Nuance Pharma announced that the Hong Kong Drug Office has approved Ohtuvayre ensifentrine inhalation suspension for the treatment of COPD. According to Nuance, Ohtuvarye had been available through certain medical facilities in Macau and Hong Kong under a special program since November 2025. The company notes that the application was supported by data from the Phase 3 ENHANCE-CHINA study of nebulized ensifentrine in patients with COPD.
In 2021, Nuance acquired the right to market ensifentrine in China, Hong Kong, Macau, and Taiwan from Verona Pharma. Ohtuvayre was approved by Macau’s Pharmaceutical Administration Bureau in February 2025 and earlier this year, the company announced that China’s National Medical Products Administration had accepted an NDA for Ohtuvayre for the treatment of COPD.
The FDA approved Ohtuvayre for the treatment of COPD in the US in June 2024. Verona was acquired by Merck in 2025, and Merck currently retains the rights to develop ensifentrine in all other markets.
Nuance Pharma CEO Mark Lotter commented, “We are pleased to announce that the Hong Kong regulatory authority has approved the registration of Ohtuvayre under the “1+ mechanism,” which also marks the second regulatory approval outside of the US. We are proud to provide access to this highly innovative COPD treatment to patients in Hong Kong and Macau.”
Read the Nuance Pharma press release
