Dupixent Authorized in China as First Biologic Medicine for COPD Patients

The National Medical Products Administration (NMPA) in China has approved Dupixent (dupilumab) as an add-on treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. This approval marks the first instance of a biologic medicine being available for COPD patients in China, following EU approval earlier this year.

Based on two pivotal phase 3 studies, Dupixent significantly reduced COPD exacerbations and improved lung function and quality of life. COPD, the most common chronic respiratory disease in China, is a key focus in the government’s Healthy China 2030 public health plan.

With this, Dupixent is now approved for four indications across respiratory and dermatological diseases in China. The approval brings a novel treatment option to millions of COPD patients who remain inadequately controlled even after maximum inhaled therapy.