GSK(US:GSK) Bei Ke Cai Jing·2026-02-12 04:38Core Viewpoint - GlaxoSmithKline (GSK) has submitted a marketing application for its respiratory syncytial virus (RSV) vaccine for adults aged 60 and above, which, if approved, will be the first vaccine authorized by the National Medical Products Administration (NMPA) in China for this demographic to prevent RSV-related lower respiratory diseases [1][2]. Group 1: Vaccine Application and Approval - The NMPA has accepted GSK's application for the RSV vaccine, which targets adults aged 60 and above [1]. - If approved, this vaccine will be the first of its kind in China to help prevent the potential consequences of RSV in older adults [1]. Group 2: RSV Impact and Statistics - RSV is a common and contagious virus that affects approximately 64 million people globally each year, with older adults facing higher risks due to chronic diseases and age [1]. - In China, over 6 million individuals aged 60 and above are affected by RSV annually, leading to more than 350,000 related hospitalizations [1]. Group 3: Clinical Trial Results - The data submitted for the marketing application includes positive results from a Phase III clinical trial assessing the vaccine's safety and immunogenicity in adults aged 60 and above in China [2]. - All primary endpoints of the clinical trial were met, and the safety data of the vaccine aligns with expectations [2]. - The regulatory authority is expected to make a decision on the application next year [2].