AstraZeneca's New Drug Application Accepted, Expected to Be a Market Focus in 2026

On November 22, 2024, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that the marketing application for Tezeliumab injection jointly submitted by AstraZeneca and Amgen has been officially accepted. According to public information, the drug is a monoclonal antibody targeting against thymic stromal lymphocyte opoietin (TSLP), called tezepelumab (trade name Tezspire). The therapy was approved by the U.S. Food and Drug Administration (FDA) in December 2021 as an add-on maintenance therapy for the treatment of severe asthma in children and adults 12 years and older. According to Clarivate analysis, the treatment is expected to become an important new drug on the market in 2026.

According to the registration classification of the declaration, it can be inferred that the indications applied for marketing of the product in China may include the treatment of severe asthma in children and adults aged 12 years and above. At the same time, the product pipeline information on Astrazeneca's official website also indicates that it plans to declare the first indication in the Chinese market for the treatment of severe asthma.

The FDA's approval is based on a clinical development program called PATHFINDER, which includes results from the pivotal Phase 3 clinical trial NAVIGATOR. The results of the NAVIGATOR trial were published in the New England Journal of Medicine in May 2021. The results show that tezepelumab met all primary endpoints and key secondary endpoints when treating patients with severe asthma with uncontrolled symptoms. Compared with placebo, the drug reduced the annual rate of acute exacerbations of asthma (AAER) by 56%.

In addition to severe asthma, tezepelumab is also in development for the treatment of other potential indications, including chronic obstructive pulmonary disease, chronic sinusitis with nasal polyps, chronic spontaneous urticaria and eosinophilic esophagitis. The product also received breakthrough therapy designation from the FDA in August as an additional maintenance therapy for patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).