Sanofi's Dupixent (dupilumab) has received marketing authorisation in China for two new indications: the treatment of adults with bullous pemphigoid (BP) and as a maintenance therapy for asthma in children aged 6 and above. The approval for BP marks dupilumab as the first and only targeted biologic therapy for this condition in China. The asthma approval extends the drug's use to a paediatric population as young as 6 years old, making it the first anti-IL-4Rα monoclonal antibody (mAb) to cover this age group for asthma in China.

Dupixent, a fully human mAb that inhibits signalling of IL-4 and IL-13, is now approved in China for nine different conditions and patient populations. These include atopic dermatitis, asthma, chronic obstructive pulmonary disease (COPD), prurigo nodularis and now bullous pemphigoid. Globally, the drug is approved in over 60 countries for multiple type 2 inflammatory diseases and has been used by more than 1.2 million patients.

PharmCube's NextBiopharm® database lists 17 dupilumab biosimilar projects globally, anticipating Dupixent's first patent expirations in 2029. Click here to request a free trial for NextBiopharm®.