When will ensifentrine-Ohtuvayre be launched in China and the latest developments that patients are concerned about

Ensifentrine (Ensifentrine), trade name: Ohtuvayre, is a new type of inhaled dual phosphodiesterase 3 and < /span>4 (PDE3/4) inhibitor, used for the maintenance treatment of chronic obstructive pulmonary disease (COPD). The drug was developed by Verona Pharma, and Nuance Pharma is responsible for research, development and commercialization in mainland China, Hong Kong, Macau and Taiwan.

As of 2025October , exefantine has not been officially launched in mainland China. However,Nuance Pharmahas launched an early medication plan in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan and will launch Ohtuvayre in the region in November 2024 to provide patients with treatment options before the official launch.

In 2025May, the Phase III clinical trial of Ensefentin in ChinaENHANCE-CHINA successfully achieved the primary endpoint and showed significant improvement in lung function. Based on this result, Nuance Pharma plans to submit a new drug marketing application (NDA) to the National Medical Products Administration of China (NMPA) in the second half of 2025.

In Hong Kong, China, Ohtuvayre has been approved by the Drug Administration in February 2025 for maintenance treatment of COPD. However, it has not yet been included in the medical insurance catalog, and patients need to purchase it at their own expense. In Hong Kong pharmacies, 3mg/2.5mL (60doses)OhtuvayreThe price is approximately44,500 Hong Kong dollars.

In short, exefantine has not yet been launched in mainland China, but it has provided patients with treatment opportunities through the early drug program. It is expected that in the second half of 2025, with the submission and review of NDA, Ohtuvayre will be officially launched in the Chinese market.

Reference materials:https://www.drugs.com/