Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by recurring symptoms, with the CIC report indicating that China had more than 54 million people living with AD in 2024.
If approved and launched, the vaccine will complement CanSinoBIO’s recently approved three-component DTaP vaccine, Tripecia® (DT3cP Infant), expanding the company’s pertussis-containing vaccine portfolio across age groups.
The latest approval expands the clinical use of ivonescimab in China and follows previous NMPA authorisations for regimens containing the molecule.
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.