{"id":58462,"date":"2026-02-28T15:18:04","date_gmt":"2026-02-28T07:18:04","guid":{"rendered":"https:\/\/flcube.com\/?p=58462"},"modified":"2026-02-28T15:18:05","modified_gmt":"2026-02-28T07:18:05","slug":"dupixent-wins-two-nmpa-approvals-in-china-first-biologic-for-bullous-pemphigoid-and-pediatric-asthma-expansion","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=58462","title":{"rendered":"Dupixent Wins Two NMPA Approvals in China \u2013 First Biologic for Bullous Pemphigoid and Pediatric Asthma Expansion"},"content":{"rendered":"\n

Sanofi (NASDAQ:\u202fSNY<\/a>)<\/strong> announced that Dupixent (dupilumab)<\/strong> has been approved by China’s National Medical Products Administration (NMPA)<\/strong> for two new indications<\/strong>: bullous pemphigoid (BP)<\/strong> in adults and maintenance treatment of asthma in children aged 6 and above<\/strong>. The approvals establish Dupixent as China’s first and only targeted biologic for BP<\/strong> and the first anti\u2011IL\u20114R\u03b1 antibody covering pediatric asthma patients \u2265\u202f6 years<\/strong>, expanding access to breakthrough therapy for underserved patient populations.<\/p>\n\n\n\n

Regulatory Milestones<\/h2>\n\n\n\n
Indication<\/th>Patient Population<\/th>Significance<\/th><\/tr><\/thead>
Bullous pemphigoid (BP)<\/strong><\/td>Adult patients<\/td>First and only targeted biologic approved for BP in China<\/strong><\/td><\/tr>
Asthma maintenance<\/strong><\/td>Children aged \u2265\u202f6 years<\/strong><\/td>First anti\u2011IL\u20114R\u03b1 antibody covering pediatric asthma \u2265\u202f6 in China<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Disease Context<\/h2>\n\n\n\n
Disease<\/th>Current Challenge<\/th>Dupixent Value Proposition<\/th><\/tr><\/thead>
Bullous pemphigoid (BP)<\/strong><\/td>Chronic autoimmune blistering disease; glucocorticoids\/immunosuppressants cause significant side effects in elderly patients<\/td>Steroid\u2011sparing targeted therapy<\/strong>; improved safety profile<\/td><\/tr>
Pediatric asthma<\/strong><\/td>Common chronic respiratory disease; overall control levels in China remain unsatisfactory<\/strong><\/td>First biologic maintenance option<\/strong> for children \u2265\u202f6; addresses uncontrolled disease<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Dupixent China and Global Franchise<\/h2>\n\n\n\n
Parameter<\/th>Detail<\/th><\/tr><\/thead>
Mechanism<\/strong><\/td>Inhibition of IL\u20114 and IL\u201113 signaling pathways<\/td><\/tr>
Development<\/strong><\/td>Jointly developed by Regeneron and Sanofi (global collaboration)<\/td><\/tr>
Global Approvals<\/strong><\/td>60+ countries<\/strong><\/td><\/tr>
China Indications (New)<\/strong><\/td>BP (adults); Asthma maintenance (\u2265\u202f6 years)<\/td><\/tr>
Existing Indications<\/strong><\/td>Atopic dermatitis, asthma (adults), CRSwNP, EoE, prurigo nodularis, CSU, COPD<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Strategic Implications<\/h2>\n\n\n\n