Sanofi's Blockbuster Drug Dupixent Nears China Approval for Moderate-to-Severe Atopic Dermatitis

Text | Baihuawen

On June 16, PharmaCube Plus issued an alert indicating that the status of Sanofi’s marketing application for dupilumab injection (brand name: Dupixent) in China had changed to “under review.” The drug is expected to receive formal approval in China shortly for the treatment of moderate-to-severe atopic dermatitis.

Dupixent (dupilumab) is a monoclonal antibody drug targeting IL-4R, co-developed by Sanofi and Regeneron. It binds to the IL-4Rα subunit shared by the receptors for IL-4 and IL-13, thereby simultaneously blocking IL-4 and IL-13 signaling, and demonstrates effective control over various type 2 immune-mediated inflammatory diseases.

Dupixent was first approved by the FDA in March 2017, with global sales reaching €2.074 billion in 2019, demonstrating remarkable market momentum. Currently, Dupixent has been approved for three indications: asthma, chronic rhinosinusitis with nasal polyps, and atopic dermatitis. In the field of atopic dermatitis, Dupixent has gradually expanded its coverage to include all patients aged 6 years and older. Furthermore, clinical trials targeting patients aged 6 months to 5 years with atopic dermatitis have advanced to Phase II/III.

Source: NextPharma

In Sanofi’s six-year strategic plan announced in December 2019, then-new CEO Paul Hudson identified Dupixent, vaccines, the R&D pipeline, and the Chinese market as the four key strategic pillars driving Sanofi’s future growth, including the goal of establishing dupilumab as a blockbuster drug with annual sales exceeding €10 billion.

On June 11, Sanofi presented in detail the future development plans for Dupixent at its Investor R&D Open Day, revealing the rationale behind the expectation of a peak sales potential of over €10 billion for Dupixent.

Atopic dermatitis is a chronic, relapsing, inflammatory skin disease and the most common type of eczema. More than half of the patients seeking medical care at hospitals have moderate-to-severe disease, characterized primarily by extensive rashes and intolerable, intense pruritus. These patients experience a poor quality of life, often accompanied by psychiatric comorbidities such as sleep disorders, anxiety, and depression, which severely impair their learning, work, and social activities.

The indication of dupilumab for the treatment of moderate-to-severe atopic dermatitis was included in China’s “Second Batch of Clinically Urgent Overseas Drugs” list in May 2019. On December 25, Sanofi submitted a marketing application for this drug in China.

Sanofi has registered a total of seven clinical trials for dupilumab in China, covering multiple indications including chronic spontaneous urticaria, moderate-to-severe atopic dermatitis in adult patients, moderate-to-severe chronic obstructive pulmonary disease (COPD) with type 2 inflammation, asthma, and prurigo nodularis.

Source: PharmaGo