AstraZeneca (AZN.US) monoclonal antibody new drug approved for two indications in China

Zhitong Finance APP has learned that on August 17, AstraZeneca (AZN.US) announced the official launch of Tezepelumab injection in China. Tezepelumab is a biologic used to treat severe asthma, overcoming phenotype and biomarker level restrictions, and targets thymic stromal lymphopoietin (TSLP).

In March 2026, based on positive results from the DIRECTION and WAYPOINT Phase III clinical studies, Tezepelumab was approved in China for two indications: maintenance treatment for severe asthma in adults and adolescents aged 12 years and above; and, in combination with intranasal corticosteroids, for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients whose disease cannot be adequately controlled with systemic corticosteroids and/or surgery.

Tezepelumab is a human monoclonal antibody jointly developed by AstraZeneca and Amgen, capable of inhibiting the activity of TSLP. TSLP is a key epithelial cytokine upstream of multiple inflammatory cascades, playing a crucial role in the initiation and persistence of allergic, eosinophilic, and epithelium-driven inflammation associated with severe asthma, chronic rhinosinusitis with nasal polyps, and other inflammatory diseases.