Sanofi's First-in-Class COPD Biologic Dupixent Approved in China Ahead of the US and EU

　　【Pharmaceutical Network Product InformationChronic obstructive pulmonary disease (COPD), characterized by airflow obstruction, is a common chronic condition involving chronic bronchitis and/or emphysema, which can further develop into cor pulmonale and respiratory failure. Its exact cause is still unclear but is believed to result from the combined effects of internal factors (individual susceptibility) and external factors (environmental influences). As a prevalent chronic respiratory disease, COPD poses a serious threat to the health of people in China and imposes a significant economic burden. Currently, the total number of COPD patients in China is approximately 100 million, with an average economic cost per patient being around $942 USD, equivalent to about 6,683 RMB.
 

On September 27, Sanofi announced that Dupixent (dupilumab injection) had been approved by the China National Medical Products Administration for adult patients with chronic obstructive pulmonary disease who have elevated eosinophils and are not well controlled. The approval of this drug came before the United States, and compared to the European Union and the United States, it will benefit patients in China first.
 

The approval of Dupixent was mainly based on the outstanding clinical data from two Phase III clinical trials. The trials evaluated the efficacy and safety of Dupixent in adult smokers or former smokers aged 40-80 years (BOREAS) and 40-85 years (NOTUS) with moderate to severe chronic obstructive pulmonary disease (COPD). Studies have shown that Dupixent can help reduce acute exacerbations, improve lung function, and enhance health-related quality of life.
 

Notably, Dupixent has previously been approved in China for several indications, including moderate-to-severe adult prurigo nodularis, moderate-to-severe atopic dermatitis in adolescents aged 12 years and above as well as adults, and maintenance treatment for asthma in adolescents aged 12 years and above and adults.
 

The industry believes that the approval of Dupixent for the COPD indication in China can bring new hope to more COPD patients who still have poor control after receiving triple therapy.
 

In addition to breakthroughs in treatment, in recent years, the state has successively introduced relevant policies to promote the implementation of chronic respiratory disease prevention and control work.
 

On September 13 this year, the National Health Commission issued the "Notice on Doing a Good Job in Basic Public Health Services for 2024" and the "Health Service Standards for Patients with Chronic Obstructive Pulmonary Disease (Trial)," incorporating COPD into the basic public health service programs. It proposed providing health management services for COPD patients through measures such as health education, screening, and follow-up management to help patients receive early diagnosis and treatment, preventing the deterioration of their condition. The industry believes that the inclusion of COPD in the national basic public health projects will lead to more safeguard measures and treatment plans, allowing more patients to benefit from national support policies.
 

In addition, the "Healthy China Initiative - Action Plan for the Prevention and Treatment of Chronic Respiratory Diseases (2024-2030)" released in July this year proposed to implement a tiered medical treatment system to provide high-risk groups and patients with chronic obstructive pulmonary disease (COPD) full-process prevention and management services including screening intervention, diagnosis, treatment, follow-up management, and functional rehabilitation. This aims to increase the early diagnosis and treatment rate and the standardized management rate of COPD at the grassroots level. By 2030, the prevention and treatment system for chronic respiratory diseases will be further improved, with significantly enhanced grassroots screening capabilities and standardized management levels, and the mortality rate of chronic respiratory diseases among people aged 70 and below will decrease to 8.1 per 100,000 or lower. The inclusion of COPD into the National Essential Public Health Service Program is conducive to further expanding China's prevention and treatment network for chronic respiratory diseases.
 

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