An introduction to the official launch time of ensifentrine-Ohtuvayre and the progress of its marketing in China

Ensifentrine (Ensifentrine), trade nameOhtuvayre, is a new type of dual phosphodiesterase(Dual PDE3/4) inhibitor, used for the treatment of chronic obstructive pulmonary disease (COPD). The drug has been approved for marketing by the FDA in the United States, providing a new inhaled treatment option for patients with COPD, especially showing good efficacy in patients for whom traditional bronchodilators or inhaled corticosteroids are unsatisfactory.

In the Chinese market, exefantine has not been approved for marketing by the domestic Food and Drug Administration, nor has it been included in the national medical insurance directory. This means that domestic patients are currently unable to purchase the drug directly in hospitals or pharmacies through formal channels and must rely on overseas channels or cross-border drug purchases, which limits its widespread clinical use.

At present, prices in overseas markets are relatively high. The US version of Ohtuvayre 3mg/2.5mL (60 doses) is sold in Hong Kong pharmacies at about 44,500 Hong Kong dollars per box, which is significantly higher than the price of conventional domestic treatment drugs. This may become a burden for long-term treatment for patients with limited financial ability, and also limits the popularity and clinical application of the drug.

For future promotion prospects in China, relevant companies still need to complete domestic clinical trials and registration approval processes, and formulate reasonable pricing strategies based on medical insurance policies after passing the approval. As the clinical application data of the drug accumulates around the world, and the efficacy and safety of patients with COPD are further verified, the promotion potential of exefantine in the Chinese market deserves attention, but in the short term, it will still mainly rely on international market supply.

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