Ohtuvayre® (ensifentrine) helped improve lung function in Chinese adult patients in in data published in peer reviewed journal
SHANGHAI, April 20, 2026 /PRNewswire/ — Nuance Pharma (“Nuance” or the “Company”) announces that CHEST, the official journal of the American College of Chest Physicians, has published results from the Phase 3 ENHANCE-CHINA trial evaluating Ohtuvayre® (ensifentrine) in chronic obstructive pulmonary disease (“COPD”).
The publication reports results from Nuance’s successful ENHANCE-CHINA trial demonstrating improvements with ensifentrine in lung function and dyspnea, with a demonstrated safety profile. The manuscript, entitled “Efficacy and Safety of Ensifentrine in Chinese Patients with Chronic Obstructive Pulmonary Disease: The ENHANCE-CHINA Randomized Clinical Trial,” is available online here and will be published in an upcoming issue of CHEST. It follows the announcement of top-line data from the ENHANCE-CHINA trial in May 2025.
Data from the ENHANCE-CHINA program formed the basis of Nuance Pharma’s New Drug Application (“NDA”), which was submitted in December 2025 to the National Medical Products Administration (“NMPA”) for the approval of ensifentrine for the maintenance treatment of patients with COPD.
Ensifentrine is FDA-approved in the United States as maintenance treatment for adult patients with COPD with a selective dual inhibitor of the enzymes phosphodiesterase 3 and 4, combining bronchodilator and non-corticosteroid anti-inflammatory activities in one molecule. If approved in China, it is expected to be the first novel mechanism of action available for the treatment of COPD in more than 10 years.
Mark Lotter, founder and Chief Executive Officer of Nuance Pharma, said: “We are delighted to see the full results from our Phase 3 ENHANCE-CHINA trial published in CHEST, a highly respected peer-reviewed journal in pulmonary medicine. These data reinforce the robust clinical profile of ensifentrine, demonstrating meaningful improvements in lung function. With our New Drug Application already submitted and accepted for review by the NMPA, we are one step closer to bringing this first-in-class inhaled therapy to patients in China. We extend our sincere gratitude to the patients, investigators, and clinical site teams who made this program possible.”
In March 2026, Ohtuvayre was approved by the Hong Kong Drug Office under the “1+”mechanism. In February 2025, Ohtuvayre was approved by the Pharmaceutical Administration Bureau Macau, 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 January 2026, Nuance Pharma announced acceptance for review of the new drug application for Ohtuvayre by the National Medical Products Administration of China. 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. MSD holds the exclusive rights to develop and commercialize Ohtuvayre in all markets outside of Greater China.
About the ENHANCE-CHINA Program
The randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of nebulized ensifentrine as monotherapy and added onto either a LAMA or a LABA, or a LABA+ICS compared to placebo.
- Patient Population: 526 moderate to severe, symptomatic, COPD patients at 46 sites in China.
- Dose/Duration: subjects were randomized to receive a 3mg nebulized dose of ensifentrine or nebulized placebo twice daily for 24 weeks
- Primary Endpoint: Improvement in lung function with ensifentrine as measured by average FEV1 AUC 0-12 hours post dose at week 12.
- Secondary Endpoints: lung function endpoints including peak and morning trough FEV1, COPD symptoms and health related quality of life through 24 weeks via SGRQ and E-RS, and exacerbation at 24 weeks, and others
- Safety: Assessed over 24 weeks
Further information about the ENHANCE-CHINA program can be found at www.clinicaltrials.gov (NCT05743075).
About Ensifentrine (Ohtuvayre®)
Ohtuvayre® is the first inhaled therapy for the maintenance treatment of COPD in adult patients that combines bronchodilator and non-corticosteroid anti-inflammatory activities in one molecule. Ohtuvayre was evaluated in a 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.
Ohtuvayre Indication and Important Safety Information
INDICATION
Ohtuvayre is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.
IMPORTANT SAFETY INFORMATION
Contraindication: Ohtuvayre is contraindicated in patients with hypersensitivity to ensifentrine or any component of this product.
Warnings and Precautions:
Acute Episodes of Bronchospasm Ohtuvayre should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled, short-acting bronchodilator.
Paradoxical Bronchospasm As with other inhaled medicines, Ohtuvayre may produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with Ohtuvayre, it should be treated immediately with an inhaled, short-acting bronchodilator. Ohtuvayre should be discontinued immediately and alternative therapy should be instituted.
Psychiatric Events Including Suicidality Before initiating treatment with Ohtuvayre, healthcare providers should carefully weigh the risk and benefits of treatment with Ohtuvayre in patients with a history of depression and/or suicidal thoughts or behavior. Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts, or other mood changes, and if such changes occur to contact their healthcare provider. Healthcare providers should carefully evaluate the risks and benefits of continuing treatment with Ohtuvayre if such events occur.
Treatment with Ohtuvayre is associated with an increase in psychiatric adverse reactions. Psychiatric events including suicide-related adverse reactions were reported in clinical studies in patients who received Ohtuvayre (1 suicide attempt and 1 suicide). Additionally, the most commonly reported psychiatric adverse reactions in the pooled 24-week safety population were insomnia (6 patients [0.6%] Ohtuvayre 3 mg; 2 patients [0.3%] placebo), and anxiety (2 patients [0.2%] Ohtuvayre 3 mg; 1 patient [0.2%] placebo). Depression-related reactions including depression, major depression, and adjustment disorder with depressed mood occurred in 4 patients [0.4%] receiving Ohtuvayre and no patients receiving placebo.
Adverse Reactions: The most common adverse reactions ≥1% in Ohtuvayre and greater than placebo in the pooled population were back pain 1.8%, hypertension 1.7%, urinary tract infection 1.3%, and diarrhea 1.0%.
These are not all of the possible risks associated with Ohtuvayre.
Please see Prescribing Information for Ohtuvayre (ensifentrine) at: https://ohtuvayrehcp.com/wp-content/uploads/sites/2/2024/11/Ohtuvayre-US-Prescribing-Information.pdf, Patient Information for Ohtuvayre at: https://ohtuvayre.com/wp-content/uploads/2024/11/Ohtuvayre-US-Prescribing-Information.pdf.
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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