中国正在审查GSK的60岁以上成年人的RSV疫苗Arexvy疫苗,预计2027年作出决定。
GSK’s RSV vaccine Arexvy is under review in China for adults 60+, with a decision expected in 2027.
GSK的RSV疫苗Arexvy已被接受,供中国对60岁和60岁以上的成年人进行监管审查,有可能成为中国为这一群体核准的第一种RSV疫苗。
GSK’s RSV vaccine Arexvy has been accepted for regulatory review in China for adults 60 and older, potentially becoming the first approved RSV vaccine for this group in the country.
根据中国提供的积极的第三阶段试验数据,这项申请寻求批准,以预防RSV造成的下呼吸道疾病,这种疾病每年影响600多万成年人,导致350 000多人住院。
The application, based on positive Phase III trial data from China, seeks approval to prevent lower respiratory tract disease caused by RSV, which affects over six million adults annually and leads to more than 350,000 hospitalizations.
预计将于2027年作出决定。
A decision is expected in 2027.
超过65个国家已经批准为60岁以上的成年人接种疫苗。
The vaccine has already been approved in over 65 countries for adults 60 and older.