GSK Submits IND Application in China for RSVPreF3 Vaccine Targeting Older Adults

On March 28, the CDE website showed that GSK's respiratory syncytial virus (RSV) vaccine RSVPreF3 (GSK3844766A) had applied for clinical trials in China.

RSVPreF3 is a vaccine developed by GSK to prevent RSV infection in the elderly population, and its formulation includes GSK's proprietary adjuvant system AS01.In October 2022, GSK submitted the marketing application for this product to the FDA, and it is expected that the application will likely be approved in May this year.

The Phase III AReSVi 006 study showed that RSVPreF3 had an overall preventive efficacy of 82.6% against RSV-associated lower respiratory tract disease (RSV-LRTD) and a preventive efficacy of 94.1% against severe RSV-LRTD. In individuals with underlying comorbidities, the preventive efficacy of RSVPreF3 was 94.6%, with 93.8% observed in the 70-79 age group. Additionally, RSVPreF3 demonstrated consistent efficacy in preventing LRTD caused by RSV-A and RSV-B subtypes, at 84.6% and 80.9%, respectively.

In addition to GSK, Pfizer has also developed a vaccine product, PF-06928316, for the prevention of RSV infection in the elderly population. The marketing application for this product is also expected to receive regulatory decision from the FDA in May this year (see: ). The RSV preventive vaccines developed by Nuance Pharma and Advaccine have also entered the late-stage development phase. Additionally, Ark Biosciences has developed a product forTreatment of RSV InfectionGSK's Ziresovir Enteric-Coated Capsules, the product's marketing application received priority review from the National Medical Products Administration (NMPA) in November 2022 (see: ).

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