China's NMPA Accepts Review of Ohtuvayre for COPD Maintenance Treatment
核心洞察
China's National Medical Products Administration (搜索) has officially accepted for review the New Drug Application for Ohtuvayre (搜索) (ensifentrine), a first-in-class dual PDE3 (搜索)/PDE4 (搜索) inhibitor for chronic obstructive pulmonary disease maintenance treatment.
The NDA submission follows positive results from the Phase 3 registrational ENHANCE-CHINA study, marking a significant regulatory milestone for this innovative nebulized therapy.
Ohtuvayre (搜索) combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule, potentially redefining COPD treatment for millions of patients in China.
Nuance Pharma (搜索) announced that China's National Medical Products Administration (搜索) (NMPA) has officially accepted for review the New Drug Application (NDA) for Ohtuvayre (搜索)® (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease. The regulatory milestone represents a significant step toward bringing this first-in-class therapy to millions of COPD patients in mainland China.
Novel Dual-Action Mechanism
Ohtuvayre (搜索)® is a first-in-class selective dual inhibitor of phosphodiesterase 3 (搜索) and 4 (PDE3 (搜索) and PDE4 (搜索)) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. The therapy is delivered directly to the lungs through a standard jet nebulizer, offering a unique approach to COPD maintenance treatment.
"We are very pleased to see the NDA for Ohtuvayre (搜索)® has been officially accepted in mainland China," said Mark Lotter, founder and Chief Executive Officer of Nuance Pharma (搜索). "This exciting milestone affirmed our confidence in ensifentrine's potential to re-define the COPD treatment in China. We are committed to expanding access to Ohtuvayre®, if approved, with the goal of benefiting millions of patients battling with COPD."
Phase 3 Study Success Drives Regulatory Filing
The NDA submission was completed following positive results from the Phase 3 registrational ENHANCE-CHINA study. Charlie Chen, Chief Operating Officer of Nuance Pharma (搜索), noted that the submission proceeded as planned based on these encouraging clinical outcomes.
Verona Pharma previously evaluated nebulized Ohtuvayre (搜索)® in its Phase 3 clinical program ENHANCE ("Ensifentrine as a Novel inHAled Nebulized COPD thErapy") for COPD maintenance treatment. The therapy met the primary endpoint in both ENHANCE-1 and ENHANCE-2, demonstrating statistically significant and clinically meaningful improvements in lung function.
Expanding Access Across Greater China
Ohtuvayre (搜索)® has already gained regulatory traction in the region. The Pharmaceutical Administration Bureau Macau approved the drug in February 2025, and it was subsequently introduced in the Greater Bay Area in November 2025 through the "Hong Kong and Macau Medicine and Equipment Connect" policy for use in designated medical institutions.
Nuance Pharma (搜索) launched Ohtuvayre (搜索)® in China's Hainan Boao Pilot Zone through an early access program in November 2024. "Following our ongoing early access programs in Hainan BoAo and Greater Bay Area, as well as regulatory approval in Macau, we look forward to accelerating patient access to this innovative medicine in China," Chen added.
Strategic Partnership and Corporate Developments
In 2021, Nuance Pharma (搜索) entered into an agreement with Verona Pharma for the exclusive rights to develop and commercialize Ohtuvayre (搜索)® in Greater China, including mainland China, Hong Kong, Macau and Taiwan. The pharmaceutical landscape shifted in October 2025 when Merck & Co (搜索)., Inc. (known as MSD outside the United States and Canada) announced the completion of its acquisition of Verona Pharma plc.
Nuance Pharma (搜索) operates as an innovation-focused biopharmaceutical company with both late-stage clinical pipeline and commercial stage asset portfolio. The company focuses on specialty care with a differentiated combination of commercialized assets and innovative pipeline across respiratory, pain management, emergency care and iron deficiency anemia.