Dupixent (Dupilumab) Approved in China as First Targeted Biologic for Moderate-to-Severe Atopic Dermatitis in Adults

China Finance Online, June 19 – Sanofi announced today that the National Medical Products Administration (NMPA) has approved dupilumab injection (brand name: Dupixent) for the treatment of moderate-to-severe atopic dermatitis in adults.

It is reported that Dupixent is the world’s first and only targeted biologic agent approved for the treatment of moderate-to-severe atopic dermatitis in adults, and it was approved in China two years ahead of schedule.

Atopic dermatitis (AD) is a refractory, recurrent, inflammatory skin disease characterized primarily by recurrent episodes of intense pruritus and rash. Patients often have comorbid atopic conditions such as allergic rhinitis and asthma.

According to Professor Zhang Jianzhong, the 13th Chairman of the Dermatology and Venereology Branch of the Chinese Medical Association and Director of the Department of Dermatology at Peking University People’s Hospital, the prevalence of atopic dermatitis in China and the severity of its disease burden rank among the highest of all skin diseases. Current treatment primarily relies on topical agents, such as topical corticosteroids, as well as oral corticosteroids and immunosuppressants, with a lack of effective and safe therapeutic options. “Patients with moderate-to-severe atopic dermatitis and their families suffer greatly from the physical, lifestyle, and psychological burdens imposed by this disease, highlighting an urgent need for safe, effective, and long-term manageable systemic treatments.”

Dupixent is a fully human monoclonal antibody that selectively inhibits the key signaling pathways of interleukin-4 (IL-4) and interleukin-13 (IL-13) through an innovative “dual-target” mechanism of action, thereby blocking the type 2 inflammatory pathway, reducing pathological responses associated with type 2 inflammation, and providing mechanistic treatment for type 2 inflammation-related diseases.

Professor Gao Xinghua, Vice President of the First Hospital of China Medical University and Incoming Chair of the Chinese Society of Dermatology and Venereology under the Chinese Medical Association, stated that as a targeted therapy, the approval of Dupixent holds breakthrough significance in the evolution of diagnosis and treatment for atopic dermatitis in China, bringing hope to patients with atopic dermatitis. “It is expected to improve the quality of life for patients and their families, helping them return to normal life.”

It is reported that Dupixent was introduced to the Dermatology Clinical Medical Center of Boao Super Hospital in February 2019. In May 2019, it was included in the second batch of the list of urgently needed overseas new drugs by the Center for Drug Evaluation (CDE) of the National Medical Products Administration, which accelerated the approval process for market launch, resulting in its approval two years ahead of the original schedule.

Sanofi CEO Paul Hudson stated that more than 25 innovative drugs and vaccines are expected to be introduced into China by the end of 2025.

Under a global collaboration agreement, Dupixent was jointly developed by Sanofi and Regeneron. Currently, Dupixent has received regulatory approval and is marketed in approximately 40 countries and regions, including the United States, Japan, and the European Union.