inflammation, key drivers of COPD progression and exacerbations
Licensing & Market Access Pathway
- Greater China Rights: Secured via licensing deal with UK‑based Verona Pharma plc in 2021
- Corporate Update: Verona Pharma was acquired by Merck & Co., Inc. (NYSE: MRK) in October 2025
- Regional Access: Approved in Macau (February 2025); became available in the Greater Bay Area (November 2025) via “Hong Kong Macau Drug and Device Access” policy
- Strategic Positioning: Establishes Nuance as the exclusive provider of the only dual‑PDE inhibitor for COPD maintenance in China
Market Impact & Commercial Outlook
- China COPD Burden: Approximately 100 million COPD patients, with 20–30% requiring maintenance therapy
- Market Size: COPD maintenance market valued at ¥15–20 billion (~US$2.1–2.8 billion) annually, growing at 8% CAGR
- Competitive Advantage: First inhaled maintenance therapy offers differentiated delivery vs. oral PDE4 inhibitors and LAMA/LABA combinations
- Pricing Strategy: Expected pricing at ¥15,000–20,000 per patient annually; NRDL inclusion discussions anticipated for 2027
- Revenue Forecast: Analysts project ¥800 million–1.2 billion (US$110–170 million) peak annual sales by 2029, assuming 5% penetration of eligible COPD patients
- Launch Timeline: NMPA review typically 12–18 months; potential approval Q2–Q3 2027 if no major queries
Forward‑Looking Statements
This brief contains forward‑looking statements regarding NMPA review timeline, commercial expectations, and revenue projections for ensifentrine in China. Actual results may differ due to regulatory review outcomes, competitive dynamics, and market adoption rates for inhaled therapies.-Fineline Info & Tech