The decision makes satri-cel the first CAR-T therapy anywhere in the world to receive regulatory approval for a solid tumor indication.
The product will be manufactured and commercialized to support treatment and prevention needs during influenza seasons, with an emphasis on improving availability for younger patients across China.
The medication works as an add-on therapy alongside intranasal corticosteroids for patients whose condition fails to respond adequately to systemic corticosteroids or surgical intervention.
The NMPA based its approval decision on Phase III clinical trial data published in The Lancet Diabetes & Endocrinology in June 2025.
The NMPA based its decision on compelling evidence from the TRIDENT-1 study, a pivotal Phase I/II clinical trial that demonstrated the drug’s effectiveness over time.