According to Nuance Pharma, China’s National Medical Products Administration has accepted the company’s NDA for Ohtuvayre inhaled ensifentrine for the treatment of COPD. Nuance announced in May 2025 that the Phase 3 ENHANCE-CHINA study of nebulized ensifentrine in patients with COPD has met its primary endpoint.
The company acquired the Chinese rights to ensifentrine from Verona Pharma in 2021.That deal also includes the rights to market Ohtuvarye in Macau, Taiwan, and Hong Kong. The company says that ensifentrine is currently available through certain medical facilities in Macau and Hong Kong, as well as in China’s Hainan Boao medical tourism pilot zone under special programs.
In the US, the FDA approved Verona’s Ohtuvayre for the treatment of COPD in June 2024. Verona Pharma was acquired by Merck the following year.
Nuance CEO Mark Lotter commented, “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.”
Chief Operating Officer Charlie Chen said, “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.”
Read the Nuance Pharma press release
