On September 27, Sanofi announced that dupilumab injection has been approved for a new indication in China, for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD) with type 2 inflammation.(Application No.: JXSS2400002/JXSS2400003)。TheIndications were approved in the U.S. first, and compared to the EU and the U.S., China had the shortest approval time.Once again, it has broken the record for innovative drugs benefiting patients in China.
Image Source: Sanofi Official WeChatDupilumab (Dupixent), a humanized monoclonal antibody jointly developed by Sanofi and Regeneron, works by binding to IL-4Rα, simultaneously blocking the IL-4 and IL-13 signaling pathways, thereby interrupting the Th2-type inflammatory pathway, reducing pathological responses associated with Th2-type inflammation, and treating diseases related to Th2-type inflammation.To date, Dupilumab has been approved globally for multiple indications, includingAtopic Dermatitis, Asthma, Chronic Rhinosinusitis with Nasal Polyps, Chronic Spontaneous Urticaria, Prurigo Nodularis, Eosinophilic Esophagitis, Chronic Obstructive Pulmonary Disease。As the world's first approved IL-4Rα-targeted monoclonal antibody, Dupixent has shown outstanding market performance, with sales surpassing $10 billion in 2023 ($11.589 billion), ranking among the TOP6 best-selling drugs globally in 2023. Moreover, the sales revenue of Praluent in the first half of 2024($6.66 billion)Beyond AbbVie's Adalimumab($5.084 billion)and Johnson & Johnson's Ustekinumab($5.336 billion), becoming the new generation of autoimmune "blockbuster drug."Dupilumab Annual Sales
Image Source:Insight Database
In China, DupilumabEvinacumab has previously received 6 approvals, specifically:Adults with moderate to severe atopic dermatitis (2020/06);
Aged 12 years and above with moderate to severe atopic dermatitis (2021/09);
Moderate to Severe Atopic Dermatitis in Children Aged 6-11 (2022/02);
6 months to 5 years moderate to severe atopic dermatitis (2023/05);
Adult Prurigo Nodularis (2023/09);
Asthma in adolescents aged 12 years and older and adults (2023/11).
It is worth mentioning that Dupilumab isThe first and only targeted biologic agent in China for the treatment of moderate to severe atopic dermatitis in people of all ages.。Results from the Phase 3 BOREAS clinical trial evaluating the efficacy and safety of dupilumab in patients with moderate-to-severe COPD and type 2 inflammation-associated airway disease show:The rate of moderate to severe acute exacerbations of COPD decreased by 30% within 52 weeks (p=0.0005).At week 12, patients in the dupilumab treatment group experienced a 160 mL increase in FEV1 from baseline, compared to 77 mL in the placebo group (p<0.0001). Additionally, the BOREAS study treatment achieved all secondary endpoints.In addition, the Phase 3 clinical trial NOTUS evaluating the efficacy of dupilumab as an add-on treatment for adults with uncontrolled COPD symptoms also achieved positive results:Dupilumab Reduces Disease Worsening by 34% Over 52 WeeksAt week 12, patients in the dupilumab treatment group showed a 139 mL improvement in lung function from baseline, compared to 57 mL in the placebo group (p=0.0001). The benefit persisted until week 52, with the dupilumab group showing an improvement of 115 mL and the placebo group 54 mL (p=0.0182).Chronic Obstructive Pulmonary Disease (COPD) is the most common chronic respiratory system disease, including chronic bronchitis, emphysema, or both. According to WHO statistics, about 600 million people worldwide suffer from COPD, with nearly 100 million patients in China. Research has found that nearly 40% of COPD patients have a disease process mainly driven by type 2 inflammation, and the triple inhaled medications used in traditional treatments have failed to meet their therapeutic needs.Dupilumab inApproved in the EU in July 2024,BecomeThe First Biologic Targeted Drug for the Treatment of COPD, the approval of this indication will further become the driving force for the sales growth of Dupilumab.According to the Insight database, there are currently multiple biologics being developed in China for the treatment of COPD, primarily monoclonal antibody drugs.These drug targets are relatively concentrated in IL-33, IL-4R, TSLP, etc.In terms of R&D progress, AstraZeneca's Benralizumab and Roche's Astegolimab, etc.Has entered Phase III clinical trials.In China, pharmaceutical companiesConnemara'sSuptilibimab has enteredPhase II/III Clinical Trials`, closely following the progress of imported drugs`In addition, SSGJ-611 from 3SBio and Mabwell's9MW1911、Maiji BiotechnologyMG014 Has also entered the clinical stage。Monoclonal Antibody Drugs for COPD in Clinical Stage in China
Data Source:Insight Database, Statistics as of 20240914
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