AstraZeneca's Biologic Therapy Receives Dual Indication Approval for Launch in China

Stock News
Aug 18

On August 17, AstraZeneca PLC (AZN.US) announced the official market launch of Tezepelumab injection in China. This biologic is designed to address severe asthma, overcoming limitations related to phenotype and biomarker levels, by specifically targeting thymic stromal lymphopoietin (TSLP).

In March 2026, Tezepelumab received approval in China for two indications, based on positive results from the Phase 3 clinical trials DIRECTION and WAYPOINT. The first is for maintenance treatment of severe asthma in adults and adolescents aged 12 years and older. The second combines the drug with intranasal corticosteroids for treating chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients whose condition is not adequately controlled by systemic corticosteroids and/or surgical intervention.

Developed collaboratively by AstraZeneca and Amgen, Tezepelumab is a human monoclonal antibody that inhibits TSLP activity. TSLP, a key epithelial cytokine situated upstream of multiple inflammatory cascades, plays a central role in the initiation and persistence of allergic, eosinophilic, and epithelial-driven inflammation associated with severe asthma, CRSwNP, and other inflammatory conditions.

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