AstraZeneca’s benralizumab files for new indication in China

On September 2, China's Center for Drug Evaluation (CDE) website showed that a new indication application for AstraZeneca’s benralizumab had been accepted. The application seeks approval for the treatment of adults and adolescents aged 12 years and older with hypereosinophilic syndrome (HES) without a non-hematologic secondary cause. This marks the fourth indication filing for benralizumab in China.

Benralizumab is an innovative biologic that precisely targets eosinophils (EOS) by antagonizing the interleukin-5 receptor (IL-5R). In China, the drug has already been approved for the maintenance treatment of adults and adolescents aged 12 years and older with severe eosinophilic asthma, as well as for children aged 6 to <12 years with severe eosinophilic asthma. Its indication for eosinophilic granulomatosis with polyangiitis (EGPA) has also been submitted to the CDE and accepted for review.

The newly submitted indication is hypereosinophilic syndrome (HES). In the international Phase III NATRON clinical trial, AstraZeneca evaluated the efficacy and safety of benralizumab in patients with HES. The primary endpoint of the study was the time to first worsening or relapse.

In its 2025 H1 financial report, AstraZeneca announced that the NATRON trial had met its primary endpoint. Results showed that, compared with placebo, monthly single injections of benralizumab in HES patients achieved statistically significant and clinically meaningful improvements in the primary endpoint. The safety and tolerability of benralizumab in this trial were consistent with the known profile of the drug. Detailed data will be presented at upcoming medical congresses.

To date, benralizumab has been approved for multiple indications worldwide, including:

• Approval in more than 80 countries and regions, including the US, EU, Japan, and China, for the treatment of adults and adolescents (≥12 years) with severe eosinophilic asthma (SEA);

• Approval in the US and Japan for the treatment of children aged 6–11 years with SEA;

• Approval in more than 35 countries and regions, including the US, EU, and Japan, for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA).

  
  

Since its launch, benralizumab has achieved continuous sales growth. In 2024, global sales reached USD 1.689 billion, representing a year-on-year increase of 8.76%. In the first half of 2025, benralizumab generated USD 920 million in sales, up 18% year-on-year.

In addition, AstraZeneca is developing benralizumab for other indications, including chronic obstructive pulmonary disease (COPD) and hypereosinophilic syndrome (HES). This suggests that benralizumab has the potential for continued growth in the future.

Source: DXY.cn Insight Database