Dupilumab Files Second Marketing Application in China Just Three Months After Initial Approval, Following $2.313 Billion Sales in 2019

Text: Dopine

On September 30, Sanofi’s second marketing authorization application for “Dupilumab Injection” in China was accepted by the Center for Drug Evaluation (CDE), just about three months after the drug’s initial approval in the country.

Dupilumab is a fully human monoclonal antibody developed using Regeneron’s pioneering VelocImmune technology, jointly responsible by Sanofi and Regeneron. By targeting and binding to the IL-4Rα subunit of the shared receptor for IL-4 and IL-13, it blocks downstream signaling of IL-4 and IL-13, thereby alleviating diseases primarily mediated by Th2 cells, including atopic dermatitis, asthma, allergic rhinitis, and food allergies.

In March 2017, dupilumab (brand name Dupixent) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, making it the first FDA-approved biologic for atopic dermatitis. In October 2018, the drug received additional FDA approval as an add-on maintenance treatment for adolescents and adults aged 12 years and older with moderate-to-severe asthma. In June 2019, it was further approved by the FDA, in combination with other medications, for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) whose disease is inadequately controlled.

Furthermore, Dupilumab is also being developed for the treatment of various other inflammatory diseases driven by type 2 inflammation, such as pediatric asthma (Phase III clinical trials), pediatric atopic dermatitis (Phase III clinical trials), adolescent atopic dermatitis (Phase III), eosinophilic esophagitis (Phase III), and chronic obstructive pulmonary disease (Phase III).

To date, dupilumab has received regulatory approval and been launched in approximately 40 countries and regions, including the United States, Japan, and the European Union. Since its market introduction, sales of dupilumab have surged, reaching $251 million, $924 million, and $2.313 billion in 2017, 2018, and 2019, respectively. The industry holds strong optimism regarding the product’s market prospects. In June 2018, the pharmaceutical market research firm EvaluatePharma published a forecast predicting that dupilumab would become the world’s second best-selling anti-inflammatory drug by 2024, trailing only AbbVie’s Humira, with sales reaching $8.058 billion.

In China, dupilumab was included in the Second Batch of Overseas New Drugs Urgently Needed for Clinical Use in May 2019. Its marketing application was accepted by the Center for Drug Evaluation (CDE) in December 2019, and it was approved by the National Medical Products Administration (NMPA) in June 2020 for the treatment of adults with moderate-to-severe atopic dermatitis whose condition is inadequately controlled with topical prescription medications or for whom such therapies are not advisable. The brand name is Dupixent.

On September 28, the CDE website indicated that dupilumab injection was included in the priority review program, with the proposed indication being moderate-to-severe atopic dermatitis in adolescents aged 12 years and older and adults. As the acceptance number was not publicly disclosed, the author speculates that the indication submitted this time is for atopic dermatitis in patients aged 12 years and older; however, specific details remain to be disclosed on the company’s official website.

Furthermore, dupilumab is being developed in China for the treatment of other diseases. According to the Insight database, a total of six clinical trials have been registered for dupilumab to date, with indications including asthma, chronic obstructive pulmonary disease (COPD), spontaneous urticaria, and prurigo nodularis. It is expected that new indications for this drug will continue to be submitted for approval and approved in China in the future.