Approval marks the second regulatory approval outside of the U.S. Food and Drug Administration, further expanding access to COPD patients in select Special Administrative Regions (SARs) in Greater China

Nuance Pharma ("Nuance") announced that the Hong Kong Drug Office approved Ohtuvayre® (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients under the "1+ mechanism."

Ohtuvayre® is the first novel inhaled mechanism for the treatment of COPD in more than 20 years and combines bronchodilator and non-steroidal anti-inflammatory effects. The U.S. Food and Drug Administration approved Ohtuvayre in June 2024 for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.

The approval of Ohtuvayre in Hong Kong SAR, China, was based on the Global Phase 3 ENHANCE trials and referencing the completed ENHANCE-CHINA trial. In the ENHANCE trials, Ohtuvayre demonstrated clinical benefits both alone and when used in combination with a LABA, a LABA+ICS, a LAMA, or a LAMA+ICS.

Mark Lotter, founder and Chief Executive Officer of Nuance Pharma, said: "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 U.S. We are proud to provide access to this highly innovative COPD treatment to patients in Hong Kong and Macau."

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 January 2026, Nuance Pharma announced acceptance for review of the new drug application for Ohtuvayre by the national medical products administration of China.

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.