Nuance Pharma's Ohtuvayre Receives Regulatory Approval in Macau for COPD Treatment

Nuance Pharma’s Ohtuvayre Receives Regulatory Approval in Macau for COPD Treatment

China-based Nuance Pharma announced that it has received regulatory approval in Macau for its Ohtuvayre (ensifentrine) as a maintenance treatment for chronic obstructive pulmonary disease (COPD). This approval marks a significant milestone in the company’s efforts to expand the availability of Ohtuvayre in the Greater China region.

Innovative Dual-Inhibitor Therapy
Ensifentrine is a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3; PDE4), combining bronchodilator and non-steroidal anti-inflammatory effects in one molecule. It is delivered directly to the lungs through a standard jet nebulizer, eliminating the need for high inspiratory flow rates or complex hand-breath coordination. This makes it a convenient and effective treatment option for patients with COPD.

Strategic Partnerships and Market Expansion
In June 2021, Nuance Pharma entered into an agreement with Verona Pharma for the exclusive rights to develop and commercialize Ohtuvayre in Greater China, including mainland China, Hong Kong, Macau, and Taiwan. The drug received marketing approval as a maintenance treatment for COPD in the United States in June of the previous year and gained market access in Boao Lecheng in November of the same year.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry