Nuance Pharma Announces Acceptance for Review of the New Drug Application for Ohtuvayre® (ensifentrine) by the National Medical Products Administration of China for the maintenance treatment of chronic obstructive pulmonary disease
SHANGHAI, Jan. 27, 2026 /PRNewswire/ -- Nuance Pharma ("Nuance") today announced that the National Medical Products Administration (NMPA) of China has officially accepted for review the New Drug Application (NDA) for Ohtuvayre® (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease.
Ohtuvayre® is a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 ("PDE3 and PDE4") that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule, delivered directly to the lungs through a standard jet nebulizer.
Mark Lotter, founder and Chief Executive Officer of Nuance Pharma, said: "We are very pleased to see the NDA for Ohtuvayre® has been officially accepted in mainland China. 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."
Charlie Chen, Chief Operating Officer of Nuance Pharma added: "The NDA submission was completed as planned following the positive results from the Phase 3 registrational ENHANCE-CHINA study. 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."
Ohtuvayre® was approved by the Pharmaceutical Administration Bureau Macau in February 2025, and was introduced in the Greater Bay Area in November 2025 through the "Hong Kong and Macau Medicine and Equipment Connect" policy and can be used in designated medical institutions. In November 2024, Nuance Pharma launched Ohtuvayre® in China's Hainan Boao Pilot Zone through an early access program.
In 2021, Nuance Pharma entered into an agreement with Verona Pharma for the exclusive rights to develop and commercialize Ohtuvayre® in Greater China (mainland China, Hong Kong, Macau and Taiwan).
In October 2025, Merck & Co., Inc., Rahway, N.J., USA, known as MSD outside the United States and Canada, announced the completion of the acquisition of Verona Pharma plc.
About Ohtuvayre® (ensifentrine)
Ohtuvayre® is the first inhaled therapy for the maintenance treatment of COPD in adult patients that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Verona has evaluated nebulized Ohtuvayre® in its Phase 3 clinical program ENHANCE ("Ensifentrine as a Novel inHAled Nebulized COPD thErapy") for COPD maintenance treatment. Ohtuvayre® met the primary endpoint in both ENHANCE-1 and ENHANCE-2, demonstrating statistically significant and clinically meaningful improvements in lung function.
About Nuance Pharma
Nuance Pharma is an innovation focused biopharmaceutical company, with both late-stage clinical pipeline and commercial stage asset portfolio. Focusing on specialty care, Nuance has established a differentiated combination of commercialized assets and innovative pipeline across respiratory, pain management, emergency care and iron deficiency anemia. With the mission to address critical unmet medical needs in Asia Pacific, Nuance deploys the Dual Wheel model that develops a global leading innovative pipeline, while maintaining a self-sustainable commercial operation in both China and Asia as a region. For more information, please visit www.nuancepharma.com.
Forward-looking Statements
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SOURCE Nuance Pharma Limited
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