On July 23, the official website of China's NMPA showed that the listing application for the new indication of Sanofi priyuumab has entered the administrative approval stage, or will be approved in the near future. This is the second indication for Duplizumab in China. It is used for moderate to severe atopic dermatitis in adolescents and adults aged 12 years and older who are not well controlled with topical prescription drugs or who are not recommended to use topical prescription drugs.

Dupilumab is a human monoclonal antibody developed by Sanofi that targets IL-4Rα. By combining with IL-4Rα, Duplizumab can simultaneously block the IL-4 and IL-13 signaling pathways. IL-4 and IL-13 are considered to be the main drivers of persistent inflammation in atopic dermatitis.

In March 2017, Duplizumab was approved by the FDA to become the first targeted biologic drug for the treatment of moderate to severe atopic dermatitis in adults. Its trade name is Dupixent®, and its sales amounted to US$251 million in its first year of marketing. Since then, Dupixent has been approved for asthma and nasal polyps indications. In 2019, its global sales were 2.313 billion U.S. dollars, an increase of 150%. The Insight database shows that its sales will continue to skyrocket in 2020, reaching US$4.053 billion.

On June 17, 2020, Duplizumab was approved in China for the treatment of moderate to severe atopic dermatitis in adults. Subsequently, Duplizumab has successively declared two indications, respectively for patients with moderate to severe atopic dermatitis aged 12 years and above, and patients with moderate to severe atopic dermatitis aged 6 to 12 years old. The reasons are included in the priority review and approval.

Atopic dermatitis is a common recurrent, chronic inflammatory skin disease. Patients usually present with a chronic rash characterized by inflammation and itching. Patients with moderate-to-severe atopic dermatitis usually have skin rashes on most parts of the body, causing intense and continuous itching, dry skin, crusting, and exudation, which have a serious impact on the quality of life of patients, but the treatment drugs are very limited. Local therapies such as topical hormones have limited efficacy in patients with moderate to severe atopic dermatitis and are difficult to use for a long time. Systemic treatments such as immunosuppressants or oral glucocorticoids may cause serious side effects.

According to the EvaluatePharma report, Dupixent will become a key driving force for Sanofi’s future growth. With the continuous increase in clinical indications and the continuous expansion of the market, the drug will become the second largest in the world after Aber Repair Merlot in 2024. Big-selling anti-inflammatory drugs, sales will reach 8.058 billion US dollars.